Comparing the effectiveness of online therapy versus in-person therapy in youth: protocol for a non-inferiority randomized controlled trial

Abstract

Background

The prevalence of mental health issues in young people is staggering, yet many face barriers in accessing professional help. These barriers, including stigma and long waiting lists, can prevent those in need from receiving the support they require. Teletherapy, which utilizes technology to connect individuals with mental health professionals, is emerging as a promising solution to overcome these obstacles. The COVID-19 pandemic has accelerated the adoption of online therapy globally, with therapists swiftly transitioning to digital platforms. The effectiveness of online therapy in youth, and factors that may potentially affect this, warrant further investigation. In a randomized controlled trial, this study therefore aims to compare the results of online Acceptance and Commitment Therapy (ACT) and Eye Movement Desensitization and Reprocessing (EMDR) therapy to traditional in-person treatment, thereby investigating the modifying role of therapeutic alliance, willingness to participate in teletherapy sessions, age, and gender.

Methods

The study will use a randomized non-inferiority design and block randomization to assign help-seeking young people aged 12–18 that are eligible for EMDR or ACT treatment to either online or in-person therapy in specialized mental health care (SMHC ). Data analysis will include both intention-to-treat and “per protocol” analyses using mixed models. Participants and their caregiver(s) will complete questionnaires on societal functioning and symptom severity at baseline, at the end of treatment and at 6-month follow-up. Therapeutic alliance will be assessed 2 months into treatment and at the end of treatment. Peer experts were actively involved in the study design to ensure the incorporation of patient and relative perspectives.

Discussion

This study seeks to assess whether teletherapy can be a viable and accessible option for young people in need of mental health support. The findings from this research have the potential to inform mental health services and policies, and to contribute to the ongoing development of digital mental health interventions for young people. Ultimately, the study’s results may help improve access to mental health care and support for young people facing barriers to traditional in-person therapy.

Trial registration

ClinicalTrials.gov NCT06617663. Registered on September 27, 2024.

Supplementary Information

The online version contains supplementary material available at 10.1186/s13063-025-09312-9.

Introduction

Background and rationale {6a}

Mental health issues are highly prevalent among children and teenagers. According to the World Health Organization [1], it is estimated that globally one in seven adolescents aged 10 to 19 (14%) experience disabling mental health problems. Statistics Netherlands reported in 2021 a significant rise in mental health issues among Dutch young people aged 12 to 18 compared to pre-pandemic levels. This upward trend has continued into 2023, even after the pandemic resided [2]. While it is known that mental health problems have a strong negative impact on quality of life and social functioning [3], many young people do not receive the help they need in part because of stigma and long waiting lists [4]. In recent years, a tension has emerged between the increasing demand for specialized mental health services among young people and the shortage of available resources including personnel to meet these needs [5, 6].

To address the challenges in accessing mental health care, technology-based solutions are increasingly being adopted to meet the growing demand for support [7]. Teletherapy, which encompasses the delivery of therapeutic services through digital platforms, videoconferencing, and electronic health (e-health) applications, allows individuals to connect with mental health professionals regardless of their physical location [8–10]. Additionally, teletherapy provides the convenience of receiving treatment from home, helping to reduce the stigma often associated with seeking mental health care by allowing users to access services discreetly and privately [11]. The flexibility in scheduling and the lack of travel time also make it easier for individuals to incorporate therapy sessions into their busy lives. Given that young people are generally skilled in information and communication technology (ICT) and show a strong interest in utilizing technology-based interventions, these solutions hold significant promise for improving access to mental health support for youth [12].

