Digital Headache Self-Management Interventions for Patients with a Primary Headache Disorder: A Systematic Review of Randomized Controlled Trials

Amy Noser; Robert Gibler; Rachelle Ramsey; Rebecca Wells; Elizabeth Seng; Kevin Hommel

doi:10.1111/head.14392

. Author manuscript; available in PMC: 2023 Oct 1.

Published in final edited form as: Headache. 2022 Oct;62(9):1105–1119. doi: 10.1111/head.14392

Digital Headache Self-Management Interventions for Patients with a Primary Headache Disorder: A Systematic Review of Randomized Controlled Trials

Amy Noser ¹, Robert Gibler ¹, Rachelle Ramsey ¹, Rebecca Wells ², Elizabeth Seng ³, Kevin Hommel ⁴

PMCID: PMC10336649 NIHMSID: NIHMS1837109 PMID: 36286601

Abstract

Objective:

To systematically review the empirical literature examining the efficacy of digital headache management interventions for patients with a primary headache disorder.

Background:

Digital headache management interventions provide opportunities to improve access to behavioral headache interventions to underserved groups.

Methods:

A systematic search of PubMed, Scopus, and EBSCO (PsycInfo, Education Research Complete, ERIC, Health Source: Nursing/Academic Edition, Psychology and Behavioral Sciences Collection) and reference review was conducted. Included studies had to recruit a sample with a primary headache diagnosis, be a randomized controlled trial including a digital component, assess a headache outcome (i.e., frequency, duration, severity, intensity, disability) or quality of life, and be published in English. Two authors independently extracted data for included studies. The methodological quality of studies was assessed using the Revised Cochrane Risk-of-Bias Tool.

Results:

Thirteen studies with unique interventions met inclusion criteria. Over half of the studies were pilot, however nearly 70% (9/13) demonstrated significant between-group or within-group improvements on one or more headache-related outcomes. All interventions included some form of relaxation training and the majority were delivered via interactive website. While less than half the studies report participant race and/or ethnicity, of those that do, 83% (5/6) reported a predominately White/Caucasian sample.

Conclusions:

Efficacy testing of digital headache interventions is in its infancy with the majority of these studies relying on pilot studies with small samples comprised of homogenous patient populations. Interactive websites were the most common digital medium to deliver digital headache management interventions and have demonstrated promising results. Further testing using large scale randomized controlled trials and exploration of other digital tools is warranted. Future studies with more diverse samples are needed to inform health equity of digital headache interventions.

Keywords: migraine, headache, self-management, technology, electronic health, mobile health

Primary headache and migraine are prevalent chronic conditions,¹ with migraine itself affecting approximately 15% of adults^{2, 3} and between 8%−23% of children and adolescents.^{4, 5} In order to target all aspects of headache (frequency, duration, severity, and disability), effective treatment requires a multimodal approach including pharmacological therapy, biobehavioral interventions, and adherence to healthy lifestyle habits.^6–9 Although in-person behavioral interventions improve treatment adherence, disease management, and health outcomes among patients with headache and migraine,^10–12 these services are typically only available in multidisciplinary tertiary care settings,^13–15 whereas at least two thirds of primary headache and migraine concerns are seen in primary care settings.^{14, 16, 17} Additionally, many patients encounter barriers accessing treatment services as well as effectively translating skills learned in clinic into their daily routines across various environmental settings (e.g., home, work, and school settings).¹⁸ These barriers are particularly prevalent among individuals from racially and ethnically minoritized groups, yet they have been largely underrepresented in headache research, to date.^{19, 20}

Digital interventions and tools provide an opportunity for overcoming many of these barriers to accessing health interventions. Over the last decade, use of digital platforms such as smartphones apps, video conferencing, interactive websites, and text-messaging, have been used to deliver headache management interventions in order to help transcend barriers of traditional in-person behavioral interventions by allowing patients to access care when and where they need it.^21–23 Digital platforms offer opportunities to provide headache interventions that are more accessible than in-person behavioral headache care and if shown to be efficacious, could be prescribed by a health care provider.²⁴ Digital health interventions and tools may also be more cost-effective, although issues related to insurance reimbursement may interfere with implementation in certain settings. Digital health tools are certainly more customizable to individual patient preferences and treatment goals than static handouts commonly used in doctors’ offices to disseminate headache self-management information.^25–29 Patients with migraine, in particular, have expressed preferences for use of digital platforms for intervention delivery^{28, 29} and digital tools (e.g., apps) to support adherence to their headache regimen.^{25, 27} Moreover, the COVID-19 pandemic has necessitated the increased use of technology in health care, and telehealth is increasingly considered an acceptable treatment modality for patients with headaches and their providers.³⁰

Despite rapid development and patient preferences for digital headache interventions, there is an absence of specific outcomes data on the efficacy of technology interventions on headache outcomes and quality of life (QOL). Recent reviews of the digital headache literature have largely focused on the availability, feasibility, and acceptability of digital headache technologies for adult and pediatric populations.^{21–23, 31, 32} In addition, many of these reviews have not taken a systematic approach,^{22, 23} nor has the primary intent focused on the outcomes of randomized controlled trials (RCTs).^{21–23, 31, 32} To extend our understanding beyond previous reviews, we systematically reviewed RCTs of digital interventions designed for patients with a primary headache disorder.

