Cystic FibrosisNCT05271643
Pilot Study of a CF-specific CBT Intervention for Adolescents
A study testing Cognitive Behavioral Therapy (CBT) in people with Cystic Fibrosis and Depression, run by Massachusetts General Hospital at 3 sites in United States.
Trial summary
The goal of this study is to pilot a new CF-specific cognitive-behavioral therapy intervention (CF-CBT-A) for prevention and treatment of depression and anxiety for adolescents with CF. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Cystic Fibrosis, Depression, Anxiety
- What is being tested?
- Cognitive Behavioral Therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Mar 2022to 17 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Be 12-17 years of age
- Have a diagnosis of CF
- 3. 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 able to speak and read English
- Be willing and able to provide assent
- Have a parent who is willing and able to provide informed consent for their own and adolescent participation
Show all 11Show fewer
- Have a parent who is able to speak and read English; the parent will participate in the study in support of their adolescent during the intervention and complete pre- and post- assessments.
- Subjects will not be excluded for the following reasons:
- CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT. If subjects are medically hospitalized during the course of the study, they may continue to participate in the CBT intervention or follow up visits during or following hospitalization as clinically appropriate.
- A history of more severe depression currently at mild to moderate levels with or without treatment.
- Participation in concomitant psychosocial treatments (with the exception of formal CBT) or psychopharmacologic treatments at baseline, although these concomitant treatments will be tracked and considered in analysis.
Who cannot join
- 1. Any subjects who are deemed to present an acute safety risk to self or others will be excluded. Subjects reporting a positive answer on question 9 on the PHQ-9, dealing with suicidality, will be further assessed for severity and clinical context, including administration of the Columbia Suicide Severity Rating Scale (C-SSRS, Screen Version, Recent; Posner, 2011). Those reporting suicidal intent with or without specific plan (yes to question 4 and/or 5 on the C-SSRS) will be excluded from the study. These individuals will be referred for urgent/emergent further assessment and treatment as clinically indicated.
- 2) Participation in concomitant formal cognitive-behavioral therapy at baseline
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Kansas Medical Center
Kansas City, Kansas, 66160
University at Buffalo
New York, New York, 14260
About this study
Official title: Preventing Depression and Anxiety: a Pilot Study of a Cystic-fibrosis Specific Cognitive-behavioral Therapy Intervention for Adolescents With CF
The goal of this study is to pilot a new CF-specific cognitive-behavioral therapy intervention (CF-CBT-A) for prevention and treatment of depression and anxiety for adolescents with CF. CF-CBT-A is a 10-session program that was developed with input from adolescents with CF and parents and CF care teams to be highly relevant to the unique needs of adolescents with CF. The program will be piloted at 3 U.S. CF centers with 10 to 12 adolescents with cystic fibrosis who have mild to moderately severe symptoms of depression and/or mild to severe symptoms of anxiety. It will be delivered by mental health coordinator members of the participant's CF care team who receive training, with sessions occurring in-person or via telehealth. We will examine feasibility and acceptability of the intervention as indicated by measures of completion, intervention fidelity, and adolescent and parent satisfaction ratings. We will also examine preliminary evidence of effectiveness. If this intervention is successful, symptoms of depression and anxiety and perceived psychological stress will decrease and coping self-efficacy and health-related quality of life (HRQoL) will improve.
- Conditions
- Cystic Fibrosis, Depression, Anxiety
- Being tested
- Cognitive Behavioral Therapy (CBT)
- Medical subject headings
- Cystic Fibrosis, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy (CBT)Behavioural
CF-CBT-A is an 10-session program for adolescents with cystic fibrosis 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 mental health clinician on their CF team who will guide them through learning and practicing coping skills. Parents/guardians involvement will be encouraged. A parent/guardian will attend the baseline and final session, have the opportunity for a mid-program check-in, and receive a workbook of psychoeducational material that parallels the adolescent workbook, featuring tips for supporting their teens, and weekly e-mail communication.
| Study group | Role | What they receive |
|---|---|---|
| CF-CBT-A intervention | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items
TThe 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. Completed by parent and adolescent. Assessed one time immediately post-intervention.
Measured: immediately post-intervention
Feasibility of the intervention will be indicated by Rate of completion of the CF-CBT-A program sessions once enrolled
Rate of complete will be summarized by calculating the percentage of CF-CBT-A sessions completed by participants over the course of the study period.
Measured: From baseline to post-intervention (2-3 months)
Secondary outcomes (5)
Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) - adolescent version
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.
