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

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

Interventions

BEHAVIORAL

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

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.

BEHAVIORAL

Waitlist Control

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.

Sponsors & Collaborators

• Cystic Fibrosis Foundation

  collaborator OTHER

• DeltaQuest Foundation, Inc.

  collaborator UNKNOWN

• University at Buffalo

  collaborator OTHER

• University of Kansas Medical Center

  collaborator OTHER

• Stanford University

  collaborator OTHER

• Massachusetts General Hospital

  lead OTHER

Principal Investigators

• Deborah Friedman, PhD · Massachusetts General Hospital

• Anna Georgiopoulos, MD · Massachusetts General Hospital

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-07-22

Primary Completion

2022-10-31

Completion

2022-10-31

Countries

• United States

Study Locations