Effectiveness of Eye Movement Desensitisation and Reprocessing (EMDR) Therapy in reducing infertility distress in women: a community-based randomised crossover trial protocol

Abstract

Introduction

Infertility is a global health concern affecting 10%–15% of couples, often accompanied by profound psychological distress for women. Various psychological interventions being trialled in this population, outcomes have been mixed, underscoring the need for innovative therapeutic approaches. Eye Movement Desensitisation and Reprocessing (EMDR) therapy, originally developed for trauma-related conditions, is a promising alternative. This study aims to evaluate the effectiveness of EMDR therapy in reducing infertility-related distress and improving psychological well-being among women undergoing fertility treatment.

Methods and analysis

This is a randomised crossover trial with two groups: an immediate EMDR therapy treatment group and a waitlist control group. 64 women who meet eligibility criteria for infertility-related psychological distress will be randomly assigned (1:1) using block randomisation. The intervention consists of 6 weekly EMDR sessions delivered by an accredited EMDR practitioner. Outcomes will be measured at baseline, post-treatment and 3-month follow-up. Outcomes include infertility-related distress measured by the Infertility Distress Scale (IDS) and Fertility Quality of Life scale (FertiQoL), Depression Anxiety and Stress Scale (DASS-21), trauma symptoms measured by the PTSD Checklist for DSM-5 (PCL-5) and the Impact of Event Scale – Revised (IES-R), psychological well-being measured by Ryff’s Psychological Well-Being Scale (PWBS), self-esteem measured by the Rosenberg Self-Esteem Scale (RSES), general health measured by the 36-Item Short Form Health Survey (SF-36) and coping strategies measured by the Brief Coping Orientation to Problems Experienced Inventory (Brief-COPE). A qualitative component using reflexive thematic analysis will explore participants’ subjective experiences of EMDR and infertility.

Ethics and dissemination

This trial has received ethical approval from the RMIT University Human Research Ethics Committee (2025-28286-27180). Results will be disseminated through peer-reviewed publications, conference presentations and participant summaries. All participants will provide written informed consent, and those in the waitlist group will receive the intervention following the initial study period, aligning with ethical principles of beneficence and justice.

Trial registration number

ACTRN12624001289505p.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• This study employs a randomised crossover design, allowing each participant to serve as their own control.

• The use of blinded outcome assessors minimises bias in data collection.

• Multiple validated psychometric instruments are used to capture changes in distress and well-being.

• A qualitative component complements quantitative findings to enhance methodological triangulation.

• Neither participants nor therapists can be blinded to treatment allocation, which may introduce expectancy bias.

Introduction

Infertility affects approximately 10%–15% of couples globally, with many individuals (particularly women) experiencing significant psychological distress as a result.^{1 2} This distress may be associated with the fertility experience directly, but also from the milieu of social, occupational, relational and health challenges that often accompany fertility treatment.³ This distress can manifest as anxiety, depression and reduced well-being.⁴ Women undergoing fertility treatments frequently face profound emotional challenges, including miscarriage, failed in vitro fertilisation (IVF) cycles and disruptions to their expected life course.⁵ These experiences can lead to lasting psychological distress, which traditional therapeutic approaches may not fully address.^{4 6 7}

Despite the prevalence of infertility affecting both sexes equally, the psychosocial impact of infertility is often more pronounced in women.⁸ In many societies, motherhood remains central to identity and women report higher instances of social stigma, guilt and relationship strain compared with men.^{9 10} Men also experience psychological distress related to infertility; however, women consistently report higher levels of distress due to the combined effects of gendered social expectations, greater treatment invasiveness and identity-related factors.^{2 10 11} Accordingly, this study focuses on women to better understand and address the unique psychological sequelae of infertility in this population.

A range of psychological interventions have been trialled in this population with limited positive outcomes, highlighting the need for innovative treatments.¹² One such potential treatment is Eye Movement Desensitisation and Reprocessing (EMDR) therapy. EMDR therapy was first developed by Francine Shapiro in 1987 for trauma-related disorders.¹³ Recent studies suggest that EMDR therapy is effective in treating various forms of psychological distress and has assisted individuals in fostering new perspectives and coping mechanisms.¹⁴ This makes EMDR a promising approach for addressing the emotional pain linked to fertility challenges.