Prior to the onset of the COVID-19 pandemic, teletherapy initiatives were already being implemented [13]. Results of studies on teletherapy provided to adults are promising. A 2019 meta-analysis of 33 studies revealed that the majority of the 21 studies that compared the effect of online psychotherapy to traditional face-to-face therapy yielded comparable results across study conditions [14]. During the pandemic, people notably increased their adoption of online therapy globally. Therapists quickly transitioned their practices to digital platforms [15], with video conferencing becoming the primary method of connecting with their patients. A variety of programs emerged, each boasting unique advantages and advanced features to facilitate the shift to teletherapy. For example, research on Eye Movement Desensitization and Reprocessing (EMDR) therapy showed that its effectiveness remained unchanged when its delivery suddenly changed from in-person therapy to online via video calling to patients under and over 18 years of age [16]. A randomized trial in China demonstrated that Acceptance and Commitment Therapy (ACT) among students significantly outperformed a waiting list control group, with positive effects persisting after follow-up [17]. One recent meta-analysis has focused on teletherapy using Cognitive Behavioral Therapy (CBT) specifically for youth, reviewing six randomized controlled trials (RCTs) involving individuals aged 10 to 25 years [18]. This analysis revealed that online CBT—encompassing both self-help programs and professionally supervised interventions—was as effective as traditional in-person CBT in alleviating symptoms of depression and anxiety among young people. These findings indicate that online therapy can become a permanent fixture in mental health care [19]. Despite these encouraging findings, we still have too limited understanding of the effectiveness of fully online therapeutic treatments for youth in mental health care, especially when delivered via video calls combined with digital tools or e-health programs in non-acute (non-pandemic) settings.

Additionally, there is a significant gap in knowledge regarding the factors that may enhance or impede the effectiveness of these online therapies. Results suggest that the effectiveness of online therapy may depend on factors such as trust and willingness to participate in teletherapy sessions, age, gender or therapeutic alliance [20]. The importance of the therapeutic relationship is widely recognized as a critical component in achieving positive mental health outcomes [21]. However, in spite of the recent surge of teletherapy in youth mental health care, the role of potentially modifying factors, particularly the therapeutic alliance, in online settings remains underexplored. A significant concern among healthcare providers and clients is that the therapeutic alliance may be more challenging to establish in online settings, potentially hampering its effectiveness. Some research suggests that, compared to in-person therapy, the therapeutic alliance may be less directly associated with outcomes in digital interventions. Nevertheless, greater involvement and implementation of digital interventions could help strengthen the therapeutic alliance, ultimately leading to improved outcomes [22].

Objectives {7}

To address these knowledge gaps, this study aims to test the hypothesis that online therapy via video calling is not inferior to in-person therapy delivered in a physical therapy room with respect to symptomatic and societal recovery, within a predefined non-inferiority margin. We will also explore potentially confounding factors, including the quality of the therapeutic alliance, willingness to participate in online sessions, age, gender, and symptom severity. By exploring these variables, the study aims to provide a clearer understanding of how online therapy compares to traditional in-person treatment and identify factors that may influence its success.

The following hypotheses will be tested:

• Online therapy is not inferior to in-person therapy in terms of symptomatic recovery.

• Online therapy is not inferior to in-person therapy in terms of societal recovery.

• The established therapeutic relationship is comparable in online and in-person therapy settings.

An expert by experience and professional in a leadership position (i.e., a patient with lived experience relevant to the study topic) was actively involved in the early stages of the study design and development. This dual perspective—as both someone with lived experience and as a professional—contributed significantly to shaping the study’s focus, practical relevance, and participant-centered approach.

Throughout the course of the trial, this expert continues to be consulted at regular intervals to provide feedback on the implementation process and to ensure that the study remains aligned with the needs, expectations, and lived realities of the target population.

Although no formal Patient and Public Involvement (PPI) panel or advisory board was established, the inclusion of this individual reflects the research team’s commitment to meaningful and ongoing involvement of individuals with lived experience.

Trial design {8}

A randomized non-inferiority design will be carried out using four treatment arms (online EMDR or ACT therapy and control groups in-person EMDR or ACT therapy). We will focus on two common treatment approaches that are currently provided in both treatment settings: EMDR and ACT.

