ACT for Infertility: Case Series

NCT06388044 | Completed

• 1 other identifier: PRO00115010
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility; Psychological Distress; Acceptance and Commitment Therapy; Psychological Flexibility

Keywords

Infertility; Psychological Flexibility; Acceptance and Commitment Therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Change in Fertility Problem Inventory (FPI)

  Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).

• Change in Patient Health Questionnaire 9 (PHQ-9)

  PHQ-9: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).

• Change in Patient Health Questionnaire 2 (PHQ-2)

  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)

  GAD-7: Week 1 (Session 1), week 6 (Session 6), and week 12 (session 12).

• Change in Generalized Anxiety Disorder Questionnaire 2 (GAD-2)

  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).

Study Arms (1)

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.

Behavioral: Acceptance and Commitment Therapy

Interventions

Acceptance and Commitment Therapy BEHAVIORAL

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.

Acceptance and Commitment Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• are at least 18 years old
• have a diagnosis of infertility
• speak English
• are not already participating in individual therapy.

You may not qualify if:

• endorse current suicidality and/ or self-harming behavior
• current psychosis symptoms
• and/ or current substance use

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke North Pavilion

Durham, North Carolina, 27705, United States

Location

Related Publications (9)

• 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.

  PMID: 32690514 BACKGROUND

• 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.

  PMID: 27938872 BACKGROUND

• Doyle, M., & Carballedo, A. (2014). Infertility and mental health. Advances in psychiatric treatment, 20(5), 297-303.

  BACKGROUND

• 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.

  PMID: 36191078 BACKGROUND

• 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.

  PMID: 34753757 BACKGROUND

• Hayes-Skelton, S. A., & Eustis, E. H. (2020). Experiential avoidance.

  BACKGROUND

• 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.

  BACKGROUND

• Peterson, B. D., & Eifert, G. H. (2011). Using acceptance and commitment therapy to treat infertility stress. Cognitive and Behavioral Practice, 18(4), 577-587.

  BACKGROUND

• 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.

  PMID: 37403402 BACKGROUND

MeSH Terms

Conditions

Infertility

Interventions

Acceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Rhonda Merwin, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2024
• First Posted: April 29, 2024
• Study Start: June 26, 2024
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)