The aim of this study is to evaluate the effectiveness of EMDR therapy in reducing infertility-related distress in women. The study aims to help women navigate the emotional complexities of fertility challenges by using EMDR as a therapeutic intervention. The anticipated benefits include the identification of a novel therapeutic approach to alleviate the psychological distress linked to infertility, potentially improving both mental health and overall quality of life for women. The study will evaluate changes in psychological outcomes, including depression, anxiety and stress, as well as improvements in self-esteem, coping strategies and quality of life. In addition to these quantitative outcomes, a qualitative component will explore the following research question: How do women perceive their emotional and psychological experiences of infertility before, during and after receiving EMDR therapy?

The primary hypothesis focuses on the direct impact of EMDR therapy on infertility-related distress. Secondary hypotheses examine the effect of EMDR therapy on additional key psychological outcomes, anxiety, depression, trauma symptoms and psychological well-being. Exploratory analyses will examine potential moderating factors, specifically adverse childhood experiences (ACE) and attachment-related anxiety or avoidance. The study aims to test the following hypotheses:

Hypothesis 1

There will be a significant difference in infertility-related distress between women who receive EMDR therapy and those in the waitlist control group at treatment completion and at 3-month follow-up.

Hypothesis 2

There will be differences in anxiety, depression and trauma-related symptoms between women who received EMDR therapy and those in the waitlist control group at treatment completion and at 3-month follow-up.

Hypothesis 3

There will be differences in psychological well-being, overall well-being and coping strategies at treatment completion between women who receive EMDR therapy and those who are in the waitlist control group at treatment completion and at 3-month follow-up

Hypothesis 4

Women who report higher ACEs will show significantly different changes in all outcome measures (infertility-related distress, anxiety, depression, trauma symptoms, psychological well-being, self-esteem and coping strategies) at post-intervention and 3-month follow-up.

Hypothesis 5

Women who report higher levels of attachment-related anxiety and avoidance will demonstrate significantly different patterns of change in all outcome measures (infertility-related distress, anxiety, depression, trauma symptoms, psychological well-being, self-esteem and coping strategies) at post-intervention and 3-month follow-up.

Method

Study design

This randomised crossover trial proposes to determine the effects of EMDR therapy on infertility-related distress in infertile women. The study employs a crossover control design with two conditions (EMDR therapy and crossover waitlist control) where participants will be measured at three time points (pre-treatment, post-treatment and follow-up). For a full list of measurements, see online supplemental material. Participants will be randomly assigned to one of two groups: the immediate treatment group or the waitlist control group. The methodology ensures thorough evaluation of the intervention while meeting ethical standards by eventually providing the intervention to all participants (see figure 1).

Figure 1. Proposed study design using a randomised crossover trial. EMDR, Eye Movement Desensitisation and Reprocessing therapy.

The primary outcome is infertility-related distress, while secondary outcomes include anxiety, depression, trauma-related symptoms, psychological well-being, self-esteem and coping strategies. The moderator variables are adverse childhood experiences (ACEs¹⁵) and attachment-related anxiety and avoidance¹⁶, examined to explore individual differences in treatment response.

In addition to quantitative outcomes, a qualitative component is embedded throughout the intervention to capture participants’ lived experiences of infertility and their evolving responses to EMDR therapy. Qualitative data are collected at three stages consistent with the EMDR eight-phase protocol:

1. Phase 1: History taking and treatment planning during the first EMDR session, qualitative data are gathered through open-ended exploration of participants’ fertility history, life context and emotional responses to infertility. This phase documents how women construct meaning around their experiences and identify core memories and beliefs related to infertility distress.

2. Phases 4–8: Reprocessing and re-evaluation Throughout the six-session EMDR intervention, process-level qualitative data are collected at every session using a structured phase 8 re-evaluation form. This form includes fixed questions about changes in thoughts, emotions, body sensations and perceived effectiveness of therapy (eg, ‘Since our last session, have there been any changes in your thoughts, feelings or behaviours related to the target memory?’; ‘What stood out to you most about today’s session?’). Participants will also provide 1–10 ratings of session comfort, effectiveness and confidence in progress, yielding both qualitative and quantitative process data.

