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Cognitive Behavioral Therapy (CBT) for Cystic Fibrosis
N/A
Recruiting
Led By Deborah M Friedman, PhD
Research Sponsored by Massachusetts General Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Have depression symptom scores on the PHQ-A in the mild to moderately severe range (> 4 and ≤ 19), but not in the severe range, and/or anxiety scores on the GAD-7 from mild to severe range (5 to 21)
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to post-intervention (2-3 months)
Awards & highlights
Study Summary
This trial is testing a new cognitive-behavioral therapy intervention specifically for adolescents with CF who have mild to moderate symptoms of depression or anxiety. The goal is to improve symptoms, coping self-efficacy, and HRQoL.
Eligible Conditions
- Cystic Fibrosis
- Depression
- Anxiety
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
You have mild to moderate symptoms of depression or anxiety, but not severe symptoms.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from baseline to post-intervention (2-3 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to post-intervention (2-3 months)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of the intervention will be indicated by Rate of completion of the CF-CBT-A program sessions once enrolled
Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items
Secondary outcome measures
Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) - adolescent version
Change in Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version
+2 moreSide effects data
From 2018 Phase 4 trial • 95 Patients • NCT0104127418%
Weight increase
10%
Tachycardia
6%
Psychiatric Hospitalization
6%
Hypertension
6%
Loss of libido
4%
Concentration impaired
4%
Appetite increase
4%
Memory impaired
4%
Rash
4%
Restlessness
4%
Amenorrhea
2%
Dizziness upon standing
2%
Cellulitis
2%
Anorgasmia
2%
Akathisia
2%
Appetite decrease
2%
Apathy
2%
Sleep disturbed
2%
Blurred vision
2%
Hot flashes
2%
Medical Hospitalization
2%
Drug-related hospitalization
2%
Drooling
2%
Drug abuse
2%
Fatigue
2%
Hiccup
2%
Hit by a motorcycle
2%
Hurt when riding a bike
2%
Mental activity decreased
2%
Muscle twitch
2%
Sleeplessness
2%
Pneumonia
2%
Nightmares
2%
Teeth grating
2%
Incarceration
2%
Sensory hallucinations
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Citalopram
Trial Design
1Treatment groups
Experimental Treatment
Group I: CF-CBT-A interventionExperimental Treatment1 Intervention
Participants will meet with a therapist, a mental health provider on their cystic fibrosis care team who has received training in CF-CBT-A, for a baseline interview and introduction plus 9 weekly sessions of CF-CBT-A.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Cognitive Behavioral Therapy (CBT)
2008
Completed Phase 4
~3620
Find a Location
Who is running the clinical trial?
Massachusetts General HospitalLead Sponsor
2,918 Previous Clinical Trials
13,192,823 Total Patients Enrolled
8 Trials studying Cystic Fibrosis
1,415 Patients Enrolled for Cystic Fibrosis
University at BuffaloOTHER
130 Previous Clinical Trials
98,872 Total Patients Enrolled
1 Trials studying Cystic Fibrosis
85 Patients Enrolled for Cystic Fibrosis
University of Kansas Medical CenterOTHER
458 Previous Clinical Trials
169,076 Total Patients Enrolled
7 Trials studying Cystic Fibrosis
209 Patients Enrolled for Cystic Fibrosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have mild to moderate symptoms of depression or anxiety, but not severe symptoms.You are 12-17 years of age.You must be able to speak and read English.You have a parent who is willing and able to provide informed consent for their own and adolescent participation.You have symptoms of depression and/or anxiety that are in the mild to moderately severe range.
Research Study Groups:
This trial has the following groups:- Group 1: CF-CBT-A intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who else is applying?
What state do they live in?
Missouri
How old are they?
18 - 65
What site did they apply to?
University of Kansas Medical Center
What portion of applicants met pre-screening criteria?
Met criteria
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