Methods: participants, interventions and outcomes

Study setting {9}

This study will include patients aged 12–18 years old that are referred for specialized mental health care (SMHC) to GGZ North-Holland-North (GGZ NHN), a large SMHC institution in the Netherlands. This study is being conducted across five GGZ NHN locations throughout the northwestern region of the country. Figure 1 depicts the study flow.

Fig. 1.

Study flow chart

Eligibility criteria {10}

Participants must be eligible for SMHC, as determined by initial screening at registration or current primary practitioner. We will include patients between 12 and 18 years who present symptoms related to compulsive behaviors, anxiety, trauma, somatic symptom disorder or mood disorders. Efforts will be made to have approximately equal distributions of individuals aged 12–15 and 15–18 years, as well as a balanced representation of both genders.

Exclusion criteria

• Patients who are crisis-prone or who enter services during a crisis, as determined at intake by the screener and/or primary practitioner.

• Patients receiving involuntary care under the Dutch Compulsory Mental Health Care Act (in Dutch: WVGGZ).

• Patients with significant cognitive limitations or insufficient proficiency in the Dutch language, making it impractical to conduct EMDR or ACT in Dutch, as determined by the screener and/or primary practitioner.

Informed consent {26a}

If a patient is considered potentially eligible for the study, they will be asked by the research coordinator for consent to be approached for research participation. For young people aged 12–16, both the patient and their legal guardian(s) will be contacted. For those aged 16–18, only the patient will be approached, though effort will be made to inform the legal guardian(s), with the adolescent’s consent.

Additional consent provisions for collection and use of participant data and biological specimens {26b}

Study data, including psychological assessments and intervention outcomes, will be securely stored for a period of 10 years after study completion in accordance with institutional policies and privacy regulations. Participants will be informed via the consent form about this storage and potential future use of anonymized data for related research. No data will be used for purposes beyond those explicitly stated in the consent without additional approval.

Interventions

Explanation for the choice of comparators {6b}

We will focus on the effectiveness of online EMDR and online ACT therapy; two interventions that are feasible and comparable in online and in-person settings and reach the widest possible target population within the youth’s SMHC.

Intervention description {11a}

• Acceptance and Commitment Therapy (ACT)

ACT is a third-generation action-oriented approach therapy that offers one universal protocol that can be applied to a wide range of mental health problems in adolescents with the goal of improving their cognitive flexibility [23]. Even though cognitive behavioral therapy (CBT) may seem like the obvious research target due to the in-depth knowledge, experience, and scientific evidence for this form of therapy, we chose to focus on the comparable but novel ACT, specifically for youth known as “ACT your Way” in the Netherlands. Unlike CBT, which has specific protocols for different target groups, ACT has one protocol that addresses various issues, including chronic pain, depression, anxiety, and obsessive-compulsive behaviors [24]. It can also be seen as a more flexible approach for young people and despite its limited research so far, early treatment results for ACT are promising [25]. For patients with symptoms related to compulsive behaviors, anxiety, somatic symptom disorder or mood disorders we will use the “ACT your Way” protocol, which is specifically intended for the target group aged 15–25. However, research shows that young people aged 12–15 can also benefit from ACT [26]. Age-appropriate language adjustments will be applied for the younger participants. In-person therapists will follow the “ACT Your Way” manual at a physical location, while online therapists will use the manual through video calls in conjunction with the e-health module developed for the program.

• Eye Movement Desensitization and Reprocessing (EMDR)

For trauma-specific symptoms, EMDR will be used. EMDR is a therapy designed to relieve the distress associated with traumatic memories and has been proven effective for youth with traumatic problems [27]. EMDR in the physical location with a therapist will be carried out with the EMDR lightbar. Online EMDR will be supported by MOOVD, a digital intervention platform [28].

Criteria for discontinuing or modifying allocated interventions {11b}

If the participant indicates they do not want to continue with the intervention, or if the participant experiences a severe worsening of symptoms the primary clinician may decide to discontinue the intervention/study participation.

