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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 below
Select...
You have mild to moderate symptoms of depression or anxiety, but not severe symptoms.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to post-intervention (2-3 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to post-intervention (2-3 months) for reporting.

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 more

Side effects data

From 2018 Phase 4 trial • 95 Patients • NCT01041274
18%
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

Cognitive Behavioral Therapy (CBT) Clinical Trial Eligibility Overview. Trial Name: NCT05271643 — N/A
Cystic Fibrosis Research Study Groups: CF-CBT-A intervention
Cystic Fibrosis Clinical Trial 2023: Cognitive Behavioral Therapy (CBT) Highlights & Side Effects. Trial Name: NCT05271643 — N/A
Cognitive Behavioral Therapy (CBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05271643 — N/A

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
~4 spots leftby Mar 2025