Clinical trial NCT03992027: Preventing Depression and Anxiety: A Cystic Fibrosis-Specific Cognitive Behavioral Therapy Intervention
Official title: Preventing Depression and Anxiety: A Randomized Controlled Trial of a CF-Specific CBT Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Anxiety
Keywords: cystic fibrosis
cognitive-behavioral therapy
prevention
coping
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Cystic Fibrosis Foundation
name: DeltaQuest Foundation, Inc.
name: University at Buffalo
name: University of Kansas Medical Center
name: Stanford University
First posted: 2019-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 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
measure: Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
timeFrame: 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:
measure: Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items
timeFrame: Immediately post-intervention
measure: Change from baseline in Perceived Stress measured by the Perceived Stress Scale (PSS)
timeFrame: 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
measure: 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).
timeFrame: 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
measure: Change from baseline in Coping Self-Efficacy measured by the CF Coping Self-Efficacy Measure developed for this study
timeFrame: 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
measure: 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
timeFrame: From baseline to post-intervention (2 to 3 months for the immediate intervention arm; 5 to 6 months for the waitlist arm)
measure: Feasibility of the intervention will also be indicated by Treatment Fidelity, measured as percent adherence to general and CF-CBT session-specific objectives.
timeFrame: 2 years and 3 months (Over the course of the study period)
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: Kansas City
country: United States
facility: University of Kansas Medical Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Buffalo
country: United States
facility: University at Buffalo
state: New York
Study officials:
affiliation: Massachusetts General Hospital
name: Deborah Friedman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Massachusetts General Hospital
name: Anna Georgiopoulos, MD
role: PRINCIPAL_INVESTIGATOR
References: