InfertilityNCT06388044
ACT for Infertility: Case Series
A study testing Acceptance and Commitment Therapy in people with Infertility and Psychological Distress, run by Duke University at 1 site in United States.
Trial summary
In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infertility, Psychological Distress, Acceptance and Commitment Therapy
- What is being tested?
- Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2024to 30 Dec 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- are at least 18 years old
- have a diagnosis of infertility
- speak English
- are not already participating in individual therapy.
- Exclusion Criteria: Patients will be excluded from the study if they
- endorse current suicidality and/ or self-harming behavior
- current psychosis symptoms
- and/ or current substance use
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acceptance and Commitment Therapy for Infertility Patients: A Case Series
In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT.
Read the detailed description
In this study, the investigators present Acceptance and Commitment Therapy (ACT) as a potentially well-suited intervention for infertility patients, and they highlight mechanisms and processes through which ACT might benefit patients. They present a series of cases in which the therapist uses an ACT approach to treat individuals diagnosed with infertility.
The Duke University Health System includes a fertility clinic, which houses an embedded clinical psychology team. Patients at the fertility center can participate in individual psychotherapy and/ or group psychotherapy as part of their fertility treatment. An interventionist will provide psychotherapy to up to 10 individuals on the therapy waitlist. Patients will be eligible for the study if they: are at least 18 years old, have a diagnosis of infertility, speak English, and are not already participating in individual therapy. Patients will be excluded from the study if they endorse current suicidality and/ or self-harming behavior, current psychosis symptoms, and/ or current substance use.
For those that enroll in the study, patients will complete 12 therapy sessions in the fertility clinic, with sessions lasting between 50 and 60 minutes. Although sessions will vary across individuals, the therapist will aim to target the six core ACT processes in all cases. The therapist will offer both in-person and virtual sessions. Participants will complete a subset of questionnaires at each study session.
- Conditions
- Infertility, Psychological Distress, Acceptance and Commitment Therapy, Psychological Flexibility
- Being tested
- Acceptance and Commitment Therapy
- Keywords
- Infertility, Psychological Flexibility, Acceptance and Commitment Therapy
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acceptance and Commitment TherapyBehavioural
Acceptance and Commitment Therapy (ACT) is a third-wave cognitive behavioral therapy. ACT aims to increase psychological flexibility through six core processes: acceptance, cognitive defusion, present-moment awareness, self as context, values, and committed action.
| Study group | Role | What they receive |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | For those that enroll in the study, the therapist will see patients for 12 therapy sessions in the fertility clinic, with sessions lasting between 50 and 60 minutes. The therapist will offer both in-person and virtual sessions. Receives: Behavioral: Acceptance and Commitment Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the Intervention
Patients will answer several questions about the extent to which they perceive the intervention to be beneficial and acceptable. Patients will answer questions using a 5-point Likert scale, with 1 being 'strongly disagree' and 5 being 'strongly agree.' The investigators will use this information descriptively--for each question, they will describe patient responses by identifying the percentage of patients that responded with each option (e.g., 7 out of 10 patients indicated that they strongly agreed with the following question: [question]).
Measured: Week 6 (Session 6) and week 12 (Session 12).
Secondary outcomes (10)
Change in Fertility Problem Inventory (FPI)
The FPI is a 46-item self-report questionnaire that measures infertility-related stress. It includes a global stress score, as well as additional scores for four constructs: social concern, sexual concern, relationship concern, and need for parenthood. Patients will answer questions using a scale of 1 to 6, with higher scores reflecting greater distress.
Measured: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
Change in Patient Health Questionnaire 9 (PHQ-9)
The PHQ-9 is a 9-item self-report questionnaire that measures symptoms of depression. Participants answer questions using a scale of 0 to 3, with higher scores reflecting more and/ or more severe depression symptoms.
Measured: PHQ-9: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
Change in Patient Health Questionnaire 2 (PHQ-2)
The PHQ-2 is a 2-item self-report questionnaire that measures symptoms of depression. Participants answer questions using a scale of 0 to 3, with higher scores reflecting more and/ or more severe depression symptoms.
