Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Thomas Jefferson University
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- Beck Anxiety Inventory (BAI)
Study Overview
Brief Summary
The objective of the study is to assess the utility of "Acceptance and Commitment Therapy" (ACT) in which subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors, over "Supportive Psychotherapy" in which subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients. The hypothesis is that six telehealth/webcam sessions of ACT will lead to an improvement in medication and visit compliance, as well as an overall improved sense of well-being and coping skills, particularly as compared with 6 telehealth/webcam sessions of supportive psychotherapy.
Detailed Description
Patients will be consented in the adult cystic fibrosis clinic at Drexel University, Children's Hospital of Philadelphia, University of Pennsylvania Medical Center, St. Christopher's Hospital for Children, Duke University Medical Center, Augusta University and the University of Pittsburgh. For Philadelphia sites (CHOP, Drexel, UPenn, St. Chris), Chelsi Nurse will consent patients to treatment. If at remote sites (Duke Univ Med Center, Augusta Univ, U Pittsburgh) by our local site appointed representatives will consent patients to the study. All CF patients will be approached to assess interest.
If patients are willing to be in the study, they will be given a packet of screening questionnaires (addendum #1). These questionnaires will ask patients: 1) how often participants experience different thoughts and feelings, including some related to having cystic fibrosis; 2) how often participants take their cystic fibrosis medications; 3) their coping style, including how long participants persist in thinking about something that has happened to them; The subject will complete each questionnaire again after 6 appointments (i.e., about 6 weeks later), and again about 3-months after their sixth appointment.
Finally, the investigators hope to learn whether these therapies affect how often subjects take their cystic fibrosis medications, and how this affects their health and wellbeing.
To study this, the investigators will review the number of appointments that are missed six months before enrolling in the program, and six months after completing therapy.The investigators will also review their pulmonary function tests, whether subjects go to the hospital or see their doctor for any extra visits, and the presence of any ongoing symptoms of depression or anxiety. All data will be taken from Allscripts, the Drexel outpatient medical chart. Data will be taken only from the departments of the pi and co-pi's. At UPenn, the social worker at the site will input data into Drexel Redcap through a link sent to them.
Participants will complete 6 sessions of our ACT with CF manualized intervention. Participants will be asked to complete a series of brief questionnaires at the time of consent. If desired, they can take these homes to complete and mail back.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Men and women aged 18 and above.
- •Able to read/understand English.
- •Diagnosis of cystic fibrosis.
- •PHQ-9 score > 4 or GAD-7 score > 4.
Exclusion Criteria
- •History of suicidal attempts or acute suicidal ideation on clinical assessment.
- •Presence of psychotic disorder or symptoms.
- •Pregnant women.
- •Presence of psychiatric disorders that interfere with the participation of 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.
Arms & Interventions
Acceptance and Commitment Therapy
Participants will learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors.
Intervention: Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF) (Behavioral)
Supportive Psychotherapy
Participants will talk about their experiences to date.
Intervention: Supportive Psychotherapy (Treatment as Usual Control) (Behavioral)
Outcomes
Primary Outcomes
Beck Anxiety Inventory (BAI)
Time Frame: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.
This scale is a self-report measure of anxiety.
Beck Depression Inventory-II (BDI-II)
Time Frame: Change at baseline (study entry point, before any sessions have been delivered), after 6 weeks of treatment, 3 months after the end of 6 sessions of treatment.
Widely used indicator of the severity of depression.
Cognitive Fusion Questionnaire (CFQ13)
Time Frame: Beginning of study, after 6 weeks, after 3 months.
Change in cognitive fusion (rigid attachment to one's thoughts as Truth) measures.
Acceptance and Action Questionnaire (AAQ-II)
Time Frame: Beginning of study, after 6 weeks, after 3 months.
Change in acceptance measures.
Secondary Outcomes
- FEV1/ FVC ratio(3 months before study, 3 months after study.)
- The Treatment Adherence Questionnaire-CF(Beginning of study, after 6 weeks, after 3 months.)
- The Cystic Fibrosis Questionnaire-Revised (CFQ-R)(Beginning of study, after 6 weeks, after 3 months.)
Investigators
C. Virginia O'Hayer
Principal Investigator
Thomas Jefferson University