Strategies to improve adherence to interventions {11c}

To ensure adherence to the treatment protocols, after each session an ACT or EMDR therapist will complete a checklist indicating to what extent the key topics of the protocol were covered. Additionally, peer review meetings will be held every 6 weeks, during which therapists can discuss protocol adherence and ensure that treatment is applied consistently across sessions and settings.

Relevant concomitant care {11d}

All care will be provided according to the principle of "care as usual", holding that clients receive the care they need and only those who are likely to benefit from the interventions under investigation are invited to participate. During the interventions, participants are allowed to receive concomitant care that does not interfere with the treatment. Medication that was initiated prior to the start of the therapy is permitted to continue during the trial. Additionally, supportive interventions directed at parents or caregivers are allowed alongside the participant’s treatment.

Furthermore, the therapist may decide to modify or stop the intervention if there are indications that the treatment is causing adverse effects or is not effective for the participant. All decisions regarding discontinuation or modification will be documented and will involve the therapist and study coordinator as appropriate.

Provisions for post-trial care {30}

After completion of the trial, participants will be referred back to their original treating clinician for continuation or completion of their care. No specific ancillary care is provided by the trial beyond the intervention period. Since the intervention consists of treatment as usual, no significant risk of harm is anticipated. Any adverse events or harm related to trial participation will be managed according to standard clinical procedures. Compensation provisions for trial-related harm follow applicable institutional and legal regulations.

Outcomes {12}

Primary outcome measures:

Domain: Societal functioning

• Measure: KIDSCREEN-27 questionnaire [29], which includes five subscales covering physical activity and health, feelings and self-image, family and leisure, friends, and school and learning.

• Metric: The change from baseline scores, analyzed between the treatment arms.

• Aggregation: Mean scores for each subscale.

• Time point: The primary time point for comparison is end of-treatment, while the follow-up (after 6 months) assessment will be used as an intermediate measure and will be included in longitudinal analyses.

Domain: Symptom severity

• Measure: Youth Outcome Questionnaire (Youth OQ) [30], which serves as a general measure across all arms, evaluating behaviors such as depression, anxiety, somatic symptoms, social isolation, hyperactivity, aggression, and behavioral problems.

• Metric: The change from baseline scores, analyzed between the treatment arms.

• Aggregation: Mean total score and subscale scores.

• Time point: The primary time point for comparison is end of-treatment, while the follow-up (after 6 months) assessment will be used as an intermediate measure and will be included in longitudinal analyses.

Additional measures:

• oFor the EMDR arm, trauma symptoms will be assessed with the Child and Youth Trauma Screener (KJTS) [31].
• oIn the ACT arms, cognitive flexibility will be measured with the Avoidance and Fusion Questionnaire for Youth (AFQ-Y) [32].

Secondary outcome measure:

• Domain: Therapeutic alliance

• Measure: Work Alliance Questionnaire (WAV-12) [33].

• Metric: The primary metric is the absolute score.

• Aggregation: Mean scores.

• Time points: Halfway treatment and end of treatment, with comparisons made between treatment arms (online versus in a therapist’s room).

Participants time line {13}

In Fig. 2, the timeline and questionnaires are presented.

Fig. 2.

Timeline

Sample size {14}

A non-inferiority sample size calculation was performed using the online tool SampSize (https://app.sampsize.org.uk/), based on previous comparative research utilizing the Youth OQ as the primary outcome measure. Based on prior studies, we estimated the standard deviation (SD) for our calculations at 16.6 [34–36], reflecting the variation observed in similar interventions. A non-inferiority margin of 9 points was chosen, which is clinically justified and aligns with the Reliable Change Index (RCI = 10), indicating that differences ≤ 9 points are below the threshold for clinically meaningful change [37].

With 80% power and a one-sided significance level of 0.05, 43 participants per arm are required, totaling 172 participants across the four groups (online EMDR n = 43, in-person EMDR n = 43, online ACT n = 43, in-person ACT n = 43). The decision to use a one-sided alpha of 0.05, rather than the conventional 0.025 in non-inferiority trials, was deliberate. Based on previous research, there is evidence suggesting that online EMDR or ACT is likely not inferior to their in-person counterparts. Additionally, both interventions are already scientifically supported. Therefore, adopting a less stringent alpha is justifiable, as the goal is not to demonstrate superiority, and we aim to ensure a manageable sample size and feasibility of the study [38].

