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

Mass General Brigham

Status: Completed

Conditions: Depression; Anxiety

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03992027

2015P002098

FRIEDM18A0 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Immediate CF-CBT Intervention

Experimental group

Description:

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

Treatment:

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

Waitlist control

Other group

Description:

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

Treatment:

Behavioral: Waitlist Control