InfertilityNCT06006936
Testing an Evidence-Based Self-Help Program for Infertility-Related Distress in Women
A study testing Coping with Infertility Self-Help Program in people with Infertility and Distress, Emotional, run by University of Regina at 1 site in Canada.
Trial summary
Now affecting one in six couples in Canada, infertility is defined as a lack of conception after 12 or more months of regular, unprotected sexual intercourse. Infertility can result from a number of causes; however, women are responsible for accommodating rigid treatment regimens and carry a disproportionate share of… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Infertility, Distress, Emotional, Mental Health Issue
- What is being tested?
- Coping with Infertility Self-Help Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2023to Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Assigned female at birth
- Experiencing infertility (defined as [a] lack of conception after 12 or more months of regular, unprotected, heterosexual intercourse, or [b] currently undergoing fertility treatments)
- Fluent in English
Who cannot join
- Under the age of 18
Trial locations and contacts
1 site in 1 country.
Canada1 site
University of Regina
Regina, Saskatchewan, S4S 0A2
Jennifer L. Gordon, Ph.D., 306-585-4389, Jennifer.Gordon@uregina.ca
Megan Poulter, B.A. (Hons.), 204-391-9440, MeganPoulter@uregina.ca
About this study
Official title: Testing the Efficacy of the 'Coping With Infertility' Self-Help Program: A Randomized Controlled Trial
Now affecting one in six couples in Canada, infertility is defined as a lack of conception after 12 or more months of regular, unprotected sexual intercourse. Infertility can result from a number of causes; however, women are responsible for accommodating rigid treatment regimens and carry a disproportionate share of the psychological burden associated with infertility. Thirty to forty percent of women presenting for the evaluation of infertility experiencing clinically significant depression or anxiety. Yet access to infertility-specific mental health resources is extremely limited in Canada; current psychological interventions are not specialized to this population and are largely ineffective at reducing distress. Therefore, there is an enormous need to increase the efficacy and accessibility of mental health resources for this population.
To address this need, the 7-week Coping with Infertility (CWI) program was developed in collaboration with women with lived experience with infertility. The CWI program aims to reduce distress related to infertility and was recently tested in a small pilot study, where it was found to be very effective in reducing depression and anxiety and improving quality of life among individuals struggling to get pregnant. The goal of this clinical study is to test the CWI program in adult women experiencing infertility. The main questions it aims to answer are if the CWI program is effective at improving mental health and well-being in women experiencing infertility, and if demographic or lifestyle factors moderate the effect of the treatment. For seven weeks, participants will receive the CWI program and complete online questionnaires and interviews to assess the program's effects on infertility-related distress, quality of life, depressive symptoms, anxiety, and relationship quality. They will then complete these questionnaires biweekly for 16 weeks following the program. Researchers will compare the CWI program to a waitlist/treatment as usual control condition to see if the program reduces psychological distress above and beyond women's ordinary coping strategies. If the program is effective in improving psychological well-being in this clinical study, the researchers will make the program widely and freely available to women throughout Canada and the world.
Read the detailed description
Infertility is associated with severe psychological consequences; psychiatric disorders are common, particularly in women, yet current psychological interventions are not specialized to this population and are largely ineffective. The 7-week Coping with Infertility (CWI) program is a self-help program based on cognitive behaviour therapy that aims to improve mental health in women and individuals assigned female at birth who are experiencing infertility. This study aims to test the efficacy of the CWI program.
In the proposed study, a single-blind randomized controlled trial, participants will be randomly assigned to either the specialized CWI program or a waitlist/treatment as usual control condition using stratified block randomization. Infertility-related distress, quality of life, depression, anxiety, and relationship quality will be assessed at baseline, midway through the program, post-treatment, and biweekly for 16 weeks after treatment. It is expected that participants assigned to the CWI program will show significantly reduced infertility-related distress, depression, and anxiety, and improved quality of life and relationship quality relative to baseline and the waitlist control condition. Moderation analyses will examine potential treatment moderators including sexual orientation and gender identity, as well as cultural background, disability status, and whether participants are pursuing fertility treatments. Participants who complete the CWI program will also provide qualitative feedback on how the program can be improved. The results of this trial could establish the CWI program as an effective short-term therapy option for women experiencing infertility, addressing a significant gap in infertility treatment.