The multi-arm design compares two therapeutic modalities—EMDR and ACT—delivered online and in person, resulting in two primary non-inferiority comparisons: online EMDR vs. in-person EMDR, and online ACT vs. in-person ACT. Formal multiplicity adjustments, such as Bonferroni correction, were not applied, as each comparison addresses a distinct, clinically relevant hypothesis and applying such corrections would reduce power and increase sample size unnecessarily. This approach is consistent with CONSORT recommendations for non-inferiority studies [39].

Although some participants may drop out during the trial, we chose not to oversample upfront, as this would substantially increase the required sample size. Instead, we will monitor retention and data accrual throughout the study, applying SAFE-tests and saturation-based analyses to maintain validity and Type I error control [40]. Both per-protocol and intention-to-treat analyses will be reported to minimize bias and ensure robust estimates of treatment effect. Sensitivity analyses will be conducted to assess robustness under higher SD assumptions or deviations from the margin (Δ = 9) [41].

Recruitment {15}

Participants must be eligible for specialized mental health care, as determined by initial screening at registration or by the current primary practitioner. Patients between 12 and 18 years who present symptoms related to compulsive behaviors, anxiety, trauma, somatic symptom disorder, or mood disorders will be screened to determine whether EMDR or ACT is appropriate for their treatment. Diagnostic questionnaires will be administered to assess the mental health complaints, providing a clear diagnostic profile for their study participation. The ACT and EMDR interventions will be carried out by experienced psychologists/health care workers who have taken certified courses for that purpose. When patients are randomly assigned to online treatment, they are paired with dedicated therapists from the online team who are trained for online ACT or EMDR. Patients assigned to in-person therapy are assigned to therapists trained for ACT or EMDR who work at a location of GGZ-NHN nearest to their home.

Assignment of interventions: allocation

Sequence generation {16a}

Within each treatment group, participants will be randomized to either online or in-person therapy.

The allocation sequence for the online vs. in-person randomization will be generated using a secured computer-generated random number sequence, stratified by treatment modality (ACT/EMDR) gender (male/female) and age group (12–15 years/16–18 years).

Concealment mechanism {16b}

The allocation sequence is securely stored in a password-protected randomization system managed by an independent researcher (EV). No other members of the research team have access to the allocation list. Treatment assignment and location are only revealed to the research coordinator after participant enrollment is complete. This ensures allocation concealment by preventing foreknowledge of upcoming assignments.

Implementation {16c}

Participant enrollment and assignment of participant IDs are conducted by the research coordinator. The actual treatment allocation and location assignment are performed through the secured randomization system controlled by an independent researcher. This separation of duties maintains the integrity of the randomization process and minimizes the risk of selection bias.

Patients will be informed that they will be randomly assigned to online or in-person therapy. Prior to treatment arm allocation, patients and parents will be asked to indicate their preference for online or in-person therapy using a continuous scale (ranging between strong preference for treatment at a physical location, somewhat preference for treatment at a physical location, neutral, somewhat preference for online, strong preference for online). Space will be provided to explain the reason behind their preferences. This will allow us to assess whether prior preferences influence the outcomes of the intervention.

After providing the study information, patients will be given a 2-day reflection period to decide on their participation. After study completion, they may switch to their preferred treatment setting if desired. For both online therapy and in-person therapy, we aim to ensure that the waiting time to start treatment is no longer than 2 months from registration.

Assignment of interventions: blinding

Blinding {17a}

The outcome assessor, as well as the researcher and statistician involved in data analyses, is blinded to treatment allocation to minimize assessment bias. The study condition will only be revealed after data collection has been fully completed and the data has been pseudonymized for the purpose of data analysis. This approach ensures unbiased outcome assessment while allowing proper statistical evaluation.

