Recruiting

ACT with CF

Sponsor:

Thomas Jefferson University

Code:

NCT07436351

Conditions

Cystic Fibrosis (CF)

Depressive and Anxiety Disorders

Psychological Flexibility

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ACT with CF Self-Help Toolkit

Waitlist

Study Details

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

Study ID

NCT07436351

Start date

Jan 20, 2026

Status verified date

Feb, 2026

Completion date

Apr, 2027

Anticipated

Primary completion date

Apr, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Study Design

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

ACT with CF Self-Help Toolkit

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

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

Primary outcome measure

  • Anxiety [ Time Frame: at each time point (baseline, 6 weeks, 3 months) ]
  • Depression [ Time Frame: at each time point (baseline, 6 weeks, 3 months) ]
  • Psychological Flexibility [ Time Frame: at each time point (baseline, 6 weeks, 3 months) ]
  • Cognitive Fusion [ Time Frame: at each time point (baseline, 6 weeks, 3 months) ]
  • Values-Based Living [ Time Frame: at each time point (baseline, 6 weeks, 3 months) ]

Central Contacts and Locations

Central contacts

Virginia O'Hayer, PhD

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

Locations

Thomas Jefferson University Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Virginia O'Hayer, PhD

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

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • cystic fibrosis
  • ACT
  • CF
  • chronic illness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-03-03.