- Conditions
- Infertility, Distress, Emotional, Mental Health Issue
- Being tested
- Coping with Infertility Self-Help Program
- Keywords
- infertility, women, mental health, distress, quality of life, depression, anxiety, relationship quality, randomized controlled trial, intervention, treatment, self-help
- Medical subject headings
- Infertility, Psychological Well-Being, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coping with Infertility Self-Help ProgramBehavioural
The CWI program consists of seven 10-minute videos, each with accompanying homework assignments.
The first module, cognitive restructuring, includes instructions on challenging extreme or unhelpful automatic thoughts. The second module, challenging negative core beliefs, includes looking for patterns in thinking that illustrate core beliefs. The third module features behavioural activation techniques and emphasizes the importance of regular pleasure and skill-based activities. The fourth module highlights coping with grief and factors that contribute to grief, such as individual differences in grieving style. The fifth module supports strengthening relationships through responding to requests for affection and outlines several common relationship mistakes. The sixth module demonstrates how to identify and use values to make decisions and guide behaviour. The seventh module summarizes how thoughts, actions, and interactions can contribute to well-being when experiencing infertility.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Condition | Experimental | This arm will receive the Coping with Infertility intervention. Receives: Behavioral: Coping with Infertility Self-Help Program |
| Waitlist/Treatment as Usual Control Condition | No intervention | This arm will continue with everyday life-including their attempts to conceive. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Fertility-related quality of life will be measured via the 24 items contained within the core FertiQoL scale. Scores range from 0 to 100; participants will be considered to exhibit significantly poorer quality of life if their FertiQoL score is less than or equal to 71.
Measured: 6 months (FertiQoL completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Secondary outcomes (5)
Mean Infertility-Related Distress Scores on the Copenhagen Multi-Centre Psychosocial Infertility - Fertility Problem Stress Scales (COMPI-FPSS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Infertility-related distress will be measured via the nine items contained within the COMPI-FPSS. Scores range from 9 to 38; higher scores indicate greater distress.
Measured: 6 months (COMPI-FPSS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Mean Depression Scores on the Patient Health Questionnaire-9 (PHQ-9), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Depressive symptoms will be measured via the nine items contained within the PHQ-9. Scores range from 0 to 27; participants will be considered to exhibit major depressive disorder if their PHQ-9 score is greater than or equal to 10.
Measured: 6 months (PHQ-9 completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Mean Anxiety Scores on the Generalized Anxiety Disorder-7 (GAD-7), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Anxious symptoms will be measured via the seven items contained within the GAD-7. Scores range from 0 to 21; participants will be considered to exhibit generalized anxiety disorder if their GAD-7 score is greater than or equal to 10.
Measured: 6 months (GAD-7 completed completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Mean Relationship Quality on the Relationship Assessment Scale (RAS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Relationship quality will be measured via the seven items contained within the RAS. Scores range from 7 to 35; higher scores indicate greater relationship stability, satisfaction, and quality while lower scores indicate greater relationship dissatisfaction and distress. Participants will be considered to exhibit relationship dissatisfaction and distress if their average RAS score is less than four.
Measured: 6 months (RAS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Occurrence of Mood and Anxiety Disorders at Baseline, Post-Treatment, and 16 Weeks After Treatment
The presence or absence of major depressive disorder, persistent depressive disorder, generalized anxiety disorder, and panic disorder will be determined using the Computerized Version of the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (NetSCID). Presence of any mood and anxiety disorders will be simultaneously and automatically calculated by the NetSCID system based on the relevant criteria results.
Measured: 6 months (NetSCID completed at enrollment (week 0), post-program (week 8), and 16 weeks after the end of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study startSep 2023 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned to either receive the CWI program or to remain in a treatment-as-usual (TAU) control condition using stratified block randomization. The two arms will be stratified based on whether participants are attempting to conceive naturally or undergoing fertility treatments. Participants in the intervention condition will receive one 10-minute video module from the CWI program every week for seven weeks. Each video module will include a homework assignment encouraging participants to integrate the module content into everyday life. Participants in the TAU control condition will not receive video modules or homework; instead, they will continue with everyday life-including their attempts to conceive-until the conclusion of the study. TAU participants will be offered the intervention following the conclusion of the study.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Regina
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Saskatchewan Health Research Foundation, University of Calgary
- Responsible party
- Principal investigator, Jennifer Gordon, University of Regina
- Investigators
- Jennifer L. Gordon, Ph.D., Principal investigator, Unviersity of Regina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06006936
- Sponsor's protocol ID
- REB #2023-210
- Other IDs
- DCO150GP, 6447
- Status last verified
- Aug 2023
- First submitted
- 17 Aug 2023
- Last updated
- 29 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poulter MML, Wahl TD, Kiviharju MJ, Campbell TS, Gordon JL. Testing the efficacy of a self-guided psychotherapy intervention for infertility-related distress: a randomized controlled trial. Hum Reprod. 2026 Feb 1;41(2):246-261. doi: 10.1093/humrep/deaf237.
