NCT03992027

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

Completed NA Last updated 25 July 2023

What this trial tests

NA trial testing CF-CBT: A Cognitive-Behavioral Skills-Based Program to Promote Emotional Well-Being for Adults wtih Cystic Fibrosis in Depression in 60 participants. Completed in 31 October 2022.

Timeline

22 July 2019

Primary endpoint
31 October 2022

31 October 2022

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	60
Start date	22 July 2019
Primary completion	31 October 2022
Estimated completion	31 October 2022
Sites	4 locations across United States

Drugs / interventions tested

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

Conditions studied

• Depression — all drugs for Depression →
• Anxiety — all drugs for Anxiety →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Depression or Anxiety. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Psychological interventions for improving adherence to inhaled therapies in people with cystic fibrosis.
   Dawson S, Girling CJ, Cowap L, Clark-Carter D. · · 2023 · cited 6× · PMID 36989170 · DOI 10.1002/14651858.cd013766.pub2