For the current review, we specified Population, Intervention, Comparison, and Outcome (PICO) criteria to assess the available evidence of digital headache management interventions for improving health outcomes and QOL. Specific PICO criteria included: pediatric and adult patients with a primary headache disorder (P); use of a digital headache management intervention (I); compared to another treatment or treatment as usual (TAU) (C), and assessment of change in health outcomes (i.e., headache frequency, duration, severity, intensity, and disability) or QOL (O). For our review, a digital health intervention was defined as any study where some component of the headache intervention was delivered via a digital platform (e.g., website, mobile phone, CD-ROM, wearables, and biofeedback devices). Studies that included a digital assessment component (e.g., electronic headache diary) but did not include a digital intervention component were excluded. The study aims to: (1) evaluate the overall efficacy of digital headache management interventions on health outcomes (i.e., headache frequency, duration, severity, intensity, disability) and QOL, and (2) examine intervention components and digital mediums used in these interventions.

Method

Data Search.

A protocol was developed a priori in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) standards³³ and used to guide the systematic review process. The protocol used was not registered in a database prior to conducting the review, but is available by request. The search examined the PubMed, Scopus, and EBSCO (PsycInfo, Education Research Complete, ERIC, Health Source: Nursing/Academic Edition, Psychology and Behavioral Sciences Collection) databases. The specific search strategies are included in the Supplemental Materials. The initial search was conducted in May 2021 and limited articles to those that focused on humans and were published in English. No restrictions were placed on publication date. Database searches were supplemented with manual searches of reference lists for relevant review articles. To be included in the review, each study had to meet the following criteria: (1) conducted in a pediatric or adult sample with participants meeting criteria for a primary headache diagnosis; (2) included an RCT with a digital intervention component; (3) examined a headache outcome (i.e., frequency, duration, severity, intensity, disability) or QOL as a primary or secondary outcome; (4) published in English; (5) published in peer-reviewed journal; and (6) utilized a digital platform (e.g., website, mobile phone, CD-ROM, wearables, and biofeedback devices) to deliver ≥ 1 component of the psychological, behavioral or educational intervention or treatment. Studies that used a digital assessment component (e.g., electronic diary) but did not include a digital intervention were excluded.

Article Selection.

Article titles and abstracts were aggregated in an EndNote library. Initial manual reviews of abstracts and titles were completed by the first and second authors (A.N. and R.G.). If criteria were not evident from the title or abstract review, the article was included for full-text review. The authors then independently reviewed the full-text articles, and the final inclusions were reviewed and finalized by the first, second, and senior author (A.N., R.G., and K.H.) to ensure all criteria were met. The author of one included study was contacted to confirm whether all study participants met criteria for a primary headache diagnosis.³⁴

Data Extraction.

For each article, sample size, patient population, demographic characteristics, length of intervention, intervention components, digital medium, drop-out rates, headache-specific outcomes, QOL outcomes, and additional psychosocial outcomes were independently extracted by two authors (A.N. and R.G.) and discrepancies were resolved through discussion until consensus was reached. The report of intervention components account for both digital and in-person aspects of the intervention. Data extraction and summarization was completed in Microsoft Excel.

Quality Assessment.

Two authors (A.N. and R.G.) independently assessed the methodological quality of included studies using the Revised Cochrane Risk-of-Bias Tool for Randomized Trials.³⁵ Studies were assessed on the following criteria: randomization process, deviations from the intended interventions (e.g., masking of study participants and treatment administrators), missing outcome data, measurement of outcome, and selection of the reported result. Each trial was graded as Low Risk, Some Concerns, or High Risk for each of these criteria and also given an overall rating. Authors resolved discrepancies in ratings through discussion until consensus was achieved.

Authors also evaluated study size based on the Cochrane Pain, Palliative, and Supportive Care Review Group recommendations for assessing the risk associated with the sample size of the study.³⁶ These criteria include: Low Risk-of-Bias (≥ 200 participants per treatment arm); Unclear Risk-of-Bias (50 – 199 participants per treatment arm); and High Risk-of-Bias (< 50 participants per treatment arm).

Analysis.

Descriptive statistics were calculated (frequency counts and percentages) to describe and summarize the sample characteristics and intervention components of the included studies. All analyses were conducted in Microsoft Excel 2013.

Results

A total of 14 articles met inclusion criteria for the review (Figure 1), which represented 13 studies (the results from 2 of the articles were combined and reported as 1 study because they used data from the same sample at different time points).^{37, 38} The details of the included studies are presented in Table 1. Seven studies were conducted in adult samples and 6 in pediatric samples. Most studies included a predominately female sample. Seven studies (n = 7/13; 54%) did not report racial/ethnic composition of the sample.^37–43 Across studies that reported the racial/ethnic composition of the sample (n = 6),^{34, 44–47} White/Caucasian participants comprised 45–94% of the study samples with two-thirds of these studies (n = 4) including a sample that was > 75% White/Caucasian.^{34, 44, 45, 47} Diagnosis of a primary headache disorder was an inclusion criteria for all studies with 69% (9/13) of these studies focusing exclusively on patients with migraine.^{34, 37, 40, 41, 44, 46–49} Ten studies indicated that participants’ headache diagnosis was based on the International Classification of Headache Disorders (ICHD) criteria,^{34, 37, 40, 41, 44–49} 2 studies relied on a physician-confirmed diagnosis,^{39, 43} and 1 study provided no additional information beyond a description of their study sample (i.e., patients with migraine and/or tension-type headache).⁴²

Table 1.

