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Clinical Trials/NCT04114227
NCT04114227CompletedNot Applicable

Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients

Thomas Jefferson University1 site in 1 country146 target enrollmentStarted: July 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
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

Active Comparator

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

Active Comparator

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

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

C. Virginia O'Hayer

Principal Investigator

Thomas Jefferson University

Study Sites (1)

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