Unblinding {17b}

Unblinding of the outcome assessor will only occur in exceptional circumstances, such as serious adverse events or if knowledge of the treatment allocation is essential for participant safety or clinical management. Any unblinding events will be documented and justified.

Data collection and management

Plans for assessment and collection of outcomes {18a}

This will involve gathering participant information at baseline (just before randomization), post-treatment, and at the 6-month follow-up. Therapeutic alliance will be assessed 2 months into treatment and at the end of treatment. Validated questionnaires will be administered through an online survey tool (Survalyzer.eu). Participants will be informed that their data will still be included in the analyses if they withdraw from the study, unless they explicitly request otherwise. Figure 2 provides a schematic representation of the data collection.

Plans to promote participant retention and complete follow-up {18b}

To promote participant retention and complete follow-up, we will work in a client-centered manner, taking into account the age and vulnerabilities of the target population, and ensuring privacy at all times. We will maintain regular contact with participants through reminders by phone, email, or SMS, and offer flexible scheduling and options for online data collection to accommodate their preferences. Participants will be clearly informed about the importance of completing follow-up assessments, even if they discontinue or deviate from the assigned intervention.

Key outcome data will be collected from all participants, including those who discontinue or deviate, through abbreviated questionnaires or telephone interviews where possible. As a token of appreciation, participants will receive a gift voucher upon completion of the study assessments.

Data management {19}

Data preparation will be performed independently by two members prior to conducting the main analysis. Data will be kept for 10 years post-study completion before being destroyed as per the Medical Ethical review committee (METC Amsterdam UMC) guidelines. Data is automatically transferred from a secure data collection tool (Survalyzer) to a password-protected database. Data will be checked for quality (e.g., data range, distribution) by the data manager and principal researcher.

Confidentiality {27}

Personal information about participants will be collected in compliance with privacy regulations and stored separately from research data in encrypted files. Access to identifying information is limited to authorized study personnel only.

Participant confidentiality will be maintained throughout the study and after its completion. Data sharing will occur only in anonymized or coded form to prevent identification of individual participants.

Statistical methods

Statistical methods for primary and secondary outcomes {20a}

Data will be analyzed according to the intention-to-treat principle, with all randomized patients included in the analysis, as well as “per protocol.” In both the intention-to-treat and “per protocol” analyses, mixed general linear (or nonlinear, depending on score distribution) models will be performed, where the main effect of treatment and the interaction between effect and treatment setting, willingness and therapeutic alliance are the main measures of interest. Mixed models have the advantage that they 1) account for multiple measures within the same individual, and 2) account for missing values. While primary analyses will rely on these mixed-effects models, additional sensitivity analyses using multiple imputation will be conducted if the extent or pattern of missing data suggests a departure from the MAR (missing at random) assumption. This approach enhances the robustness of the findings by addressing potential biases due to missingness.

Interim analysis {21b}

An interim analysis is planned after 50% of the intended participants have been included. The primary aim of this analysis is to assess the feasibility and preliminary efficacy of the intervention.

While primary analyses will rely on mixed-effects models, additional sensitivity analyses using multiple imputation will be conducted if the extent or pattern of missing data suggests a departure from the MAR (missing at random) assumption. This approach enhances the robustness of the findings by addressing potential biases due to missingness.

Formal safety monitoring or stopping rules based on adverse events are not applicable to this study, as both conditions involve standard mental health care (care as usual) for youth. The only difference between arms is the mode of delivery (online vs. in-person), with no experimental interventions or elevated risk expected. Therefore, no interim safety analysis or predefined stopping criteria are warranted.

Methods for additional analyses {20b}

Subgroup analyses will be performed to explore potential differential treatment effects by gender and age group (12–15 years vs. 16–18 years). Sensitivity analyses may be conducted to assess the robustness of findings to different assumptions about missing data and protocol adherence. Adjusted analyses controlling for relevant baseline covariates will also be performed.