Characteristics of included studies

Reference	n	Age Mean (Range) (yrs)	Demographics	Digital Intervention	Intervention Components	Between-Group Headache Outcomes	Within-Group Headache Outcomes	Additional outcomes
Bromberg et al., 2012⁴⁴	189	42.6^A (20–66)	89.2% Female 87.5% White; 4.89% Black/African American; 2.17% Asian American; 2.17% Hispanic/Latino; 0.54% Native Hawaiian/other Pacific Islander	Interactive website (painACTION) with 5 core modules: (1) migraine-specific knowledge; (2) migraine self-management skills; (3) emotional coping; (4) communication skills; and (5) medication safety; content delivered via lessons, tools, self-assessments, and user-generated content (text, audio, video)	B; E; R	No statistically significant between-group difference in migraine-related disability pre-post intervention	Both intervention and control groups experienced similar, though non-statistically significant, reductions in migraine-related disability	Locus of control^* Pain catastrophizing^* Psychological distress^* Positive coping strategies^* Self-efficacy^* Depression^* Stress^* Anxiety
Connelly et al., 2006⁴⁵	37	10.0^P (7–12)	51.3% Female 86% White; 8% Hispanic; 3% African American; 3% Asian	Headstrong CD-ROM intervention which included several modules relevant to headache management including headache education, relaxation training, cognitive coping skills, and problem solving	B; E; C; R	Statistically significant reductions in caregiver- and child-reported headache frequency, duration, and intensity as well as child-reported headache severity in the treatment group No statistically significant between-group differences in caregiver- and child-reported headache-related disability or caregiver-reported severity	No statistically significant within-group changes in headache-related disability at post-intervention or 1 month follow-up	--
Devineni et al., 2005³⁹	139	41.0^A	79.9% Female Racial/ethnic composition of sample not reported	Internet-delivered behavioral intervention that includes progressive muscle relaxation, biofeedback, and stress management + therapist phone support	B; E; C; R	Statistically significant improvement in headache-related disability in the treatment group	--	Depression Trait anxiety
Hedborg & Muhr, 2011⁴⁰	83	47.8^A (22–65)	69.9% Female Racial/ethnic composition of sample not reported	2 treatment arms: • Multimodal behavioral treatment delivered via internet • Multimodal behavioral treatment delivered via internet + single in-person hand massage training session	B; E; C; R	Statistically significant higher proportion of participants in both treatment groups showed clinically significant improvement in headache frequency (i.e., ≥ 50% reduction) compared to the control group Statistically significant improvement in QOL perceived work performance in both treatment groups at 8-month assessment	Statistically significant within-group improvement in QOL perceived work performance for the multimodal behavioral treatment + hand massage treatment group at all time-points	Depression
Kleiboer et al., 2014³⁷ Sorbi et al., 2015³⁸	368	43.6^A	85.0% Female Racial/ethnic composition of sample not reported	Behavioral treatment protocol adapted for delivery through internet portal; 8 lessons including relaxation training, self-management skills, and skill application + therapist support via email (weekly or biweekly based on patient preferences)	B; E; C; R	No significant between-group differences in headache frequency, intensity, disability, or QOL at post-intervention or 6-month follow-up or headache severity at post-intervention	Statistically significant within-group reductions in headache intensity and severity in the treatment arm only; reduction in headache intensity maintained through 6-month follow-up Statistically significant within-group decline in QOL at post-intervention and improvement at 6-month follow-up in the control group only Both intervention and control groups experienced statistically significant, reductions in migraine attack frequency	Migraine-related self-efficacy^* External locus of control^* Internal locus of control^*
Minen et al., 2020⁴⁶	169	41.7^A (21–73)	83.5% Female 27.3% Hispanic or Latino 53.9% White; 20.8% Unknown/Other; 18.7% Black/African American; 6.4% Asian or Pacific Islander	RELAXaHEAD smartphone app, which includes an electronic headache diary; intervention group received a version of the app that contains a progressive muscle relaxation (PMR) component	B; R	No significant between-group differences on migraine-related disability at post-intervention or 3-month follow-up	Greater, though non-statistically significant, decline in migraine-related disability in treatment group	--
Minen et al., 2020⁴⁸	62	39.5 (18–80)^A	89.0% Female 34% Hispanic or Latino 45.0% White; 31.0% Black/African American; 23.0% “other races”; 2.0% unknown	RELAXaHEAD smartphone app, which includes an electronic headache diary; intervention group received a version of the app that contains a progressive muscle relaxation (PMR) component	B; R	No significant between-group differences in migraine-related disability or QOL	--	--
Minen et al., 2021⁴⁷	52	42.2^A	88.5% Female 3.8% Hispanic or Latino 78.8% White 21.2% “Non-White”	App-based heart rate variability (HRV) biofeedback (Heartmath)	E; R	No significant between-group differences on migraine-related disability or QOL	“	Anxiety Depression Insomnia
Rapoff et al., 2014³⁴	35	10.2^P (7–12)	71.4% Female 94.3% Caucasian/White; remainder of sample not described	Self-guided CD-ROM program including cognitive-behavioral self-management strategies including guided imagery, deep breathing, and progressive muscle relaxation, problem solving, stress management, pain behavior and parental responses to pain	B; E; C; R	Statistically significant improvement in child-reported headache severity in the treatment group at post-intervention and caregiver-reported migraine-related disability at 3-month follow-up No statistically significant between-group differences in caregiver- and child-reported headache frequency, duration, or QOL at post-intervention or follow-up, caregiver-reported migraine-related disability at post-intervention, or child-reported headache severity at follow-up	--	--
Scharff et al., 2002⁴⁹	36	12.8^P (7–17)	66.7% Female Racial/ethnic composition of sample not reported	Four in-person session of multimodal behavioral treatment + biofeedback with a supplemental portable biofeedback device for home practice 2 control arms: • Four in-person session of biofeedback focused on hand cooling strategies • Waitlist control	B; E; C; R	No statistically significant between-group differences in headache frequency or intensity	Statistically significant within-group decline in headache frequency and intensity in treatment and control groups ^Ʈ	Depression State and trait anxiety
Stubberud et al., 2021⁴¹	16	14.8^P (12–18)	68.8% Female Racial/ethnic composition of sample not reported	Self-administered treatment app including biofeedback training and a headache diary	B; R	No statistically significant between-group difference in headache frequency, intensity, or disability	No statistically significant within-group changes in headache frequency, intensity, or disability^Ŧ	--
Trautman & Kröner-Herwig, 2008⁴²	18	13.4^P (10–18)	Gender and racial/ethnic composition of sample not reported	Six Internet-delivered self-help treatment sessions + weekly online chat support from a therapist	B; E; C; R	No statistically significant between-group difference in headache frequency, duration, or intensity	Statistically significant within-group decline in headache frequency in the treatment group only No within-group changes in headache duration or intensity	Pain catastrophizing^*
Trautman & Kröner-Herwig, 2010⁴³	68	12.7^P (10–18)	55.3% Female Racial/ethnic composition of sample not reported	2 treatment arms: • 6-session multimodal cognitive-behavioral training delivered via internet + weekly therapist support via email or phone • Applied relaxation training delivered via internet + weekly therapist support via email or phone	B; E; C; R	No significant between-group differences in headache frequency, duration, or intensity or QOL Statistically significant higher proportion of participants in the cognitive-behavioral treatment group showed clinically significant improvement in headache frequency (i.e., ≥ 50% reduction) compared to the control group	Statistically significant decline in headache frequency and duration in treatment and control groups No within-group changes in headache intensity or QOL	Pain catastrophizing Depression

