NCT07436351 · Thomas Jefferson University
ACT With CF Self-Help Toolkit
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
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.
OTHER
Waitlist
Participants in the waitlist condition will wait for six weeks before receiving the ACT with CF Self-Help Toolkit
Primary outcome measures
Anxiety
Time frame: at each time point (baseline, 6 weeks, 3 months)
Anxiety as measured by the Beck Anxiety Inventory (Range 0-63), with higher values indicating higher anxiety.
Depression
Time frame: at each time point (baseline, 6 weeks, 3 months)
Depression as measured by the Beck Depression Inventory II (Range 0-63), with higher values indicating more severe depression symptoms.
Psychological Flexibility
Time frame: at each time point (baseline, 6 weeks, 3 months)
Psychological flexibility as measured by the Acceptance and Action Questionnaire II (Range 7-49), with higher values indicating less flexibility.
Cognitive Fusion
Time frame: at each time point (baseline, 6 weeks, 3 months)
Cognitive fusion as measured by the Cognitive Fusion Questionnaire 13 (Range 7-91), with higher values indicating more intense cognitive fusion.
Values-Based Living
Time frame: at each time point (baseline, 6 weeks, 3 months)
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Philadelphia, Pennsylvania
Collaborators
Boomer Esiason Foundation
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations