Infertility Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 10 |
Est. completion date | April 2025 |
Est. primary completion date | April 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: Patients will be eligible if they - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Duke North Pavilion | Durham | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Duke University |
United States,
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. — View Citation
Cunha 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. — View Citation
Doyle, 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. — View Citation
Dube 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. — View Citation
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.
Hayes-Skelton, S. A., & Eustis, E. H. (2020). Experiential avoidance.
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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]). | Week 6 (Session 6) and week 12 (Session 12). | |
Secondary | 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. | Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12). | |
Secondary | 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. | PHQ-9: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12). | |
Secondary | 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. | 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). | |
Secondary | 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. | GAD-7: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12). | |
Secondary | 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. | 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). | |
Secondary | 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. | Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12). | |
Secondary | 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. | Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12). | |
Secondary | 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. | Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12). | |
Secondary | 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. | Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12). | |
Secondary | Change in Values-Based Behavior | Measured by self-reported values of importance. | All sessions, weeks 1-12. |
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