ACT With CF Self-Help Toolkit

NCT07436351 | Recruiting

• 1 other identifier: iRISID-2025-0297
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Acceptance and Commitment Therapy (ACT) tailored to meet the needs of adults living with cystic fibrosis (ACT with CF) is a newer form of talk therapy that has been shown to reduce anxiety \& depression and improve psychological flexibility, and value-based living. The investigators are now trying to find out whether a self-help version of this treatment (ACT with CF - Self Help Toolkit) is also effective in reducing anxiety and depression and improving psychological flexibility and value-based living in adults with CF. Adults with cystic fibrosis are at increased risk for anxiety and depression. This study examines whether a patient-facing therapy, ACT with CF - Self Help Toolkit can help to reduce anxiety and depression among adults with CF. This treatment can be accessed on the participant's smartphone.

Conditions

Cystic Fibrosis (CF); Depressive and Anxiety Disorders; Psychological Flexibility

Keywords

cystic fibrosis; ACT; CF; chronic illness

Outcome Measures

Primary Outcomes (5)

• Anxiety

  Anxiety as measured by the Beck Anxiety Inventory (Range 0-63), with higher values indicating higher anxiety.

  at each time point (baseline, 6 weeks, 3 months)

• Depression

  Depression as measured by the Beck Depression Inventory II (Range 0-63), with higher values indicating more severe depression symptoms.

  at each time point (baseline, 6 weeks, 3 months)

• Psychological Flexibility

  Psychological flexibility as measured by the Acceptance and Action Questionnaire II (Range 7-49), with higher values indicating less flexibility.

  at each time point (baseline, 6 weeks, 3 months)

• Cognitive Fusion

  Cognitive fusion as measured by the Cognitive Fusion Questionnaire 13 (Range 7-91), with higher values indicating more intense cognitive fusion.

  at each time point (baseline, 6 weeks, 3 months)

• Values-Based Living

  Values-based living as measured by the Valued Living Questionnaire, multiplying the each pair of importance and alignment ratings for each value and summing each product (Range 1-100), with higher values indicating greater values-aligned action.

  at each time point (baseline, 6 weeks, 3 months)

Study Arms (2)

Immediate Treatment

EXPERIMENTAL

These participants will receive access to the toolkit immediately and use it as instructed for the next six weeks.

Behavioral: ACT with CF Self-Help Toolkit

Waitlist

OTHER

These participants will wait six weeks and be compared to the immediate treatment arm at six weeks before then receiving the treatment over the next six weeks.

Behavioral: ACT with CF Self-Help Toolkit; Other: Waitlist

Interventions

ACT with CF Self-Help Toolkit BEHAVIORAL

The ACT with CF Self-Help Toolkit will include 6 main modules, each with 3 or 4 kernels, which will be short videos, in which participants will learn new ways to manage uncomfortable experiences and feelings (e.g., anxiety, depression) and to engage in positive behaviors. These videos are based on the main interventions in our ACT with CF individual therapy protocol. For example, the first main module focuses on how the participant wants to live their life (Values Clarification Intervention), and the kernels in this module are 1-3 minute video clips demonstrating different ways to figure this out (Card Sort, 70th Birthday exercise, accessing barriers). This intervention is directly adapted from the ACT with CF manual, which has been studied previously in several forms and studies.

Immediate Treatment; Waitlist

Waitlist OTHER

Participants in the waitlist condition will wait for six weeks before receiving the ACT with CF Self-Help Toolkit

Waitlist

Eligibility Criteria

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

You may qualify if:

• years or older
• Existing diagnosis of cystic fibrosis
• PHQ-9 score \>4 or GAD-7 score \>4

You may not qualify if:

• History of suicide attempts or acute suicidal ideation on clinical assessment
• Presence of psychotic disorder or symptoms
• Presence of psychiatric disorders that interfere with participation in 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
• Boomer Esiason Foundation: collaborator

Study Sites (1)

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Cystic Fibrosis; Anxiety Disorders; Chronic Disease

Interventions

Waiting Lists

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; Mental Disorders; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Appointments and Schedules; Organization and Administration; Health Services Administration

Central Study Contacts

Virginia O'Hayer, PhD

CONTACT

919-943-6738; virginia.ohayer@jefferson.edu

Study Design

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

Model Details: The participant will complete each questionnaire again after 6 weeks, and again about 3-months later. Some variation exists in the packets based on timepoint. Participants in the waitlist condition will receive a secondary baseline packet before starting the ACT with CF intervention 6 weeks after induction to the study, after which they will begin treatment. 6 weeks after beginning treatment, all participants will complete another measures packet. All participants will complete their final packet 3 months after treatment.

Study Record Dates

• First Submitted: February 20, 2026
• First Posted: February 27, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Access Criteria: Researchers with clear research plans and purposes for the data will receive access under the discretion of the central study contact.

Locations

US (1)