PubMed 41401817Gordon JL, Poulter MML, Balsom AA, Campbell TS. Testing an Evidence-Based Self-Help Program for Infertility-Related Distress: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jan 18;13:e52662. doi: 10.2196/52662.
PubMed 38236638
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Efficacy of the 'Coping With Infertility' Self-Help Program: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06006936
- Acronym / sponsor ID
- REB #2023-210
- Conditions
- Infertility, Distress, Emotional, Mental Health Issue
- Keywords
- infertility, women, mental health, distress, quality of life, depression, anxiety, relationship quality
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- University of ReginaUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Saskatchewan Health Research Foundation, University of Calgary
- Study start
- Sep 2023 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 23 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Now affecting one in six couples in Canada, infertility is defined as a lack of conception after 12 or more months of regular, unprotected sexual intercourse. Infertility can result from a number of causes; however, women are responsible for accommodating rigid treatment regimens and carry a disproportionate share of the psychological burden associated with infertility. Thirty to forty percent of women presenting for the evaluation of infertility experiencing clinically significant depression or anxiety. Yet access to infertility-specific mental health resources is extremely limited in Canada; current psychological interventions are not specialized to this population and are largely ineffective at reducing distress. Therefore, there is an enormous need to increase the efficacy and accessibility of mental health resources for this population.
To address this need, the 7-week Coping with Infertility (CWI) program was developed in collaboration with women with lived experience with infertility. The CWI program aims to reduce distress related to infertility and was recently tested in a small pilot study, where it was found to be very effective in reducing depression and anxiety and improving quality of life among individuals struggling to get pregnant. The goal of this clinical study is to test the CWI program in adult women experiencing infertility. The main questions it aims to answer are if the CWI program is effective at improving mental health and well-being in women experiencing infertility, and if demographic or lifestyle factors moderate the effect of the treatment. For seven weeks, participants will receive the CWI program and complete online questionnaires and interviews to assess the program's effects on infertility-related distress, quality of life, depressive symptoms, anxiety, and relationship quality. They will then complete these questionnaires biweekly for 16 weeks following the program. Researchers will compare the CWI program to a waitlist/treatment as usual control condition to see if the program reduces psychological distress above and beyond women's ordinary coping strategies. If the program is effective in improving psychological well-being in this clinical study, the researchers will make the program widely and freely available to women throughout Canada and the world.
Detailed description
Infertility is associated with severe psychological consequences; psychiatric disorders are common, particularly in women, yet current psychological interventions are not specialized to this population and are largely ineffective. The 7-week Coping with Infertility (CWI) program is a self-help program based on cognitive behaviour therapy that aims to improve mental health in women and individuals assigned female at birth who are experiencing infertility. This study aims to test the efficacy of the CWI program.