Methods in analysis to handle protocol non-adherence and missing data {20c}

The primary analysis population will be intention-to-treat, including all randomized participants regardless of protocol adherence. Per-protocol analyses will include only those participants who completed the therapy.

Missing data will be handled using mixed models which can accommodate incomplete data under the assumption of missing at random. If missing data is substantial or systematic, multiple imputation techniques will be applied as sensitivity analyses to assess the impact of missingness on the results.

Plans to give access to the full protocol, participant level-data and statistical code {31c}

The full trial protocol, de-identified participant-level data, and statistical analysis code will be made available upon reasonable request to the corresponding author after publication of the main trial results. Data sharing will comply with applicable privacy laws and institutional policies to protect participant confidentiality. Requests will be reviewed by the study steering committee to ensure appropriate use.

Oversight and monitoring

Composition of the coordinating center and trial steering committee {5d}

The day-to-day management and organizational support of the trial is provided by the project management group, which consists of the Principal Investigator and key members of the research team, including a day-to-day trial coordinator, research assistant, and data manager.

This group meets weekly to review trial conduct, recruitment progress, data collection, and address any practical issues arising during the study.

No independent Trial Steering Committee (TSC) has been established for this single-center study. Should the trial expand to multiple centers in the future, an independent TSC will be considered to provide appropriate oversight.

Composition of the data monitoring committee, its role and reporting structure {21a}

This study has been deemed not to fall under the Medical Research Involving Human Subjects Act by the METC (Medical Ethical Review Committee). This statement ensures that the study is not subject to the same ethical oversight requirements as higher-risk studies. Given the exemption from the Medical Research Involving Human Subjects Act and the low-risk nature of the intervention no independent Data Monitoring Committee has been established. Instead, oversight will be provided through regular monitoring by the Project Management Group throughout the study.

Adverse events reporting and harms {22}

Given that the interventions are established psychological treatments already used in clinical practice, the risk of serious harm is expected to be low. Nonetheless, procedures are in place to ensure participant safety, including referral to appropriate care if a participant experiences a crisis or worsening symptoms. Adverse events and serious adverse events will be systematically monitored throughout the trial. Although there is no formal obligation to report serious adverse events to the Medical Ethical Review Committee for this low-risk study, any unexpected or serious events potentially related to the intervention will be documented and communicated to the ethics committee as a precautionary measure.

Frequency and plan for auditing trial conduct {23}

The trial conduct is monitored regularly by the Project Management Group, which meets weekly to oversee recruitment, adherence to protocol, data quality, and to discuss any issues that arise during the study. In addition, trial progress and conduct are reviewed every 4 to 6 weeks by the PIs. No annual sponsor audit has been established. Instead, oversight will be provided through regular monitoring by the Project Management Group throughout the study.

Plans for communicating important protocol amendments tot relevant parties {25}

Any amendments to the study protocol will first be submitted to and approved by the study sponsor and funder. Following approval, the principal investigator will inform all involved clinicians and research assistants of the changes. A revised version of the protocol will be distributed to site investigators and added to the trial master file and site files. Additionally, any amendments will be updated in the PROSPERO trial registry.

All protocol deviations or breaches will be fully documented using a protocol deviation or breach report form, specifying the nature, reason, and potential impact of the deviation. Major protocol violations will be reported to the sponsor and, if applicable, to the ethics committee in accordance with institutional and regulatory requirements.

Dissemination {31a}

Authorship of future publications arising from this trial will be determined in accordance with the International Committee of Medical Journal Editors (ICMJE) guidelines. Individuals who have made substantial contributions to the conception or design of the work, data acquisition, analysis, or interpretation, drafting or revising the manuscript critically for important intellectual content, and have approved the final version will be eligible for authorship. All authors will be accountable for the accuracy and integrity of the reported work. The order of authorship will be decided collectively by the study team based on the level of contribution. Contributors who do not meet the criteria for authorship will be acknowledged appropriately.