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Significant differences between intervention group compared to control Notes. Years – yrs;

– adult sample;

– pediatric sample; B – behavioral; E – education; C – cognitive-behavioral; R – relaxation training; -- unavailable; not reported in article; quality of life – QOL; -- – indicates data not assessed or available for a study;

^Ʈ

3-, 6-, & 12-month follow-ups are not reported because hand-warming and hand-cooling groups were combined after hand-cooling group completed hand-warming training;

^Ŧ

Within-group differences were only examined in the treatment group

Intervention characteristics

The 13 included studies detailed 11 unique interventions, as overlap occurred: 2 interventions were tested in more than 1 study using independent samples,^{34, 45, 46, 48} 3 studies included more than two arms,^{40, 43, 49} and 1 of these studies⁴³ used an intervention tested in another study included in this review.⁴² Interventions included between 2 and 4 components, with relaxation training (n = 11/11; 100%) being the most commonly used component followed by behavioral strategies (e.g., self-monitoring, feedback on treatment progress; n = 10/11; 91%), psychoeducation (n = 9/11; 81%), and cognitive-behavioral therapy (CBT; n = 7/11; 64%). Interventions lasted between 1 month and 6 months, with the majority (n = 9/11; 82%) of interventions lasting between 1 and 3 months. Nine studies (n = 9/13; 69%) included post-intervention follow-up assessments. While all studies were RCTs, over half reported that they were pilot studies (n = 7/13; 54%) and thus, the relatively small sample sizes may have limited their ability to detect differences between treatment and control groups.

Seven interventions were compared to a control condition that used a digital component, including an electronic headache diary (n = 3),^{37–39, 46, 48} a website providing headache education along with therapist communication (n = 2),^{42, 43} an app using a headache diary and sham biofeedback,⁴¹ or a CD-ROM teaching relaxation strategies (n = 1).⁴⁰ One intervention tested in two separate samples included a TAU plus paper headache diary control group in one study⁴⁵ and a CD-ROM with headache education control group in another study.³⁴ One intervention compared treatment to an active control (i.e., hand-cooling biofeedback) and a waitlist control that maintained headache diaries.⁴⁹ Two interventions were compared to TAU.^{44, 47}

Intervention digital medium.

Five interventions used a self-directed digital medium, indicating that a health care provider was not necessary for intervention delivery.^{34, 41, 44–48} Four of the 5 interventions used an interactive website or mobile health (mHealth) app. One intervention tested in two separate samples used an mHealth app to provide training on use of progressive muscle relaxation (PMR) along with a headache diary for symptom monitoring.^{46, 48} Two interventions used an mHealth app as a platform to provide biofeedback^{41, 47} with one of these apps also including a headache diary.⁴¹ One intervention used an interactive website with modules on migraine specific psychoeducation, self-management (e.g., self-monitoring, relaxation training), coping (e.g., managing migraine-related anxiety and negative thinking), communication skills (e.g., effective patient-provider communication), and medication safety.⁴⁴ One intervention that was tested in 2 separate study samples used an interactive CD-ROM intervention that included modules on headache psychoeducation, relaxation training, cognitive coping skills, and problem-solving.^{34, 45}

Five interventions used a combination of digital technology and interactions with a health care provider to deliver the intervention.^{37–40, 42, 43} All five of these interventions included the use of an interactive website to provide a multicomponent headache management intervention (e.g., psychoeducation, relaxation training, coping training, and use of behavioral strategies) using a multimodal approach (e.g., use of videos, interactive exercises, audio recordings, and text). In four of these studies, the interactive website was coupled with weekly or biweekly phone, email, or instant messaging sessions with a health care provider to provide support with completion of the web-based intervention (e.g., reminders, encouragement, and feedback about completion of intervention modules).^{37–39, 42, 43} One study used an interactive website along with a single in-person session to teach participants hand massage techniques.⁴⁰

One study used digital technology to supplement in-person treatment intervention.⁴⁹ In this study, a portable biofeedback device was used to support home practice of relaxation strategies taught during a clinic-based CBT and stress-management intervention.

Intervention outcomes.

