ACT for Infertility: Case Series

Infertility Clinical Trial

Official title:

Acceptance and Commitment Therapy for Infertility Patients: A Case Series

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06388044
• Other study ID #: PRO00115010
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: April 2025

Study information

• Verified date: April 2024
• Source: Duke University
• Contact: Francesca Scheiber, PhD
• Phone: 9196688696
• Email: fs158[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Duke North Pavilion	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & 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. — 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

Outcome

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.