Discussion

The study protocol outlined above aims to investigate the effectiveness of online therapy compared to traditional in-person therapy for young people experiencing mental health issues. The use of technology-based interventions, such as teletherapy, has the potential to overcome barriers to accessing mental health support, including stigma, accessibility, and waiting lists. The convenience and flexibility of online therapy make it an attractive option for young people who are already accustomed to using technology in their daily lives.

The choice of ACT and EMDR for this study is based on their feasibility and comparability in both online and in-person settings. These interventions have been shown to be effective or promising in treating a range of mental health issues, including anxiety, trauma, compulsive behaviors, somatic symptom disorder, and mood disorders. By comparing the outcomes of online therapy with in-person therapy, this study will provide valuable insights into the potential benefits of teletherapy for young people in the mental health care system.

Overall, the study protocol presented in this paper addresses a significant gap in the literature by investigating the value of online therapy for young people with mental health issues. By incorporating peer experts in the design and execution of the study, the research team aims to ensure that the results are implemented effectively in treatment practice. This study has the potential to improve access to mental health support for young people and contribute to the growing body of evidence on the use of technology-based interventions in mental health care.

Trial status

Protocol version number: 2

Date: October 2025.

Approval starting date: The trial received approval to commence from the Clinical Trial Board, starting on the 26 of September 2024 as documented in the registry on ClinicalTrials.gov.

Approximate date when recruitment will be completed: March 2027.

Abbreviations

ACT

Acceptance and Commitment Therapy

AFQ-Y

Avoidance and Fusion Questionnaire – Youth version

EMDR

Eye Movement Desensitization and Reprocessing

GGZ NHN

Mental Health Care North Holland North (in Dutch: Geestelijke Gezondheidszorg Noord-Holland-Noord)

ICMJE

International Committee of Medical Journal Editors

ICT

Information and Communication Technology

KJTS

Children and Youth Trauma Screening Questionnaire (in Dutch: Kinder- en Jeugd Trauma Screening)

MAR

Missing at random

METC

Medical Ethics Review Committee (in Dutch: Medisch Ethische Toetsingscommissie)

PhD student

Doctoral Researcher

PMG

Project Management Group

PI

Principal Investigator

RCI

Reliable Change Index

RCT

Randomized controlled trial

SD

Standarddeviation

 SMHC

Specialized Mental Health Care )

TSC

Trial Steering Committee

UMC

University Medical Center

VCVCZ

Christian Association for Mental and Neurological Health Care (in Dutch: Vereniging voor Christelijke Verzorging van Geestes- en Zenuwzieken)

WAV-12

Work Alliance Questionnaire (12-item version) (in Dutch: Werkalliantievragenlijst – 12 items)

Youth OQ

Youth Outcome Questionnaire

Authors’ contributions {31b}

EtB, SV, and EV drafted this paper which was added to and modified by all other authors. EtB, FS, and EV designed the study. EtB coordinates the study. EtB and IV facilitate training for therapists involved in the study. SV and EtB monitor study enrollment. All authors read and approved the final manuscript.

Funding {4}

This study was supported financially by Stichting tot Steun VCVGZ, the Netherlands.

Data availability {29}

The final trial dataset will be accessible to the principal investigators and authorized members of the research team involved in the study. Access will be controlled to ensure compliance with data protection regulations and participant confidentiality. There are no contractual agreements limiting investigator access to the data. Upon reasonable request and following approval by the study steering committee, anonymized data may be shared with external researchers for further scientific analyses, in accordance with applicable privacy laws and ethical guidelines.

Declarations

Ethics approval and consent to participate {24}

This study has been approved by the ethics committee of the Amsterdam University Medical Center (Ethics approval number 2023.1018). Participants (and their caregivers for this < 16) will provide written informed consent and will be informed of their right to withdraw from the study before participation.

Consent for publication {32}

An example informed consent can be requested by sending an email to the corresponding author.

Competing interests {28}

The authors declare that they have no competing interests.