Frequency.

Between-group differences in headache frequency was assessed in 8 of the 13 studies (69%).^{34, 37, 38, 41–43, 45, 46, 49} Specifically, Connelly et al. used an interactive CD-ROM intervention and demonstrated a significant decline in headache frequency in the treatment arm compared to the control arm at post-intervention.⁴⁵ Seven studies demonstrated no significant between-group changes in headache frequency,^{34, 37, 38, 41–43, 46, 49} with 1 study also showing no change at 3-month follow-up.³⁴ Five studies examined within-group differences in headache frequency.^{37, 38, 42, 43, 49} Trautmann and Kröner-Herwig included use of an interactive website plus therapist support and was the only study that demonstrated a significant decline in headache frequency from pre- to post-intervention in the treatment arm only, which was maintained through 6-month follow-up.⁴² Stubberud et al. examined within-group difference in the treatment group only and found no within-group change at 4-week or 8-week assessment points.⁴¹ The remaining 3 studies all demonstrated a significant decline in headache frequency in both the treatment and control arms from pre- to post-intervention^{37, 38, 43, 49} with 2 of these studies demonstrating that these effects were maintained at 6-month follow-up.^{37, 38, 43} Five studies assessed clinically significant improvement, defined as a ≥ 50% reduction in headache frequency. Clinically significant improvement was demonstrated for 29% to 63% of participants randomized to study intervention arms and 13% to 39% of participants in control arms.^{37, 38, 40–43} Hedborg and Muhr used an interactive website along with a single in-person hand massage training session and found that a significantly higher proportion of participants in both treatment arms demonstrated clinically significant improvements compared to the control arm.⁴⁰ Trautmann and Kröner-Herwig found that a significantly higher proportion of participants in their cognitive-behavioral treatment group showed clinically significant improvement in headache frequency compared to the control group.⁴³

Duration.

Headache duration was assessed in 4 of the 13 studies (31%).^{34, 42, 43, 45} Connelly et al. included an interactive CD-ROM intervention and found that caregiver- and child-reported headache duration were significantly lower in the treatment arm compared to the control arm at post-intervention.⁴⁵ Three studies found no differences in headache duration between the treatment and control groups at post-intervention^{34, 42, 43} or at 3-month follow-up.³⁴ Two studies both using an interactive website plus communication with a therapist examined within-group differences in headache duration.^{42, 43} Findings from a pilot RCT conducted by Trautmann and Kröner-Herwig showed no within-group change in headache duration in either the intervention or control arms at post-intervention or 6-month follow-up.⁴² Results of another RCT conducted by Trautmann and Kröner-Herwig demonstrated significant within-group declines in headache duration in both the intervention and control arms, which was maintained at 6-month follow-up.⁴³

Severity.

Headache severity was assessed in 3 of the 13 studies (23%).^{34, 37, 45} Specifically, Connelly et al. and Rapoff et al. tested the same interactive CD-ROM intervention and both demonstrated a significant decline in child-reported but not caregiver-reported headache severity in the treatment arm compared to the control arm at post-intervention,^{34, 45} however this difference was not maintained at 3-month follow-up.³⁴ Kleiboer et al. tested an intervention using an interactive website plus therapist support and demonstrated no difference in headache severity between the treatment and control arms; however, only the treatment arm showed a significant within-group decline in headache severity from pre- to post-intervention.³⁷ No other studies examined within-group changes in headache severity.

Intensity.

Headache intensity was assessed in 5 of the 13 studies (38%) and none of these studies demonstrated between-group differences.^{37, 38, 41–43, 49} Five studies examined within-group differences in headache intensity.^{37, 38, 41–43, 49} Kleiboer et al. used an interactive website along with therapist support and found a significant decline in headache intensity from pre- to post-intervention in the treatment arm only³⁷ which was maintained through 6-month follow-up.³⁸ Scharff et al. included use of a portable biofeedback device to support in-person treatment sessions and showed a significant decline in headache intensity in the treatment and control arms.⁴⁹ Three studies found no change in headache intensity for either the treatment or control arms.^41–43

Disability.

Headache disability was assessed in 9 of the 13 studies (69%).^{34, 37, 39, 41, 44–48} Specifically, Devineni et al. used an interactive website with therapist support and demonstrated a significant decline in headache disability in the treatment arm compared to the control arm at post-intervention.³⁹ Rapoff et al. implemented an interactive CD-ROM intervention and demonstrated no between-group differences in caregiver- or child-reported headache disability at post-intervention.³⁴ However, this study found that the caregiver-reported but not child-reported headache disability significantly improved in the treatment arm compared to the control arm at 3-month follow-up.³⁴ Seven studies found no significant difference in headache disability between the treatment and control arms.^{37, 41, 44–48} Four studies assessed within-group differences in headache disability.^{37, 38, 41, 45, 46} Kleiboer et al. included an interactive website along with therapist support and demonstrated significant improvement in headache disability in both the treatment and control arms at post-intervention³⁷ which was maintained through 6-month follow-up.³⁸ Three studies found no significant change in either the treatment or control arms at post-intervention^{41, 45, 46} or 3-month follow-up.^{45, 46}

Quality of Life.

