Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID07436351

ACT With CF Self-Help Toolkit for Adults with Cystic Fibrosis to Reduce Anxiety and Depression and Improve Psychological Flexibility

Led by Thomas Jefferson University · Updated on 2026-03-03

60

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

T

Thomas Jefferson University

Lead Sponsor

B

Boomer Esiason Foundation

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness of a self-help version of Acceptance and Commitment Therapy (ACT) called the ACT with CF Self-Help Toolkit for adults living with cystic fibrosis. This therapy aims to reduce anxiety and depression and improve psychological flexibility and value-based living in adults with CF, who are at higher risk for these mental health challenges. The study randomly assigns participants to one of two groups: one receives immediate access to the ACT with CF Self-Help Toolkit, which includes six main modules with short videos designed to help manage difficult feelings and encourage positive behaviors; the other group waits six weeks before receiving access to the toolkit. The treatment is delivered digitally and accessed on participants' smartphones. Participants complete a series of questionnaires at baseline, after six weeks, and again at three months to assess anxiety, depression, psychological flexibility, cognitive fusion, and values-based living. Additional data on medication adherence and lung function will be collected from health records. The study uses repeated measures and statistical models to analyze changes over time, with participant data securely sent for analysis. The total participation involves completing digital assessments and using the self-help toolkit over several months.

CONDITIONS

Brief Title

ACT With CF Self-Help Toolkit

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 18 years or older
  • Existing diagnosis of cystic fibrosis
  • PHQ-9 score greater than 4 or GAD-7 score greater than 4 indicating symptoms of depression or anxiety
Not Eligible

You will not qualify if you...

  • History of suicide attempts or acute suicidal thoughts
  • Presence of psychotic disorder or symptoms
  • Psychiatric disorders that interfere with study participation, as judged by clinicians
  • Medical conditions that interfere with study participation, as judged by clinicians

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (remote, questionnaire-based)

Treatment

Duration - 6 weeks

Participants receive access to the ACT with CF Self-Help Toolkit which includes 6 main modules with short videos designed to help manage anxiety, depression, and improve psychological flexibility and value-based living.

Participants complete questionnaires at baseline, 6 weeks, and 3 months after starting the toolkit

Treatment

Duration - 6 weeks waiting, then 6 weeks treatment

Participants in the waitlist group wait for 6 weeks before starting the ACT with CF Self-Help Toolkit, then use the toolkit for 6 weeks.

Participants complete questionnaires before waiting, at 6 weeks (start of toolkit), 6 weeks after starting the toolkit, and 3 months after treatment

Follow-up

Duration - 3 months after treatment

Participants complete final questionnaires 3 months after completing the treatment to assess long-term effects.

1 remote questionnaire session

Trial Site Locations

Total: 1 location

1

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

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Research Team

V

Virginia O'Hayer, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Frequently Asked Questions

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