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

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03992027

Collaborator

Cystic Fibrosis Foundation (Other), DeltaQuest Foundation, Inc. (Other), University at Buffalo (Other), University of Kansas Medical Center (Other), Stanford University (Other), Nicklaus Children's Hospital f/k/a Miami Children's Hospital (Other)

Enrollment

Locations

Arms

27.3

Anticipated Duration (Months)

Patients Per Site

0.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety	Behavioral: CF-CBT: A Cognitive-Behavioral Skills-Based Program to Promote Emotional Well-Being for Adults wtih Cystic Fibrosis Behavioral: Waitlist Control	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Preventing Depression and Anxiety: A Randomized Controlled Trial of a CF-Specific CBT Intervention

Actual Study Start Date :

Jul 22, 2019

Anticipated Primary Completion Date :

Oct 31, 2021

Anticipated Study Completion Date :

Oct 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Immediate CF-CBT Intervention 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 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.
Other: Waitlist control 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 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.

Arm

Intervention/Treatment

Experimental: Immediate CF-CBT Intervention

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

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.

Other: Waitlist control

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

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.

Outcome Measures

Primary Outcome Measures

Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) [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]
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.
Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7) [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]
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.

Secondary Outcome Measures

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]
The Client Satisfaction Questionnaire (CSQ-8) is an 8-item self-report measure that assesses patient service satisfaction,rated on a 4-point scale from 1=lowest to 4=highest satisfaction. Post-intervention treatment satisfaction will also be assessed with a series of structured and open-ended questions specific to the study intervention. Assessed one time 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]
The PSS is a 10-item measure assessing the degree to which individuals perceive that current demands exceed their abilities to cope
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]
The CFQ-R is a well-established measure of health-related quality of life (HrQoL). The CFQ-R contains 12 subscales, with five scales measuring physical HrQoL (Physical Functioning - 8 items; Eating Disturbances -3 items; Vitality -4 items; Respiratory - 6 items; Digestion -3 items) and seven measuring psychosocial HrQoL (e.g, Health Perceptions -3 items, Treatment Burden -3 items; Emotional Functioning - 5 items; Social Functioning -6 items; Body Image -3 items; Role Functioning - 4-items). Items are rated on 4-point Likert scale with higher scores reflecting better quality of life. Scaled scores are obtained for each subscale.
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]
The CF Coping Self-Efficacy measure includes 25 items and was developed for this study to assess patient-reported confidence in their ability to use CBT coping skills that are introduced in the CF-CBT intervention to manage general stressors and those related to having CF. Each item is rated on a 10-point Likert scale from 10 to 100 from "very uncertain" to "very certain" about the ability to use each skill , with higher scores indicating greater confidence in being able to use coping skills. Mean scores are obtained for each of 5 proposed subscales (Relaxation; Behavioral Activation; Adaptive Thinking/Cognitive Restructuring; Active Coping/Problem-Solving; and CF-Specific Coping).
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)]
Rate of attrition will be summarized by calculating the percentage of CF-CBT sessions completed by participants over the course of the study period. The CF-CBT program consists of 8 sessions, and the proposed sample size of the study will be 60 participants, such that an Attrition Rate of 0% would be calculated if all 480 CF-CBT sessions were completed.
Feasibility of the intervention will also be indicated by Treatment Fidelity, measured as percent adherence to general and CF-CBT session-specific objectives. [2 years and 3 months (Over the course of the study period)]
Treatment Fidelity will be rated independently for a random 20% of CF-CBT sessions. Each session that is rated will have a general objectives and session-specific objectives rating. The general objectives rating includes 6 items rated on a 6-point Likert scale from "poor/not at all" to "Excellent," with total score ranging from 0-36. Session-specific objectives will include between 5 and 7 items that are dichotomous indicating whether or not (yes/no) a specific objective was met. A percentage of the possible total will be calculated for both general and session-specific objectives for each rated session. All CF-CBT sessions will be recorded so that a random 20% may be independently rated. The initial 8 sessions for each newly trained interventionist will be excluded from analysis.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Stanford University	Palo Alto	California	United States	94304
2	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
3	Massachusetts General Hospital	Boston	Massachusetts	United States	02114
4	University at Buffalo	Buffalo	New York	United States	14260