Measured: PHQ-2: Weeks 2 (Session 2), 3 (Session 3), 4 (Session 4), 5 (Session 5), 7 (Session 7), 8 (Session 8), 9 (Session 9), 10 (Session 10), and 11 (Session 11).
Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7)
The GAD-7 is a 7-item self-report questionnaire that measures symptoms of generalized anxiety. Participants answer questions using a scale of 0 to 3, with higher scores reflecting more and/ or more severe anxiety symptoms.
Measured: GAD-7: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2)
The GAD-2 is a 2-item self-report questionnaire that measures symptoms of generalized anxiety. Participants answer questions using a scale of 0 to 3, with higher scores reflecting more and/ or more severe anxiety symptoms.
Measured: GAD-2: Weeks 2 (Session 2), 3 (Session 3), 4 (Session 4), 5 (Session 5), 7 (Session 7), 8 (Session 8), 9 (Session 9), 10 (Session 10), and 11 (Session 11).
Change in Modified Differential Emotions Scale (mDES)
The mDES is a 20-item self-report questionnaire that measures the extent to which one has felt a range of emotions, including both negative and positive emotions. It includes a positive emotions score and a negative emotions score. Participants answer questions on a scale of 0 to 4, with higher scores reflecting more of that type of emotion.
Measured: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15)
The CompACT-15 is a 15-item self-report questionnaire that measures several components of psychological flexibility, including openness to experience, behavioral awareness, and valued action. Patients will answer questions using a scale of 0 to 6, with higher scores reflecting greater levels of psychological flexibility.
Measured: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
Change in Intolerance of Uncertainty (IUS)
The IUS is a 27-item self-report questionnaire that measures emotional, cognitive, and behavioral reactions to uncertainty, the consequences of uncertainty, and attempts to control the future. Patients will answer questions using a scale of 1 to 5, with higher scores reflecting greater levels of intolerance.
Measured: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
Change in Valuing Questionnaire (VQ)
The VQ is a 10-item self-report questionnaire that measures the consistency with which an individual's behavior is aligned with his or her values. The VQ includes two constructs: progress and obstruction. Participants will answer questions using a scale of 0 to 6. On the progress subscale, higher scores reflect a greater level of consistency between one's values and behavior. On the obstruction subscale, higher scores reflect a greater level of inconsistency between one's values and behavior.
Measured: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
Change in Values-Based Behavior
Measured by self-reported values of importance.
Measured: All sessions, weeks 1-12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start26 Jun 2024
- Primary completion30 Dec 2025
- Study completion30 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rhonda Merwin, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388044
- Sponsor's protocol ID
- PRO00115010
- Status last verified
- Jan 2026
- First submitted
- 17 Apr 2024
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bright K, Dube L, Hayden KA, Gordon JL. Effectiveness of psychological interventions on mental health, quality of life and relationship satisfaction for individuals and/or couples undergoing fertility treatment: a systematic review and meta-analysis protocol. BMJ Open. 2020 Jul 19;10(7):e036030. doi: 10.1136/bmjopen-2019-036030.
PubMed 32690514Cunha M, Galhardo A, Pinto-Gouveia J. Experiential avoidance, self-compassion, self-judgment and coping styles in infertility. Sex Reprod Healthc. 2016 Dec;10:41-47. doi: 10.1016/j.srhc.2016.04.001. Epub 2016 Apr 8.
PubMed 27938872Doyle, M., & Carballedo, A. (2014). Infertility and mental health. Advances in psychiatric treatment, 20(5), 297-303.
Dube L, Bright K, Hayden KA, Gordon JL. Efficacy of psychological interventions for mental health and pregnancy rates among individuals with infertility: a systematic review and meta-analysis. Hum Reprod Update. 2023 Jan 5;29(1):71-94. doi: 10.1093/humupd/dmac034.
PubMed 36191078Dube L, Nkosi-Mafutha N, Balsom AA, Gordon JL. Infertility-related distress and clinical targets for psychotherapy: a qualitative study. BMJ Open. 2021 Nov 9;11(11):e050373. doi: 10.1136/bmjopen-2021-050373.
PubMed 34753757Hayes-Skelton, S. A., & Eustis, E. H. (2020). Experiential avoidance.
