ACT With CF Self-Help Toolkit

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07436351
Status
Recruiting

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.
  • Waitlist — OTHER
    Participants in the waitlist condition will wait for six weeks before receiving the ACT with CF Self-Help Toolkit

Study Details

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.

Key Dates

Start date
Jan 20, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Immediate Treatment
    These participants will receive access to the toolkit immediately and use it as instructed for the next six weeks.
  • Other: Waitlist
    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.

Primary Outcome Measure

Anxiety [ Time Frame: at each time point (baseline, 6 weeks, 3 months) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107
Virginia O'Hayer, PhD
919-943-6738

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