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Trial registered on ANZCTR


Registration number
ACTRN12624001289505p
Ethics application status
Not yet submitted
Date submitted
5/10/2024
Date registered
23/10/2024
Date last updated
23/10/2024
Date data sharing statement initially provided
23/10/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Helping Women Overcome Infertility Distress: The Impact of Eye Movement Desensitization and Reprocessing (EMDR) Therapy
Scientific title
Effectiveness of Eye Movement Desensitization and Reprocessing (EMDR) in Reducing Psychological Distress Associated with Infertility in Women: A Randomized Crossover Trial
Secondary ID [1] 313125 0
None
Universal Trial Number (UTN)
U1111-1314-1575
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infertility Distress 335384 0
Condition category
Condition code
Reproductive Health and Childbirth 331960 331960 0 0
Fertility including in vitro fertilisation
Mental Health 332042 332042 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Eye Movement Desensitization and Reprocessing (EMDR) Therapy
Description of the Intervention:
EMDR is a structured therapy that incorporates elements of cognitive-behavioural therapy with bilateral stimulation, typically in the form of guided eye movements.
Procedures and Activities:
Therapeutic Procedures: EMDR therapy will consist of the standard eight-phase approach, including:
History Taking: Understanding participants’ backgrounds, infertility experiences, and distress levels.
Preparation: Educating participants about EMDR and establishing a safe environment.
Assessment: Identifying target memories related to infertility distress and determining negative beliefs.
Desensitization: Using bilateral stimulation to process traumatic memories associated with infertility.
Installation: Reinforcing positive beliefs and cognitive restructuring.
Body Scan: Identifying and processing any physical tension related to the memories.
Closure: Ensuring participants feel grounded and safe at the end of each session.
Re-evaluation: Assessing progress and the effectiveness of the therapy in subsequent sessions.
Intervention Delivery:
Providers: The intervention will be delivered by a qualified psychologist trained in EMDR.
Mode of Delivery: The therapy will be provided face-to-face in a private and comfortable clinical setting to foster a safe therapeutic environment. The intervention will be provided in a one-on-one setting.
Number of Sessions and Duration:
Session Schedule: Participants will attend a total of 6 sessions, each lasting 60-90 minutes.
Frequency: Sessions will occur once a week over a period of 6 weeks.
Intervention code [1] 329701 0
Behaviour
Comparator / control treatment
Comparator: Waitlist Crossover-Control Group
Description: Participants in the waitlist control group will not receive immediate EMDR therapy during the study period but will instead be placed on a waitlist for the intervention.
Procedures and Activities:
Waitlist Period: Participants in this group will be informed that they will not receive the EMDR intervention for a predetermined period (6-8weeks).
Follow-Up Assessments: Participants will complete self-report questionnaires and distress assessments at baseline, 6 weeks, and 12 weeks.
Transition to EMDR Therapy:
Crossover Phase: After the waitlist period, participants will be offered the EMDR therapy as described in the intervention section. This allows them to benefit from the therapeutic approach after the initial wait.
This crossover design helps compare the outcomes of those receiving immediate EMDR therapy with those who wait, providing insights into the effectiveness of the intervention over time.
Control group
Active

Outcomes
Primary outcome [1] 339567 0
Infertility Distress
Timepoint [1] 339567 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up
Primary outcome [2] 339568 0
Fertility Quality of Life
Timepoint [2] 339568 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up
Primary outcome [3] 339570 0
Psychological Distress
Timepoint [3] 339570 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up
Secondary outcome [1] 440459 0
Psychological Well-Being
Timepoint [1] 440459 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up
Secondary outcome [2] 440460 0
Self-Esteem
Timepoint [2] 440460 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up
Secondary outcome [3] 440461 0
Coping
Timepoint [3] 440461 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up
Secondary outcome [4] 440462 0
PTSD Symptoms
Timepoint [4] 440462 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up
Secondary outcome [5] 440463 0
Depression
Timepoint [5] 440463 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up
Secondary outcome [6] 440464 0
Anxiety
Timepoint [6] 440464 0
Screening, Baseline, Post-completion of 6-week treatment/waitlist period, 3-month Follow-up

