Clinical trial NCT06388044: ACT for Infertility: Case Series
Official title: Acceptance and Commitment Therapy for Infertility Patients: A Case Series
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Infertility
Psychological Distress
Acceptance and Commitment Therapy
Psychological Flexibility
Keywords: Infertility
Psychological Flexibility
Acceptance and Commitment Therapy
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptability of the Intervention
timeFrame: Week 6 (Session 6) and week 12 (Session 12).
Secondary outcomes:
measure: Change in Fertility Problem Inventory (FPI)
timeFrame: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
measure: Change in Patient Health Questionnaire 9 (PHQ-9)
timeFrame: PHQ-9: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
measure: Change in Patient Health Questionnaire 2 (PHQ-2)
timeFrame: 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).
measure: Change in Generalized Anxiety Disorder Questionnaire 7 (GAD-7)
timeFrame: GAD-7: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
measure: Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2)
timeFrame: 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).
measure: Change in Modified Differential Emotions Scale (mDES)
timeFrame: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).
measure: Change in Comprehensive Assessment of Acceptance and Commitment Therapy (CompACT-15)
timeFrame: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
measure: Change in Intolerance of Uncertainty (IUS)
timeFrame: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
measure: Change in Valuing Questionnaire (VQ)
timeFrame: Week 1 (Session 1), week 3 (Session 3), week 6 (Session 6), week 9 (Session 9), and week 12 (Session 12).
measure: Change in Values-Based Behavior
timeFrame: All sessions, weeks 1-12.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke North Pavilion
state: North Carolina
Study officials:
affiliation: Duke University
name: Rhonda Merwin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
citation: Doyle, M., & Carballedo, A. (2014). Infertility and mental health. Advances in psychiatric treatment, 20(5), 297-303.
citation: 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.
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.
citation: Hayes-Skelton, S. A., & Eustis, E. H. (2020). Experiential avoidance.
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.
citation: Peterson, B. D., & Eifert, G. H. (2011). Using acceptance and commitment therapy to treat infertility stress. Cognitive and Behavioral Practice, 18(4), 577-587.
citation: 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.