Preventing Depression and Anxiety: A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention

NCT03992027 | Completed DMC

• 2 other identifiers: 2015P002098FRIEDM18A0
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief Summary

Individuals with Cystic Fibrosis (CF) are at high risk for depression and anxiety, with negative consequences for quality of life, ability to carry out daily CF treatments, and health. CF Foundation and European CF Society guidelines recommend routine screening, treatment, and preventative efforts for depression and anxiety. Cognitive-behavioral therapy (CBT) interventions focused on teaching coping skills have a large evidence-base for prevention and treatment of depression and anxiety, but there are barriers to accessing these interventions for individuals with CF. Drs. Friedman and Georgiopoulos at Massachusetts General Hospital (MGH) have developed a CF-specific CBT-based preventive intervention for depression and anxiety with input from adults with CF and CF healthcare team members, called CF-CBT: A cognitive-behavioral skills-based program to promote emotional well-being for adults with CF, along with a training and supervision program for CF team interventionists. CF-CBT consists of 8 45-minute modules that can be flexibly delivered in the outpatient CF clinic, on the inpatient unit, or by telephone, by multidisciplinary members of the CF care team, minimizing additional cost and burden of care to patients. The goal of this study is to test CF-CBT in 60 adults screening in the mild range on measures of depression and anxiety at 4 CF centers, in a prospective randomized clinical trial comparing the intervention to usual treatment. Participants will be randomized to receive the CF-CBT intervention immediately, or to a 3-month waitlist control followed by intervention. The study will measure depression, anxiety, quality of life, stress, and coping self-efficacy before and after the CF-CBT intervention, and also 3 and 6 months post-intervention.

Conditions

Depression; Anxiety

Keywords

cystic fibrosis; cognitive-behavioral therapy; prevention; coping

Outcome Measures

Primary Outcomes (2)

• Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)

  The PHQ-9 consists of nine questions measuring frequency of depressive symptoms, rated on a Likert scale from 0 "not at all" to 3 "nearly every day," with total score ranging 0-27. Clinical severity scores have been established with scores of 5, 10, 15, and 20 representing cut-off scores for mild, moderate, moderately severe, and severe depression, respectively.

  3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms

• Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)

  The GAD-7 is a 7-item measure of symptoms of anxiety. Likert scale ratings allow total scores of 0-21. Scores of 5, 10, and 15 correspond to severity ratings of mild, moderate and severe anxiety.

  3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms

Secondary Outcomes (6)

• Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items

  Immediately post-intervention

• Change from baseline in Perceived Stress measured by the Perceived Stress Scale (PSS)

  3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms

• Change from baseline in Cystic Fibrosis Health-Related Quality of Life measured by the adult/teen version of the Cystic Fibrosis Questionnaire-Revised (CFQ-R).

  3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms

• Change from baseline in Coping Self-Efficacy measured by the CF Coping Self-Efficacy Measure developed for this study

  3 months (Baseline to Pre-intervention) for the waitlist control group; immediately post-intervention (2 to 3 months from pre-CBT assessment) for both arms; 3 months and 6 months post-intervention for both arms

• Feasibility of the intervention will be indicated by Rate of Attrition, or rate of drop-out or non-completion of the CF-CBT program once enrolled

  From baseline to post-intervention (2 to 3 months for the immediate intervention arm; 5 to 6 months for the waitlist arm)

Study Arms (2)

Immediate CF-CBT Intervention

EXPERIMENTAL

This group will enter immediately into the 8-session cystic fibrosis-specific cognitive-behavioral intervention program (CF-CBT).

Behavioral: CF-CBT: A Cognitive-Behavioral Skills-Based Program to Promote Emotional Well-Being for Adults wtih Cystic Fibrosis

Waitlist control

OTHER

This group will enter into the same 8-session cystic fibrosis-specific cognitive-behavioral intervention program (CF-CBT) 3 months after enrollment.

Behavioral: Waitlist Control

Interventions

CF-CBT: A Cognitive-Behavioral Skills-Based Program to Promote Emotional Well-Being for Adults wtih Cystic Fibrosis BEHAVIORAL

CF-CBT is an 8-session program introducing cognitive-behavioral coping skills for managing stress, and for prevention and treatment of anxiety and depression. The content of the program was developed to address stressors related to coping with cystic fibrosis. Participants will receive a patient workbook, and meet with a trained member of the CF team (interventionist) who will guide them through learning and practicing coping skills during 8 weekly sessions.

Immediate CF-CBT Intervention

Waitlist Control BEHAVIORAL

Participants receive usual care for 3 months followed by CF-CBT. CF-CBT is an 8-session program introducing cognitive-behavioral coping skills for managing stress, and for prevention and treatment of anxiety and depression. The content of the program was developed to address stressors related to coping with cystic fibrosis. Participants will receive a patient workbook, and meet with a trained member of the CF team (interventionist) who will guide them through learning and practicing coping skills during 8 weekly sessions.

Waitlist control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of CF
• depression and anxiety scores on the PHQ-9 and/or GAD-7 screening measures in the mild but not moderate or severe range (scores are \> 4 and ≤ 9)
• Able to speak and read English

You may not qualify if:

• Presenting an acute safety risk to self or others despite self-reporting of mild (subclinical) depression or anxiety scores on routine screening at baseline. Those reporting suicidal intent with or without specific plan will be excluded from the study. These individuals will be referred for urgent/emergent further assessment and treatment as clinically indicated.
• Participation in concomitant formal cognitive-behavioral therapy at baseline

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Cystic Fibrosis Foundation: collaborator
• DeltaQuest Foundation, Inc.: collaborator
• University at Buffalo: collaborator
• University of Kansas Medical Center: collaborator
• Stanford University: collaborator

Study Sites (4)

Stanford University

Palo Alto, California, 94304, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University at Buffalo

Buffalo, New York, 14260, United States

Location

MeSH Terms

Conditions

Depression; Anxiety Disorders; Cystic Fibrosis

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Deborah Friedman, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Anna Georgiopoulos, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychologist

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 19, 2019
• Study Start: July 22, 2019
• Primary Completion: October 31, 2022
• Study Completion: October 31, 2022
• Last Updated: July 25, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)