3. Final session: Integration and reflection At the completion of the EMDR intervention, participants will take part in a structured qualitative interview exploring their overall therapeutic journey, perceived challenges, meaning-making and future orientation (eg, ‘what has it been like for you to engage in EMDR therapy?’; ‘have you noticed any shifts in how you see yourself or the world since beginning EMDR?’; ‘what does healing mean to you now, after doing this work?’).

   This multistage qualitative design provides insight into both the process and outcomes of EMDR therapy, allowing exploration of mechanisms of change and integration of quantitative and qualitative findings.

An a priori power analysis was conducted using G*Power V.3.1.9.7¹⁷ to determine the required sample size for detecting a medium effect size in a mixed-design analysis of variance (ANOVA) with two groups (EMDR vs waitlist control) and four repeated measures (pre–post, follow-up, 3-month follow-up assessments), at a 5% alpha level and 95% power. The calculation was based on the primary outcome measure, infertility-related distress (Infertility Distress Scale (IDS)).¹⁸ The analysis indicated a required total sample size of N=64 (32 participants per group), providing sufficient power to test the study’s primary hypotheses.

Inclusion criteria

To be eligible for participation, women must be over 18 years of age and have no history of live births or biological children, whether through natural conception or assisted reproductive technologies (ART). To be eligible, women must self-identify as proficient in English, indicating that they can understand both verbal and written materials in the language. All participants must agree to random assignment to either the immediate treatment or waitlist control group and comply with the study timeline, including attending therapy sessions (in person) and completing follow-up assessments.

Exclusion criteria

Women will be excluded from the study if they have previously received EMDR therapy for infertility-related distress, as this ensures accurate assessment of the intervention’s efficacy. Additionally, women who are currently pregnant, have given birth to a biological child or are raising children through adoption or surrogacy will not be eligible. Participants must experience significant emotional distress related to infertility, measured either by the IDS¹⁸ or the Depression Anxiety and Stress Scale (DASS-21)¹⁹ (see online supplemental material). Participants who screen positive via clinical interview for severe psychiatric disorders (eg, schizophrenia, bipolar disorder), current suicidal ideation or a history of suicide attempts within the past 12 months will be excluded for safety reasons. Women with active substance use disorders, unmanaged medical conditions or cognitive impairments that hinder participation will also be excluded. Non-proficiency in English and an unwillingness or inability to comply with study protocols, including random assignment and commencement of therapy sessions, will result in exclusion.

If someone enquires about the reasons for these exclusion criteria, it will be explained in non-judgemental terms, emphasising that the exclusion is based on the need to ensure that participants are in an appropriate state to engage with the therapeutic process. Similarly, exclusion based on severe health or welfare conditions will be communicated to participants by explaining that these factors may reduce their likelihood of benefitting from the intervention if included in the study. Participants will also be made aware that these exclusions are in place to protect their well-being and ensure the safety of the research process.

Procedure

This study is a randomised controlled crossover trial investigating the effectiveness of EMDR therapy in reducing infertility-related distress. The trial has received ethics approval from the RMIT University Human Research Ethics Committee. The total study duration is projected to be approximately 18 months, including recruitment, intervention delivery and follow-up assessments. Each participant’s involvement will span approximately 24 weeks (6 weeks of EMDR intervention or waitlist, followed by two sequential 6-week follow-up phases). This time frame is considered realistic given anticipated recruitment rates, participant availability and clinic scheduling capacity.

Recruitment will occur through social media platforms, posters and collaborations with professional networks. Recruitment materials will include a QR code and web link directing potential participants to the Participant Information and Consent Form. During the informed consent process, participants will be advised that the intervention comprises a defined number of EMDR sessions tailored to the research protocol and may not address all therapeutic needs.

