RecruitingNot Applicable

ACT With CF Self-Help Toolkit

United States60 participantsStarted 2026-01-20

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Anxiety

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

Depression

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

Psychological Flexibility

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

Cognitive Fusion

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

Values-Based Living

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

Trial details

NCT IDNCT07436351

SponsorThomas Jefferson University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-04

Contact for this trial

Virginia O'Hayer, PhD

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

View on ClinicalTrials.gov More Cystic Fibrosis (CF) trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Anxiety

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

Depression

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

Psychological Flexibility

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

Cognitive Fusion

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

Values-Based Living

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