ACT for Infertility: Case Series

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility; Psychological Distress; Acceptance and Commitment Therapy; Psychological Flexibility
• Intervention / Treatment: Behavioral: Acceptance and Commitment Therapy

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Francesca Scheiber, PhD; Phone Number: 9196688696; Email: fs158@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke North Pavilion
      • Contact: Francesca Scheiber, PhD; Phone Number: 919-668-8696; Email: fs158@duke.edu
      • Sub-Investigator: Julia Woodward, PhD
      • Sub-Investigator: Ashley Moskovich, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acceptance and Commitment Therapy; 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.	Behavioral: Acceptance and Commitment Therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).
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).
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).
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).
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).
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).
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).
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).
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).
Change in Values-Based Behavior	Measured by self-reported values of importance.	All sessions, weeks 1-12.

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Rhonda Merwin, PhD, Duke University

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• Hayes-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.

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: April 17, 2024
• First Submitted That Met QC Criteria: April 24, 2024
• First Posted (Actual): April 29, 2024

Study Record Updates

• Last Update Posted (Actual): April 29, 2024
• Last Update Submitted That Met QC Criteria: April 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Acceptance and Commitment Therapy; Infertility; Psychological Flexibility
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: PRO00115010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No