Following consent, potential participants will complete an online eligibility screening questionnaire. Those who meet the initial eligibility criteria will be invited to a 60 min clinical interview and mental state examination with a senior clinical psychologist. During this interview, participants will be screened for severe psychiatric disorders, current suicidality and active substance use disorders, and further information about the study will be provided. The administration of the Multidimensional Inventory of Dissociation (MID-60)²⁰ will be embedded in this clinical interview to evaluate dissociative symptoms and ensure eligibility for study inclusion. Eligibility will be confirmed, and pretreatment measures will be administered (see online supplemental material).

Participants will be randomly assigned to either the immediate EMDR treatment group or the waitlist control group using block randomisation with a 1:1 allocation ratio to ensure balanced group sizes. Due to the nature of the intervention, it is not possible to blind participants or therapists. However, allocation concealment will be maintained through the use of an independent clinical psychologist and a PhD-qualified statistician, neither of whom will be involved in delivering the intervention.

The immediate treatment group will receive 6 weekly EMDR sessions, each lasting 60–90 min, conducted by a psychologist registered with the Australian Health Practitioner Regulation Agency and credentialed by the EMDR Association of Australia. Sessions will be conducted individually and follow standard EMDR protocol with adaptations relevant to infertility distress (see online supplemental material 2). Sessions will be video-recorded and assessed for treatment fidelity by an EMDR-trained supervisor. At the end of each session, participants will be invited to respond to qualitative prompts, such as ‘what stood out to you most today?’ or ‘do you have any additional thoughts, concerns or insights?’ These questions aim to capture emotional and cognitive shifts during reprocessing. These reflections will inform part of the qualitative component of the study.

Participants in the waitlist control group will begin the same EMDR intervention following a 6–8-week delay. This design ensures that all participants receive the active treatment, supporting ethical standards of beneficence and justice. Outcome assessments will be conducted at four time points: baseline (T1: baseline), post-treatment (T2: post-intervention or post-waitlist period), 12-week follow-up (T3: 6 weeks after T2) and 18-week follow-up (T4: 6 weeks after T3).

Participants requiring additional support following participation will be referred to appropriate healthcare providers or mental health services. This ensures continuity of care while maintaining the integrity of research boundaries.

Quantitative and qualitative data will be collected in line with the study aims. Outcome assessors will remain blinded to group allocation to minimise detection bias. A flow diagram outlining the full study procedure is presented in figure 2.

Figure 2. Procedure flow chart. DASS-21, Depression Anxiety and Stress Scale; EMDR, Eye Movement Desensitisation and Reprocessing therapy; IDS, Infertility Distress Scale; MID-60, Multidimensional Inventory of Dissociation-60.

Participant Retention and data management

To promote participant retention and ensure complete follow-up, participants will receive regular email reminders about upcoming sessions and assessment time points, as well as a summary of their contribution at study completion. Participants who discontinue or deviate from the intervention protocol will be encouraged to complete follow-up assessments where appropriate. All outcome data, including psychological distress, well-being and treatment feedback measures, will be collected where possible, even if participants do not complete all sessions.

Data will be entered into a secure, password-protected database hosted on RMIT University’s research server. A double data entry protocol will be employed for quantitative data to minimise errors. Range checks and validation rules will be implemented to ensure accuracy and consistency. Qualitative data will be de-identified and coded using NVivo software. All data will be stored in accordance with RMIT’s Research Data Management Policy, with access restricted to authorised personnel only.

Patient and public involvement

None.

EMDR procedure

The EMDR technique used in this study is based on Francine Shapiro’s original protocols, developed in 1987 to treat trauma and related psychological distress.²¹ EMDR therapy involves a structured eight-phase protocol, where clients are guided to recall distressing memories while simultaneously engaging in bilateral stimulation, typically through guided eye movements. This process facilitates the processing and integration of negative emotions associated with traumatic events, promoting emotional regulation and psychological healing.¹³

Research indicates that EMDR therapy has low risks for patients and high efficacy in processing negative emotions and decreasing distress related to adverse events (AEs) and memories.¹⁴ Recently, the application of EMDR as a psychotherapy is no longer restricted to traumatic disorders. Several studies have been conducted to verify its efficacy in other mental health conditions such as anxiety, depression, phobia, obsessive-compulsive disorder (OCD) and panic disorder.^{22 23} Specifically, meta-analyses have found that EMDR is effective in reducing symptoms of PTSD and other trauma-related conditions.22,24

