Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients
Primary Purpose
Cystic Fibrosis
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF)
Supportive Psychotherapy (Treatment as Usual Control)
Sponsored by
About this trial
This is an interventional supportive care trial for Cystic Fibrosis
Eligibility Criteria
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.
Sites / Locations
- Jefferson Center City Clinic for Behavioral Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Acceptance and Commitment Therapy
Supportive Psychotherapy
Arm Description
Participants will learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors.
Participants will talk about their experiences to date.
Outcomes
Primary Outcome Measures
Generalized Anxiety Disorder Questionnaire 7 (GAD-7)
Rapid screening for the presence of a clinically significant anxiety disorder.
Patient Health Questionnaire 9 (PHQ-9)
Use as a screening tool to assist the clinician in making the diagnosis of depression and to quantify depression symptoms and monitor severity.
Beck Anxiety Inventory (BAI)
This scale is a self-report measure of anxiety.
Beck Depression Inventory-II (BDI-II)
Widely used indicator of the severity of depression.
Secondary Outcome Measures
FEV1/ FVC ratio
Change in FEV1/FVC ratio.
Cognitive Fusion Questionnaire (CFQ13)
Change in cognitive fusion (rigid attachment to one's thoughts as Truth) measures.
Acceptance and Action Questionnaire (AAQ-II)
Change in acceptance measures.
Self-Reported Medication Adherence Questionnaire
Participant change in medication adherence.
Participant re-hospitalization and unscheduled office visits secondary to CF exacerbation's.
Participant change in re-hospitalization and unscheduled office visits secondary to CF exacerbation's.
Scheduled CF clinic visits.
Scheduled CF clinic visits kept.
Body Mass Index (BMI)
Change in Body Mass Index (BMI).
Patient rated outcomes measures (PRO) Questionnaire.
Change in patient rated outcomes measures (PRO) including quality of care questionnaire.
Full Information
NCT ID
NCT04114227
First Posted
September 23, 2019
Last Updated
April 10, 2023
Sponsor
Thomas Jefferson University
1. Study Identification
Unique Protocol Identification Number
NCT04114227
Brief Title
Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients
Official Title
Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
July 31, 2023 (Anticipated)
Study Completion Date
July 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Thomas Jefferson University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
These questionnaires will ask participants about: 1) how often they experience different thoughts and feelings, including some related to having cystic fibrosis; 2) how often they take their cystic fibrosis medications; 3) their coping style, including how long they persist in thinking about something that has happened to them.
Participants will complete each questionnaire again after 6 appointments (i.e., about 6 weeks later), and again about 3-months after their sixth appointment.
These questionnaires take about 45 minutes to complete. Participants will also be asked to complete 6 'Zoom' therapy sessions (using a webcam in their own home or on their own tablet/smartphone and HIPAA-compliant Zoom webcam service) of either "Acceptance and Commitment Therapy", in which participants will learn new ways to manage uncomfortable experiences and feelings (e.g., depression, anxiety) and to engage in positive behaviors, or to "Supportive Psychotherapy", in which participants will talk about their experiences to date. The type of therapy that participants get will be chosen by chance, like flipping a coin. Neither subject nor the study doctor will choose what treatment the participant will get. Participants will have an equal chance of being given each therapy. Audio and video recordings will be taken during each 'Zoom' therapy session. Recordings will be kept on password encrypted USB drives and stored in a locked office only accessible to the principal investigator and adherence coder. Finally, the investigators hope to learn whether these therapies affect how often participants take their cystic fibrosis medications, and how this affects their health and wellbeing. To study this, the investigators will review information from medical charts such as the number of appointments that kept, the number of appointments missed, pulmonary function tests, number of hospital or doctor visits, and the presence of any symptoms of depression or anxiety.
Measures administered are as follows:
Page 1-2: Demographics Page 3-6: CFMHWQ: CF Mental Health and Wellness Self-Report Measure. Page 7-8: BDI-II: Beck Depression Inventory-II. Page 9: BAI: The Beck Anxiety Index. Pearson. Page 10-13: CFQ-R: Cystic Fibrosis Questionnaire-Revised. Page 14: Medical Coping Modes Questionnaire. Page 15: CFS: Coping Flexibility Scale. Page 16: My CF Treatments: Treatment Adherence Questionnaire-CF. Page 17-18: ACT Demographics Page 19: CFQ13: Cognitive Fusion Questionnaire. Page 20: Short Grit Scale Page 21: AAQ-II: Acceptance and Action Questionnaire. Page 22-23: Styles of Coping Word-Pairs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
146 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Acceptance and Commitment Therapy
Arm Type
Active Comparator
Arm Description
Participants will learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors.
Arm Title
Supportive Psychotherapy
Arm Type
Active Comparator
Arm Description
Participants will talk about their experiences to date.
Intervention Type
Behavioral
Intervention Name(s)
Acceptance and Commitment Therapy adapted for Cystic Fibrosis (ACT with CF)
Intervention Description
Subjects learn new ways to manage uncomfortable experiences and feelings and to engage in positive behaviors
Intervention Type
Behavioral
Intervention Name(s)
Supportive Psychotherapy (Treatment as Usual Control)
Intervention Description
Subjects talk about their experiences to date in a cohort of adult Cystic Fibrosis patients.
Primary Outcome Measure Information:
Title
Generalized Anxiety Disorder Questionnaire 7 (GAD-7)
Description
Rapid screening for the presence of a clinically significant anxiety disorder.
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.
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
Use as a screening tool to assist the clinician in making the diagnosis of depression and to quantify depression symptoms and monitor severity.
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.
Title
Beck Anxiety Inventory (BAI)
Description
This scale is a self-report measure of anxiety.
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.
Title
Beck Depression Inventory-II (BDI-II)
Description
Widely used indicator of the severity of depression.
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.
Secondary Outcome Measure Information:
Title
FEV1/ FVC ratio
Description
Change in FEV1/FVC ratio.
Time Frame
3 months before study, 3 months after study.
Title
Cognitive Fusion Questionnaire (CFQ13)
Description
Change in cognitive fusion (rigid attachment to one's thoughts as Truth) measures.
Time Frame
Beginning of study, after 6 weeks, after 3 months.
Title
Acceptance and Action Questionnaire (AAQ-II)
Description
Change in acceptance measures.
Time Frame
Beginning of study, after 6 weeks, after 3 months.
Title
Self-Reported Medication Adherence Questionnaire
Description
Participant change in medication adherence.
Time Frame
Beginning of study, after 6 weeks, after 3 months.
Title
Participant re-hospitalization and unscheduled office visits secondary to CF exacerbation's.
Description
Participant change in re-hospitalization and unscheduled office visits secondary to CF exacerbation's.
Time Frame
3 months before study, 3 months after study.
Title
Scheduled CF clinic visits.
Description
Scheduled CF clinic visits kept.
Time Frame
3 months before study, 3 months after study.
Title
Body Mass Index (BMI)
Description
Change in Body Mass Index (BMI).
Time Frame
3 months before study, 3 months after study.
Title
Patient rated outcomes measures (PRO) Questionnaire.
Description
Change in patient rated outcomes measures (PRO) including quality of care questionnaire.
Time Frame
Beginning of study, after 6 weeks, after 3 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Jefferson Center City Clinic for Behavioral Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Acceptance and Commitment Therapy vs. Supportive Psychotherapy With Cystic Fibrosis Patients
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