Hayes, S. C., & Hofmann, S. G. (2018). Future directions in CBT and Evidence-based therapy. Process-based CBT: The science and core clinical competencies of cognitive behavioral therapy, 427-435.
Peterson, B. D., & Eifert, G. H. (2011). Using acceptance and commitment therapy to treat infertility stress. Cognitive and Behavioral Practice, 18(4), 577-587.
Schuette SA, Andrade FC, Woodward JT, Smoski MJ. Identifying modifiable factors associated with psychological health in women experiencing infertility. J Health Psychol. 2023 Oct;28(12):1143-1156. doi: 10.1177/13591053231185549. Epub 2023 Jul 4.
PubMed 37403402
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptance and Commitment Therapy for Infertility Patients: A Case Series
- ClinicalTrials.gov ID
- NCT06388044
- Acronym / sponsor ID
- PRO00115010
- Conditions
- Infertility, Psychological Distress, Acceptance and Commitment Therapy, Psychological Flexibility
- Keywords
- Infertility, Psychological Flexibility, Acceptance and Commitment Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 26 Jun 2024 (actual)
- Primary completion
- 30 Dec 2025 (actual)
- Study completion
- 30 Dec 2025 (actual)
- First posted
- 29 Apr 2024 (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.
In the United States, around 19% of reproductive-aged couples suffer from infertility. The psychological distress associated with infertility is well-established; those diagnosed commonly experience depression and anxiety symptoms, diminished quality of life, and relationship dissatisfaction. In the current study, the investigators report on a case series, in which up to 10 infertility patients will receive 12 sessions of Acceptance and Commitment Therapy (ACT). The overarching goal for the current case series is to determine whether ACT might be well-suited for infertility patients experiencing distress. The specific aims are: 1) to describe the components of the intervention that was delivered; 2) to determine the extent to which infertility patients perceive a 12-session ACT intervention beneficial and acceptable; 3) to describe change in mood, stress, and ACT processes across 12 sessions of ACT; and 4) to highlight potential processes through which ACT might promote benefits to the patient by describing how change in mood, stress, and ACT processes relate to each other over the course of 12 sessions of ACT.
Detailed description
In this study, the investigators present Acceptance and Commitment Therapy (ACT) as a potentially well-suited intervention for infertility patients, and they highlight mechanisms and processes through which ACT might benefit patients. They present a series of cases in which the therapist uses an ACT approach to treat individuals diagnosed with infertility.
The Duke University Health System includes a fertility clinic, which houses an embedded clinical psychology team. Patients at the fertility center can participate in individual psychotherapy and/ or group psychotherapy as part of their fertility treatment. An interventionist will provide psychotherapy to up to 10 individuals on the therapy waitlist. Patients will be eligible for the study if they: are at least 18 years old, have a diagnosis of infertility, speak English, and are not already participating in individual therapy. Patients will be excluded from the study if they endorse current suicidality and/ or self-harming behavior, current psychosis symptoms, and/ or current substance use.
For those that enroll in the study, patients will complete 12 therapy sessions in the fertility clinic, with sessions lasting between 50 and 60 minutes. Although sessions will vary across individuals, the therapist will aim to target the six core ACT processes in all cases. The therapist will offer both in-person and virtual sessions. Participants will complete a subset of questionnaires at each study session.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Behavioral: Acceptance and Commitment TherapyFor those that enroll in the study, the therapist will see patients for 12 therapy sessions in the fertility clinic, with sessions lasting between 50 and 60 minutes. The therapist will offer both in-person and virtual sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- are at least 18 years old
- have a diagnosis of infertility
- speak English
- are not already participating in individual therapy.
- Exclusion Criteria: Patients will be excluded from the study if they
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Acceptance and Commitment TherapyAcceptance and Commitment Therapy (ACT) is a third-wave cognitive behavioral therapy. ACT aims to increase psychological flexibility through six core processes: acceptance, cognitive defusion, present-moment awareness, self as context, values, and committed action. | Behavioural | Acceptance and Commitment Therapy |
Primary outcome
Acceptability of the Intervention
Time frame: Week 6 (Session 6) and week 12 (Session 12).