The EMDR procedure in this study is an adaptation of the protocol described by Bal and Uçar²⁵, with the following adjustments: psychoeducation on EMDR and a stabilisation exercise (the ‘safe/calm place’ technique from Shapiro¹³) are introduced in the first session. Additionally, if participants experience distress during sessions three, four or five (see online supplemental material 2), stabilisation techniques will be used before the session ends to ensure they leave feeling comfortable. Ensuring client stability at the end of an EMDR session is a standard protocol²⁶ and detailed instructions for these techniques can be found in Shapiro¹³ pp. 245–255. These techniques typically take 10 minutes to implement.

Target memory selection and ranking will be guided by a structured EMDR case formulation process. During the initial history-taking session, participants will identify distressing infertility-related memories or situations. Each will be rated using the Subjective Units of Disturbance Scale (SUDS²⁷) to establish an intensity hierarchy. The initial ‘touchstone’ memory (typically the earliest memory linked to the presenting distress) will be processed first to access the broader maladaptive memory network. Subsequent targets will be selected based on a combination of emotional intensity (SUDS rating) and thematic relevance. This approach aligns with the standard EMDR target sequencing strategy.¹³

Data analysis

Descriptive statistics

All data recorded in Qualtrics will be exported into IBM SPSS Statistics (V.29) for all data analyses. To summarise the demographic and baseline characteristics of the participants, demographic data will be collected after inclusion in the study. Means and SDs will be calculated for continuous variables such as age, duration of infertility and number of previous infertility treatments. Frequencies and percentages for categorical variables (education level, cause of infertility, education level, marital status, household income) will be calculated. To ensure that the experimental group and cross-over control groups are equivalent at baseline, an independent samples t-test will compare DASS-21, IDS, FertiQoL²⁸, Ryff’s Psychological Well-Being Scale (Ryff’s PWBS²⁹), SF-36³⁰, RSES³¹, Brief-COPE³², IES-R³³, PCL-5³⁴ scores between the immediate-treatment and wait-list control groups. When multiple comparisons are performed, a Bonferroni-adjusted pvalue will be applied to control for family-wise error rate.^{35 36}

Hypothesis 1

To assess differences in infertility-related distress between women who receive EMDR therapy and those in the waitlist control group at treatment completion and 3-month follow-up, a 2 (condition: EMDR vs waitlist) × 3 (time: pretreatment, post-treatment, follow-up) Mixed-Design ANOVA will be conducted. Dependent variables will include scores from the IDS and Fertility Quality of Life Scale (FertiQoL). Significant interaction effects between time and condition will be explored using Bonferroni-adjusted post hoc comparisons to identify specific within- and between-group differences while controlling for family-wise error.³⁶

Hypothesis 2

Differences in anxiety, depression and trauma-related symptoms between the EMDR and waitlist control groups will be examined using Mixed-Design ANOVAs for each construct. The dependent variables will include the DASS-21, PCL-5 and IES-R. The model will test for time×condition interactions across pretreatment, post-treatment and 3-month follow-up assessments. Significant interactions will be followed up with Bonferroni-adjusted post hoc tests to locate specific time points of change.³⁶

Hypothesis 3

To examine changes in psychological well-being, overall health and coping strategies across time and condition, a Mixed-Design ANOVA will be performed on scores from Ryff’s PWBS, the SF-36 and the Brief COPE. Time×condition interactions will identify whether improvements differ between EMDR and control participants at post-treatment and follow-up. Bonferroni corrections will again be applied to control for multiple comparisons.

Hypothesis 4

The influence of ACE-Questionnaire (ACE-Q) on treatment outcomes will be explored using hierarchical multiple regression analyses. Change scores (from pretreatment to post-treatment and to follow-up) will be calculated for each outcome variable (infertility-related distress, anxiety, depression, trauma symptoms, psychological well-being, self-esteem and coping). ACE-Q scores will be entered as predictor variables to determine whether higher ACEs predict different magnitudes of change across these measures.