Quality of life was assessed in 6 of the 13 studies (46%).^{34, 37, 38, 40, 43, 47, 48} Hedborg and Muhr included an interactive website and a single in-person session to teach hand massage techniques and demonstrated a significant improvement in QOL related to individuals’ perceived work performance in the 2 treatment arms compared to the control group at the 8-month assesement.⁴⁰ Kleiboer et al. used an interactive website and therapist support and demonstrated marginal improvements in QOL in the treatment arm compared to the control arm at 6-month follow-up.^{37, 38} Four studies demonstrated no between-group differences in QOL.^{34, 43, 47, 48} Four studies assessed within-group differences in QOL.^{37, 38, 40, 43, 47} Hedborg and Muhr demonstrated significant improvement on the QOL related to perceived work performance in one treatment arm (i.e., behavior treatment + hand massage group) but not the other treatment arm (i.e., behavior treatment) or control arm at the 5-month and 8-month assessment points.⁴⁰ Kleiboer et al. demonstrated a significant decline in QOL in the control arm at post-intervention³⁷ and a significant improvement in QOL in the treatment arm at 6-month follow-up.^{37, 38} Three studies demonstrated no within-groups differences in QOL.^{34, 43, 47}

Study Quality.

Revised Cochrane Risk-of-Bias.

Table 2 reports the results of the risk-of-bias analysis. The majority of studies were rated as having some concerns (85%; 11/13) in the randomization process with the remaining studies rated as low risk (15%; 2/13). All studies were rated as low risk on deviations from intended interventions (100%; 13/13). Over half of the studies (62%; 8/13) were rated as high risk on the assessment of missing outcome data and 31% (4/13) and 8% (1/13) were rated as having some concerns or low risk, respectively. Nearly all of the studies were rated as having some concerns (92%; 12/13) on the measurement of outcomes with the one remaining study rated as low risk (8%; 1/13). All studies were rated as having some concerns on the selection of the reported results (100%; 13/13).

Table 2.

Revised Cochrane Risk-of-Bias assessments for all included studies

Studies	Randomization Process	Deviations from Intended Interventions (assignment)	Missing Outcome Data	Measurement of Outcomes	Selection of the Reported Results	Overall ROB
Bromberg et al., 2012⁴⁴	SC	LR	HR	SC	SC	HR
Connelly et al., 2006⁴⁵	SC	LR	SC	SC	SC	SC
Devineni et al., 2005³⁹	SC	LR	HR	SC	SC	HR
Hedborg & Muhr, 2011⁴⁰	SC	LR	SC	SC	SC	SC
Kleiboer et al., 2014³⁷	LR	LR	HR	SC	SC	HR
Minen et al., 2020a⁴⁶	SC	LR	HR	SC	SC	HR
Minen et al., 2020b⁴⁸	SC	LR	HR	SC	SC	HR
Minen et al., 2021⁴⁷	SC	LR	LR	SC	SC	SC
Rapoff et al., 2014³⁴	SC	LR	HR	SC	SC	HR
Scharff et al., 2002⁴⁹	SC	LR	SC	SC	SC	SC
Stubberud et al., 2021⁴¹	LR	LR	HR	LR	SC	HR
Trautman & Kroner-Herwig, 2008⁴²	SC	LR	SC	SC	SC	SC
Trautman & Kroner-Herwig, 2010⁴³	SC	LR	HR	SC	SC	HR

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Note. Low Risk- LR; Some Concerns – SC; High Rick - HR

Sample Size.

Assessment of risk associated with the sample size demonstrated that 77% of studies were rated as High Risk-of-Bias (10/13) and 23% of studies showed an Unclear Risk-of-Bias.

Discussion

In this systematic review, we examined the efficacy of headache management digital tools on several headache outcomes, including QOL, headache frequency, severity, and disability. Our results build upon previous reviews demonstrating support for the feasibility, acceptability, and initial efficacy of mobile and eHealth platforms for treating headache disorders^21,22,31 and provide a summary of efficacy data from RCTs that tested a digital intervention. We found that nearly 70% of the included digital interventions yielded significant between-group or within-group improvements on one or more headache outcome or QOL. Over half of the studies that demonstrated between-group differences were conducted in an adult sample and used an interactive website with some form of therapist support. These studies showed clinically significant improvement in headache frequency (i.e., ≥ 50% reduction),^{40, 43} headache-related disability,³⁹ or QOL⁴⁰ in the treatment arm compared to the control arm. The 2 remaining studies that demonstrated between-groups differences tested the same multicomponent CD-ROM intervention in two separate pediatric samples.^{34, 45} These two studies demonstrated significant improvement on caregiver- and child-reported headache frequency,⁴⁵ duration,⁴⁵ and intensity,⁴⁵ as well as child-reported headache severity at post-intervention,^{34, 45} and caregiver-reported migraine-related disability at 3-month post-intervention.³⁴ Of the studies reporting significant within-group differences on headache outcomes or QOL, the majority found these differences occurred in both the treatment and control groups. However, it is noteworthy that 2 studies using an interactive website with therapist support demonstrated improvement in the treatment group only.^{37, 42} Several studies demonstrated additional significant improvements in psychosocial outcomes such as pain catastrophizing, self-efficacy, and locus of control.

Consistent with findings from reviews by Minen and colleagues²³ and van de Graaf et al.²¹, the digital interventions reviewed in this systematic review included some form of relaxation training and the majority incorporated behavioral strategies. However, the specific characteristics, components, and delivery mediums varied across interventions. In line with previous systematic reviews and meta-analyses of headache interventions demonstrating that multicomponent interventions may be most effective,^50–53 all of the included digital interventions used multiple components. Digital mediums and characteristics varied across studies and included interactive websites, mHealth apps, CD-ROMs, electronic self-monitoring diaries, personalized messages, automated reminders, and biofeedback devices. Interactive websites were the most common digital medium used for intervention delivery^{37, 39, 40, 42–44} with the majority of these interventions being adopted from an existing face-to-face intervention^{37–39, 42, 43} and including some interaction with a therapist.^{37–40, 42, 43} Findings from these studies suggest that multicomponent headache management interventions can be successfully translated for use on digital mediums and provide opportunities to learn and practice evidence-based techniques such as relaxation strategies (e.g., diaphragmatic breathing, PMR), behavioral strategies (e.g., self-monitoring of symptoms, triggers, and treatment adherence), and education (e.g., informational videos). Overall, results support the promise of these digital interventions in facilitating positive improvements for important clinical outcomes such as headache days.

