Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients

NCT04114227 | Completed

• 1 other identifier: 1905007203
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to assess the utility of "Acceptance and Commitment Therapy" (ACT) in which subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors, over "Supportive Psychotherapy" in which subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients. The hypothesis is that six telehealth/webcam sessions of ACT will lead to an improvement in medication and visit compliance, as well as an overall improved sense of well-being and coping skills, particularly as compared with 6 telehealth/webcam sessions of supportive psychotherapy.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (4)

• Beck Anxiety Inventory (BAI)

  This scale is a self-report measure of anxiety.

  Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.

• Beck Depression Inventory-II (BDI-II)

  Widely used indicator of the severity of depression.

  Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.

• Cognitive Fusion Questionnaire (CFQ13)

  Change in cognitive fusion (rigid attachment to one's thoughts as Truth) measures.

  Beginning of study, after 6 weeks, after 3 months.

• Acceptance and Action Questionnaire (AAQ-II)

  Change in acceptance measures.

  Beginning of study, after 6 weeks, after 3 months.

Secondary Outcomes (3)

• FEV1/ FVC ratio

  3 months before study, 3 months after study.

• The Treatment Adherence Questionnaire-CF

  Beginning of study, after 6 weeks, after 3 months.

• The Cystic Fibrosis Questionnaire-Revised (CFQ-R)

  Beginning of study, after 6 weeks, after 3 months.

Other Outcomes (2)

• Generalized Anxiety Disorder Questionnaire 7 (GAD-7)

  Inclusion screening measure

• Patient Health Questionnaire 9 (PHQ-9)

  Inclusion screening measure

Study Arms (2)

Acceptance and Commitment Therapy

ACTIVE COMPARATOR

Participants will learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors.

Behavioral: Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF)

Supportive Psychotherapy

ACTIVE COMPARATOR

Participants will talk about their experiences to date.

Behavioral: Supportive Psychotherapy (Treatment as Usual Control)

Interventions

Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF) BEHAVIORAL

Subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors

Acceptance and Commitment Therapy

Supportive Psychotherapy (Treatment as Usual Control) BEHAVIORAL

Subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients.

Supportive Psychotherapy

Eligibility Criteria

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

You may qualify if:

• Men and women aged 18 and above.
• Able to read/understand English.
• Diagnosis of cystic fibrosis.
• PHQ-9 score \> 4 or GAD-7 score \> 4.

You may not qualify if:

• History of suicidal attempts or acute suicidal ideation on clinical assessment.
• Presence of psychotic disorder or symptoms.
• Pregnant women.
• Presence of psychiatric disorders that interfere with the participation of the study, judged by the study or treating clinician. Presence of other medical conditions that interfere with participation in the study, judged by the study or treating clinician.

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Jefferson Center City Clinic for Behavioral Medicine

Philadelphia, Pennsylvania, 19107, United States

Location

Related Publications (2)

• Smith PJ, Drescher CF, Bruschwein H, Ingle K, Nurse C, O'Hayer CV. Psychological Flexibility, Coping Styles, and Mood Among Individuals With Cystic Fibrosis. Biopsychosoc Sci Med. 2025 May 1;87(4):271-279. doi: 10.1097/PSY.0000000000001387. Epub 2025 Mar 24.

  PMID: 40167140 DERIVED

• O'Hayer CV, Smith PJ, Drescher CF, Bruschwein H, Nurse CN, Kushner HM, Ingle K, Stephen MJ, Hoag JB. ACT with CF: A randomized trial of acceptance and commitment therapy vs supportive psychotherapy for adults with cystic fibrosis. Gen Hosp Psychiatry. 2024 Nov-Dec;91:212-222. doi: 10.1016/j.genhosppsych.2024.11.011. Epub 2024 Nov 26.

  PMID: 39626332 DERIVED

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 23, 2019
• First Posted: October 3, 2019
• Study Start: July 1, 2019
• Primary Completion: July 31, 2023
• Study Completion: October 31, 2023
• Last Updated: April 15, 2024

Record last verified: 2024-04

Locations

US (1)