ACT With CF Self-Help Toolkit
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older
Existing diagnosis of cystic fibrosis
PHQ-9 score >4 or GAD-7 score >4
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
ACT with CF Self-Help Toolkit
BehavioralThe 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 interventionParticipants in the waitlist condition will wait for six weeks before receiving the ACT with CF Self-Help Toolkit
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Immediate TreatmentExperimental treatment 1 intervention
Group B: WaitlistOther 2 interventions
Trial outcomes
Primary outcomes
1
Anxiety
Anxiety as measured by the Beck Anxiety Inventory (Range 0-63), with higher values indicating higher anxiety.
Time frame
at each time point (baseline, 6 weeks, 3 months)2
Depression
Depression as measured by the Beck Depression Inventory II (Range 0-63), with higher values indicating more severe depression symptoms.
Time frame
at each time point (baseline, 6 weeks, 3 months)3
Psychological Flexibility
Psychological flexibility as measured by the Acceptance and Action Questionnaire II (Range 7-49), with higher values indicating less flexibility.
Time frame
at each time point (baseline, 6 weeks, 3 months)4
Cognitive Fusion
Cognitive fusion as measured by the Cognitive Fusion Questionnaire 13 (Range 7-91), with higher values indicating more intense cognitive fusion.
Time frame
at each time point (baseline, 6 weeks, 3 months)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Thomas Jefferson University
Lead sponsor
Boomer Esiason Foundation
Collaborator
Source ClinicalTrials.gov