Just over half of the included interventions use a digital intervention supplemented by interactions with a health care provider (e.g., interactive website supplemented by either weekly instant messaging discussion with a therapist or a single in-person skills session)^{37, 39, 40, 42, 43} or use a digital technology as an adjunct to a clinic-based intervention (e.g., in-person CBT and relaxation training supplemented with a portable biofeedback device for home practice).⁴⁹ Based on the studies included in this review, it is unclear if contact with a health care provider directly impacts intervention efficacy, or if it indirectly impacts outcomes through promoting intervention engagement. While it is plausible that health care provider involvement could lead to increased engagement and improved therapeutic alliance, which, in turn, may lead to better treatment outcomes, self-directed digital interventions are likely more cost-effective and sustainable. Considering that both self-directed and combination digital interventions demonstrated positive headache outcomes, future studies are needed to assess the benefits of including contact with health care providers in headache management interventions. Additionally, given the multicomponent nature of headache interventions and the need to streamline resource intensive and high cost components (e.g., health care provider interactions), future studies should also seek to optimize digital headache interventions by dismantling and testing the empirical performance of individual and sets of intervention components to determine the most efficient and cost-effective interventions options.^{18, 54}

As displayed in Table 2, nearly all studies included in this review were identified as having some concerns or a high risk-of-bias due to a small sample size or missing outcome data. Future trials with adequate sample sizes and low attrition are needed to determine the efficacy of digital headache interventions. In addition, the majority of included studies were rated as having some concerns due to unavailable information regarding pre-registration of data analytic plans or the open-label nature of many trials (i.e., participants or investigators not masked to treatment condition). While double-masking in clinical trials increases confidence in the validity of study results, this type of methodological rigor may not be possible or feasible in some trials of digital interventions, particularly if the control condition does not include some type of digital medium. For example, double-masking would not be possible in a trial in which participants were randomized to receive either a digital intervention or remain in usual care (e.g., Bromberg et al., 2012⁴¹), as participants would have naturally been aware about whether they received the experimental treatment or did not. As this field of clinical research continues to grow, future trials of digital interventions should incorporate gold-standard methodological strategies, such as ensuring masking of participants and investigators to treatment allocation, to increase confidence in trial findings.

Less than half of the included studies report on participant race and/or ethnicity, with nearly all of these studies reporting recruitment of a predominately White/Caucasian sample.^{34, 44–47} Thus, results of this review at best suggests that digital headache interventions demonstrate initial efficacy for use in a White/Caucasian sample. It is unclear if the non-diverse samples were due to limited recruitment strategies across diverse populations or if it reflects preferences. Further, while it is possible that those studies not reporting the racial/ethnic makeup of their sample were more diverse, none of the included studies mention use of culturally informed approaches in intervention development or implementation. These findings are concerning, given that digital technologies and interventions are often considered an opportunity to mitigate health disparities of racially and ethnically minoritized groups.^{55, 56} Thus, future studies that seek to develop and evaluate digital headache interventions should be designed in a manner that will overcome, rather than perpetuate, health disparities. This line of research is necessary to help ensure that digital technologies and tools increase access to care for individuals and families impacted by systemic racism through means such as providing remote options for treatment, reducing cost of care, minimizing transportation challenges, and providing care in a private and destigmatizing environment.^55–57

In order to achieve these goals, digital headache interventions must directly address digital inequalities, which include not only differences in access to technology but also digital literacy (i.e., motivation and competence to access and obtain benefits from use of digital technologies).^55–57 These factors span a multidimensional continuum and directly align with social determinants of health (e.g., socioeconomic status, health literacy).^55–57 Existing research has documented similar disparities in health technologies for other chronic and mental health conditions, and has provided recommendations on how to mitigate this in digital intervention design and implementation.⁵⁶ First, the need for development of digital tools that carefully consider the needs of Black, Indigenous, and people of color is emphasized. Specifically, this recommendation highlights the importance of using human-centered design processes that involve the end user throughout product development and testing to ensure that the type and way a digital tool is utilized meets the specific needs and capabilities of the user.⁵⁶ Reliance on human-centered design approaches that effectively mitigate health disparities will require engaging patients and families whose voices are traditionally underrepresented in health care settings to understand barriers to receiving effective behavioral health care and the role of technology in overcoming these barriers.⁵⁶ Researchers should also identify approaches to expand recruitment strategies to ensure inclusion of diverse patient populations. Another key recommendation includes leveraging novel methodologies (e.g., multiphase optimization strategy and sequential, multiple assignment, randomized trials^{54, 58}) to develop adaptive digital interventions that modify the type, dose, or timing of an intervention based on individual patient characteristics and treatment response. Advantages of these intervention designs include the ability to tailor the type, dose, or timing of an intervention based on baseline patient characteristics (e.g., race, sexual identity, health literacy, family structure) and time-varying factors (e.g., external stressors, disease flare).