Patients will answer several questions about the extent to which they perceive the intervention to be beneficial and acceptable. Patients will answer questions using a 5-point Likert scale, with 1 being 'strongly disagree' and 5 being 'strongly agree.' The investigators will use this information descriptively--for each question, they will describe patient responses by identifying the percentage of patients that responded with each option (e.g., 7 out of 10 patients indicated that they strongly agreed with the following question: [question]).
10 secondary outcomes
Change in Fertility Problem Inventory (FPI)
Time frame: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
Change in Patient Health Questionnaire 9 (PHQ-9)
Time frame: PHQ-9: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
Change in Patient Health Questionnaire 2 (PHQ-2)
Time frame: PHQ-2: Weeks 2 (Session 2), 3 (Session 3), 4 (Session 4), 5 (Session 5), 7 (Session 7), 8 (Session 8), 9 (Session 9), 10 (Session 10), and 11 (Session 11).
Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7)
Time frame: GAD-7: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2)
Time frame: GAD-2: Weeks 2 (Session 2), 3 (Session 3), 4 (Session 4), 5 (Session 5), 7 (Session 7), 8 (Session 8), 9 (Session 9), 10 (Session 10), and 11 (Session 11).
Change in Modified Differential Emotions Scale (mDES)
Time frame: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15)
Time frame: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
Change in Intolerance of Uncertainty (IUS)
Time frame: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
Change in Valuing Questionnaire (VQ)
Time frame: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
Change in Values-Based Behavior
Time frame: All sessions, weeks 1-12.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 32690514Bright K, Dube L, Hayden KA, Gordon JL. Effectiveness of psychological interventions on mental health, quality of life and relationship satisfaction for individuals and/or couples undergoing fertility treatment: a systematic review and meta-analysis protocol. BMJ Open. 2020 Jul 19;10(7):e036030. doi: 10.1136/bmjopen-2019-036030.
- Background: PubMed 27938872Cunha M, Galhardo A, Pinto-Gouveia J. Experiential avoidance, self-compassion, self-judgment and coping styles in infertility. Sex Reprod Healthc. 2016 Dec;10:41-47. doi: 10.1016/j.srhc.2016.04.001. Epub 2016 Apr 8.
- BackgroundDoyle, M., & Carballedo, A. (2014). Infertility and mental health. Advances in psychiatric treatment, 20(5), 297-303.
- Background: PubMed 36191078Dube L, Bright K, Hayden KA, Gordon JL. Efficacy of psychological interventions for mental health and pregnancy rates among individuals with infertility: a systematic review and meta-analysis. Hum Reprod Update. 2023 Jan 5;29(1):71-94. doi: 10.1093/humupd/dmac034.
- Background: PubMed 34753757Dube L, Nkosi-Mafutha N, Balsom AA, Gordon JL. Infertility-related distress and clinical targets for psychotherapy: a qualitative study. BMJ Open. 2021 Nov 9;11(11):e050373. doi: 10.1136/bmjopen-2021-050373.
- BackgroundHayes-Skelton, S. A., & Eustis, E. H. (2020). Experiential avoidance.
- BackgroundHayes, S. C., & Hofmann, S. G. (2018). Future directions in CBT and Evidence-based therapy. Process-based CBT: The science and core clinical competencies of cognitive behavioral therapy, 427-435.
- BackgroundPeterson, B. D., & Eifert, G. H. (2011). Using acceptance and commitment therapy to treat infertility stress. Cognitive and Behavioral Practice, 18(4), 577-587.
- Background: PubMed 37403402Schuette SA, Andrade FC, Woodward JT, Smoski MJ. Identifying modifiable factors associated with psychological health in women experiencing infertility. J Health Psychol. 2023 Oct;28(12):1143-1156. doi: 10.1177/13591053231185549. Epub 2023 Jul 4.
- 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.
Rhonda Merwin, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acceptance and Commitment Therapy in people with Infertility and Psychological Distress, run by Duke University at 1 site in United States.
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 8 inclusion and 0 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: finished, as of the sponsor's last update on 20 Jan 2026. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the Intervention (time frame: Week 6 (Session 6) and week 12 (Session 12).). 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 NCT06388044, which also lists 9 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 20 Jan 2026; AzTrials last refreshed its copy on 28 Oct 2026.