Hypothesis 5

To assess the role of attachment-related anxiety and avoidance (Adult Attachment Scale; AAS) on treatment outcomes, hierarchical multiple regression analyses will be conducted using the same approach as above. AAS subscales (Close, Depend and Anxiety) will be entered as predictors of change scores on all outcome measures to evaluate whether attachment style moderates’ treatment response over time.

Qualitative data analysis

In addition to quantitative outcomes, qualitative data will be collected to address the research question: How do women perceive their emotional and psychological experiences of infertility before, during and after receiving EMDR therapy? Qualitative data will be gathered throughout the intervention, during the initial EMDR history-taking session, throughout the EMDR reprocessing phase and at treatment completion through a semistructured qualitative interview focusing on participants’ reflections, perceived changes and insights gained through EMDR.

All qualitative data will be audio-recorded and transcribed, and deidentified prior to analysis. Data will be analysed using a reflexive thematic analysis³⁷ which involves a systematic process of familiarisation, coding, theme development and refinement. This method will allow for an in-depth, interpretive understanding of recurring emotional and psychological patterns and themes related to participants' experiences of infertility and their engagement with EMDR therapy.

Data monitoring and adverse events

A formal Data Monitoring Committee has not been established for this trial. Given the low-risk nature of the intervention (EMDR therapy delivered by registered psychologists) and the modest sample size, ongoing data monitoring will be conducted internally by the research team. AEs and participant concerns will be reviewed by the Chief Investigator in consultation with the supervisory team and the RMIT University Human Research Ethics Committee, in line with institutional guidelines. No formal interim analyses are planned due to the limited trial duration and sample size. However, participant safety will be continuously monitored, and the trial may be paused or terminated early if serious AEs or ethical concerns arise. Any such decision will be made collectively by the Chief Investigator and supervising researchers, with final oversight by the Ethics Committee.

AEs will be monitored throughout the trial via check-ins before and after each EMDR session. Any reported or observed distress will be documented and reviewed by the Chief Investigator. Serious AEs (SAEs), such as significant psychological deterioration or suicidality, will be reported to the RMIT Human Research Ethics Committee in accordance with institutional guidelines. Participants will be referred to appropriate services if further support is needed.

No formal external audits are planned due to the low-risk nature of the trial. However, the chief investigator and supervisory team will conduct periodic internal reviews to ensure protocol adherence and ethical compliance.

Ethics and dissemination

This trial has received ethical approval from the RMIT University Human Research Ethics Committee (2025-28286-27180). Results will be disseminated through peer-reviewed publications, conference presentations and participant summaries. All participants will provide written informed consent, and those in the waitlist group will receive the intervention following the initial study period, aligning with ethical principles of beneficence and justice.

Data sharing statement

Deidentified quantitative data generated during this study will be available from the corresponding author on reasonable request, subject to approval by the RMIT University Human Research Ethics Committee and in accordance with institutional data governance policies. Qualitative interview transcripts will not be publicly available due to the sensitive and potentially identifiable nature of the data. Any data sharing will comply with participant consent and ethical guidelines.

Discussion

This study protocol describes a randomised crossover trial designed to evaluate the effectiveness of EMDR therapy in reducing infertility-related distress. Despite growing awareness of the emotional burden associated with infertility, few psychological interventions have been systematically evaluated .^{4 5 7} By adapting EMDR to target distressing infertility-related experiences, this trial seeks to address a critical gap in both fertility research and trauma-focused therapy research.

The study’s crossover design ensures ethical fairness by providing all participants with the active intervention, while the inclusion of both quantitative and qualitative measures will provide a comprehensive framework for the feasibility and acceptability of EMDR in this context. Key methodological strengths include the randomised crossover design, use of validated outcome measures, blinded assessors for data collection, and a structured EMDR intervention tailored to the unique emotional experiences of infertility.

The trial limitations should be acknowledged. Participants and therapists cannot be blinded to treatment allocation, which may increase expectancy effects. Additionally, as the study is exploratory in scope and limited in sample size, findings may not be generalisable to all populations experiencing infertility. Overall, this protocol provides a rigorous foundation for evaluating EMDR therapy and may inform the design of future large scale randomised controlled trials.