It is notable that nearly all interventions used an active control condition that included a digital component (e.g., electronic headache diary, website or app with psychoeducation), making it challenging to parse out specific benefits attributed to the exclusive use of digital tools. Additionally, nearly two-thirds of the included studies were pilot randomized trails, and variability in the headache outcomes assessed did not allow for a quantitative evaluation of the studies (e.g., meta-analysis), which limits the conclusions that can be drawn from the findings of the review. Therefore, this review relied on the PRISMA guidelines to provide a comprehensive review of digital headache intervention efficacy along with the components, characteristics, and delivery.³³ Future studies should consider conducting a meta-analysis and/or formal quantitative synthesis when more large-scale efficacy trials have been conducted.

Patient preferences for use of digital technologies to promote headache management indicate a need for health care providers to consider recommending digital tools that may benefit patients in the context of clinical care.^{25, 27–29} Despite the need for larger RCTs and development testing of culturally-informed digital headache tools, the present literature suggests that self-directed digital interventions and combination digital and in-person interventions are promising. Patients may benefit from a referral for headache management interventions that combine digital technologies with health care provider interactions or recommendations for self-directed digital headache interventions, which may be a more feasible approach in busy clinic settings. Although, efficacy testing has only been carried out in a few headache management apps,^{41, 47, 48} ratings of headache management apps for inclusion of evidence-based behavioral strategies and relaxation training are available⁵⁹ and provide a starting point for “prescribing” headache digital interventions and tools for patients and families.

Conclusion

This systematic review sought to evaluate the existing literature examining digital interventions that aim to improve headache outcomes and QOL in pediatric and adult populations with a primary headache disorder, and to highlight specific components of effective headache management interventions that can be integrated into future research and clinical care. Efficacy testing of digital headache interventions, although largely reliant on open-label studies and pilot trials with small sample sizes, have demonstrated promising results.^{37, 39, 40, 42–44} Most digital interventions included relaxation training and behavioral strategies (e.g., self-monitoring, feedback on treatment progress). However, further testing using large scale RCTs high methodological rigor as well as exploration of other digital tools (e.g., apps) for intervention delivery is warranted. Additionally, to ensure that digital health interventions are developed with a goal to increase health equity, future studies should rely on human-centered design approaches, engage patients and families from racially and ethnically diverse groups in the development process, and leverage novel methodologies for developing digital tools and interventions.

Supplementary Material

Supinfo

NIHMS1837109-supplement-Supinfo.docx^{(13.8KB, docx)}

Funding:

The authors disclosed receipt of the following financial support for the research, authorship, and/or publication of this article: National Institutes of Health (grant number NICHD T32 HD 68223–7, T32 DK 063929 and NHLBI K23 HL139992). The first and second authors’ efforts for this work were supported by training grants, and the third author’s efforts were supported by a career development award, each from the National Institutes of Health.

Abbreviations:

QOL: quality of life
RCTs: randomized controlled trials
PICO: population, intervention, control, and outcomes
PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-Analyses
CBT: cognitive-behavioral therapy
PMR: progressive muscle relaxation
mHealth: mobile health

Footnotes

Conflict of Interest: The authors report no relevant conflict of interest

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Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

Supinfo

NIHMS1837109-supplement-Supinfo.docx^{(13.8KB, docx)}

[R1] 1.Vos T, Abajobir AA, Abate KH, et al. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet 2017; 390: 1211–1259. DOI: 10.1016/S0140-6736(17)32154-2. [DOI] [PMC free article] [PubMed] [Google Scholar]

[R2] 2.Ashina M, Katsarava Z, Do TP, et al. Migraine: epidemiology and systems of care. The Lancet 2021; 397: 1485–1495. DOI: 10.1016/S0140-6736(20)32160-7. [DOI] [PubMed] [Google Scholar]

[R3] 3.Stovner LJ, Nichols E, Steiner TJ, et al. Global, regional, and national burden of migraine and tension-type headache, 1990–2016: a systematic analysis for the Global Burden of Disease Study 2016. The Lancet Neurology 2018; 17: 954–976. DOI: 10.1016/S1474-4422(18)30322-3. [DOI] [PMC free article] [PubMed] [Google Scholar]

[R4] 4.Abu-Arafeh I, Razak S, Sivaraman B, et al. Prevalence of headache and migraine in children and adolescents: a systematic review of population‐based studies. Developmental Medicine & Child Neurology 2010; 52: 1088–1097. DOI: 10.1111/j.1469-8749.2010.03793.x. [DOI] [PubMed] [Google Scholar]

[R5] 5.Victor TW, Hu X, Campbell JC, et al. Migraine prevalence by age and sex in the United States: a life-span study. Cephalalgia 2010; 30: 1065–1072. DOI: 10.1177/0333102409355601. [DOI] [PubMed] [Google Scholar]

[R6] 6.Becker WJ, Findlay T, Moga C, et al. Guideline for primary care management of headache in adults. Canadian Family Physician 2015; 61: 670–679. [PMC free article] [PubMed] [Google Scholar]

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PERMALINK

Digital Headache Self-Management Interventions for Patients with a Primary Headache Disorder: A Systematic Review of Randomized Controlled Trials

Amy Noser

Robert Gibler

Rachelle Ramsey

Rebecca Wells

Elizabeth Seng

Kevin Hommel

Abstract

Objective:

Background:

Methods:

Results:

Conclusions:

Method

Data Search.

Article Selection.

Data Extraction.

Quality Assessment.

Analysis.

Results

Figure 1.

Table 1.

Intervention characteristics

Intervention digital medium.

Intervention outcomes.

Frequency.

Duration.

Severity.

Intensity.

Disability.

Quality of Life.

Study Quality.

Revised Cochrane Risk-of-Bias.

Table 2.

Sample Size.

Discussion

Conclusion

Supplementary Material

Funding:

Abbreviations:

Footnotes

References

Associated Data

Supplementary Materials

ACTIONS

PERMALINK

RESOURCES

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