Eligibility
Key inclusion criteria
To be eligible for participation, women must be 18 years and over in 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. Women engaged in in vitro fertilisation (IVF) are eligible, but those involved with other forms of ART will not be included. 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 and completing follow-up assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key 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 by the Infertility Distress Scale and the Kessler Psychological Distress Scale. Those scoring less than 20 on either scale will be excluded. Women currently undergoing psychological treatment (outside of service mandated 1-2 sessions of ART counselling) for infertility-related distress or other reproductive health issues, or who are within the first three months of fertility treatments with a service are not eligible. Participants who screen positive via clinical interview for severe psychiatric disorders (e.g., 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
An a priori power analysis was conducted using G*Power version 3.1.9.7 (Faul et al., 2007) assuming a 5% error rate, two-sided significance level, 95% confidence interval, for detecting a medium effect, was N = 64 for a mixed design ANOVA. Thus, this study proposes a sample size of N = 64 (32 participants in each group) will be adequate to test the study hypotheses.
Descriptive Statistics: Data will be analysed in IBM SPSS (Version 29). Means and standard deviations will be reported for continuous variables (e.g., age, infertility duration), and frequencies for categorical variables (e.g., cause of infertility). An independent samples t-test will ensure baseline equivalence between the EMDR and control groups.
A series of Mixed-Design ANOVAs will assess differences between the EMDR and waitlist control groups at three time points (pre-treatment, post-treatment, and follow-up) for the following outcomes:

Infertility distress (FertiQoL, IDS)
Anxiety (BAI)
Depression (BDI)
Trauma-related symptoms (IES-R)
Psychological well-being (Ryff's PWBS)
Coping strategies (Brief-COPE)
Each Mixed-Design ANOVA will examine interaction effects between time (pre-treatment, post-treatment, follow-up) and condition (EMDR vs. waitlist control). If significant interactions are found, post-hoc tests will be conducted. Assumptions of normality, homogeneity of variances, and sphericity will be tested.
Thematic analysis will be used to explore participants’ emotional and psychological experiences of infertility before, during, and after EMDR therapy, with data collected during EMDR sessions and through open-ended questions.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
24/03/2025
Actual
Date of last data collection
Anticipated
21/07/2025
Actual
Sample size
Target
64
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 317567 0
University
Name [1] 317567 0
RMIT University
Country [1] 317567 0
Australia
Primary sponsor type
University
Name
RMIT University
Address
Country
Australia
Secondary sponsor category [1] 319877 0
None
Name [1] 319877 0
Address [1] 319877 0
Country [1] 319877 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 316276 0
Royal Melbourne Institute of Technology Human Research Ethics Committee
Ethics committee address [1] 316276 0
Ethics committee country [1] 316276 0
Australia
Date submitted for ethics approval [1] 316276 0
24/10/2024
Approval date [1] 316276 0
Ethics approval number [1] 316276 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137366 0
A/Prof Karen Hallam
Address 137366 0
RMIT University, 225-245 Plenty Road, Bundoora, Victoria, 3083
Country 137366 0
Australia
Phone 137366 0
+61490391227
Fax 137366 0
Email 137366 0
karen.hallam2@rmit.edu.au
Contact person for public queries
Name 137367 0
Patricia Jackson
Address 137367 0
RMIT University, 225-245 Plenty Road, Bundoora, Victoria, 3083
Country 137367 0
Australia
Phone 137367 0
+61 403798970
Fax 137367 0
Email 137367 0
s3200837@student.rmit.edu.au
Contact person for scientific queries
Name 137368 0
Patricia Jackson
Address 137368 0
RMIT University, 225-245 Plenty Road, Bundoora, Victoria, 3083
Country 137368 0
Australia
Phone 137368 0
+61 403798970
Fax 137368 0
Email 137368 0
s3200837@student.rmit.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.