In the proposed study, a single-blind randomized controlled trial, participants will be randomly assigned to either the specialized CWI program or a waitlist/treatment as usual control condition using stratified block randomization. Infertility-related distress, quality of life, depression, anxiety, and relationship quality will be assessed at baseline, midway through the program, post-treatment, and biweekly for 16 weeks after treatment. It is expected that participants assigned to the CWI program will show significantly reduced infertility-related distress, depression, and anxiety, and improved quality of life and relationship quality relative to baseline and the waitlist control condition. Moderation analyses will examine potential treatment moderators including sexual orientation and gender identity, as well as cultural background, disability status, and whether participants are pursuing fertility treatments. Participants who complete the CWI program will also provide qualitative feedback on how the program can be improved. The results of this trial could establish the CWI program as an effective short-term therapy option for women experiencing infertility, addressing a significant gap in infertility treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either receive the CWI program or to remain in a treatment-as-usual (TAU) control condition using stratified block randomization. The two arms will be stratified based on whether participants are attempting to conceive naturally or undergoing fertility treatments. Participants in the intervention condition will receive one 10-minute video module from the CWI program every week for seven weeks. Each video module will include a homework assignment encouraging participants to integrate the module content into everyday life. Participants in the TAU control condition will not receive video modules or homework; instead, they will continue with everyday life-including their attempts to conceive-until the conclusion of the study. TAU participants will be offered the intervention following the conclusion of the study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Condition | Experimental | Behavioral: Coping with Infertility Self-Help ProgramThis arm will receive the Coping with Infertility intervention. |
| Waitlist/Treatment as Usual Control Condition | No intervention | –This arm will continue with everyday life-including their attempts to conceive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Assigned female at birth
- Experiencing infertility (defined as [a] lack of conception after 12 or more months of regular, unprotected, heterosexual intercourse, or [b] currently undergoing fertility treatments)
- Fluent in English
Key exclusion criteria (1 listed)
- Under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coping with Infertility Self-Help ProgramThe CWI program consists of seven 10-minute videos, each with accompanying homework assignments. The first module, cognitive restructuring, includes instructions on challenging extreme or unhelpful automatic thoughts. The second module, challenging negative core beliefs, includes looking for patterns in thinking that illustrate core beliefs. The third module features behavioural activation techniques and emphasizes the importance of regular pleasure and skill-based activities. The fourth module highlights coping with grief and factors that contribute to grief, such as individual differences in grieving style. The fifth module supports strengthening relationships through responding to requests for affection and outlines several common relationship mistakes. The sixth module demonstrates how to identify and use values to make decisions and guide behaviour. The seventh module summarizes how thoughts, actions, and interactions can contribute to well-being when experiencing infertility. | Behavioural | Intervention Condition |
Primary outcome
Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Time frame: 6 months (FertiQoL completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Fertility-related quality of life will be measured via the 24 items contained within the core FertiQoL scale. Scores range from 0 to 100; participants will be considered to exhibit significantly poorer quality of life if their FertiQoL score is less than or equal to 71.
5 secondary outcomes
Mean Infertility-Related Distress Scores on the Copenhagen Multi-Centre Psychosocial Infertility - Fertility Problem Stress Scales (COMPI-FPSS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Time frame: 6 months (COMPI-FPSS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Mean Depression Scores on the Patient Health Questionnaire-9 (PHQ-9), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Time frame: 6 months (PHQ-9 completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Mean Anxiety Scores on the Generalized Anxiety Disorder-7 (GAD-7), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Time frame: 6 months (GAD-7 completed completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Mean Relationship Quality on the Relationship Assessment Scale (RAS), at Post-Treatment and Biweekly for 16 Weeks Post-Treatment
Time frame: 6 months (RAS completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)
Occurrence of Mood and Anxiety Disorders at Baseline, Post-Treatment, and 16 Weeks After Treatment
Time frame: 6 months (NetSCID completed at enrollment (week 0), post-program (week 8), and 16 weeks after the end of treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2023.
- Derived from this study: PubMed 41401817Poulter MML, Wahl TD, Kiviharju MJ, Campbell TS, Gordon JL. Testing the efficacy of a self-guided psychotherapy intervention for infertility-related distress: a randomized controlled trial. Hum Reprod. 2026 Feb 1;41(2):246-261. doi: 10.1093/humrep/deaf237.
- Derived from this study: PubMed 38236638Gordon JL, Poulter MML, Balsom AA, Campbell TS. Testing an Evidence-Based Self-Help Program for Infertility-Related Distress: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2024 Jan 18;13:e52662. doi: 10.2196/52662.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer L. Gordon, Ph.D. principal investigator
Unviersity of Regina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coping with Infertility Self-Help Program in people with Infertility and Distress, Emotional, run by University of Regina at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jennifer L. Gordon, Ph.D. (306-585-4389, Jennifer.Gordon@uregina.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fertility Quality of Life (FertiQoL) Score, at Mid-Treatment, Post-Treatment and Biweekly for 16 Weeks Post-Treatment (time frame: 6 months (FertiQoL completed midway through the program (week 4), post-program (week 8), then biweekly up to 16 weeks after the end of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06006936, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2023.