Measured: From baseline to post-intervention (2-3 months)
Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
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.
Measured: From baseline to post-intervention (2-3 months)
Change in Perceived Stress, measured by the PROMIS Pediatric and Parent Proxy Psychological Stress Experiences 8-item short forms
This measure assesses psychological stress reactions (e.g., feeling overwhelmed, perceived lack of control of capacity to manage one's life).5Adolescents will self-report and parents will complete the proxy report about their child, providing another perspective on adolescent adjustment. Both scales use a 7-day recall period and include 8 items rated on a 5-point Likert Scale from "Never" to "Always," (e.g., In the past 7 days, I felt stressed).
Measured: From baseline to post-intervention (2-3 months)
Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
The CFQ-R is a well-established measure of HRQoL, validated in a national, multicenter longitudinal study, and demonstrating consistent associations with health outcomes. A parent proxy version will be administered for adolescent participants ages 12 and 13.
Measured: From baseline to post-intervention (2-3 months)
Change in Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version
A self-report measure of confidence in being able to cope with the daily challenges associated with CF developed with input of people with CF. Confidence in being able to use coping skills targeted by the intervention, including those specific to coping with CF, are rated on a 10-point scale from 'very sure' to 'very unsure'.
Measured: From baseline to post-intervention (2-3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start2 Mar 2022
- Primary completion17 Apr 2024
- Study completion17 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University at Buffalo, University of Kansas Medical Center, Behavioral Health Systems Research
- Responsible party
- Principal investigator, Deborah Friedman, Massachusetts General Hospital
- Investigators
- Deborah M Friedman, PhD, Principal investigator, Massachusetts General Hospital (MGH)Anna M Georgiopoulos, MD, Principal investigator, Massachusetts General Hospital (MGH)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271643
- Sponsor's protocol ID
- 2021P001492
- Status last verified
- Sep 2024
- First submitted
- 28 Feb 2022
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Depression and Anxiety: a Pilot Study of a Cystic-fibrosis Specific Cognitive-behavioral Therapy Intervention for Adolescents With CF
- ClinicalTrials.gov ID
- NCT05271643
- Acronym / sponsor ID
- 2021P001492
- Conditions
- Cystic Fibrosis, Depression, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- University at Buffalo, University of Kansas Medical Center, Behavioral Health Systems Research
- Study start
- 2 Mar 2022 (actual)
- Primary completion
- 17 Apr 2024 (actual)
- Study completion
- 17 Apr 2024 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to pilot a new CF-specific cognitive-behavioral therapy intervention (CF-CBT-A) for prevention and treatment of depression and anxiety for adolescents with CF. CF-CBT-A is a 10-session program that was developed with input from adolescents with CF and parents and CF care teams to be highly relevant to the unique needs of adolescents with CF. The program will be piloted at 3 U.S. CF centers with 10 to 12 adolescents with cystic fibrosis who have mild to moderately severe symptoms of depression and/or mild to severe symptoms of anxiety. It will be delivered by mental health coordinator members of the participant's CF care team who receive training, with sessions occurring in-person or via telehealth. We will examine feasibility and acceptability of the intervention as indicated by measures of completion, intervention fidelity, and adolescent and parent satisfaction ratings. We will also examine preliminary evidence of effectiveness. If this intervention is successful, symptoms of depression and anxiety and perceived psychological stress will decrease and coping self-efficacy and health-related quality of life (HRQoL) will improve.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CF-CBT-A intervention | Experimental | Behavioral: Cognitive Behavioral Therapy (CBT)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. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Be 12-17 years of age
- Have a diagnosis of CF
- 3. 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 able to speak and read English
- Be willing and able to provide assent
Key exclusion criteria (2 listed)
- 1. Any subjects who are deemed to present an acute safety risk to self or others will be excluded. Subjects reporting a positive answer on question 9 on the PHQ-9, dealing with suicidality, will be further assessed for severity and clinical context, including administration of the Columbia Suicide Severity Rating Scale (C-SSRS, Screen Version, Recent; Posner, 2011). Those reporting suicidal intent with or without specific plan (yes to question 4 and/or 5 on the C-SSRS) will be excluded from the study. These individuals will be referred for urgent/emergent further assessment and treatment as clinically indicated.
- 2) Participation in concomitant formal cognitive-behavioral therapy at baseline
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy (CBT)CF-CBT-A is an 10-session program for adolescents with cystic fibrosis 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 mental health clinician on their CF team who will guide them through learning and practicing coping skills. Parents/guardians involvement will be encouraged. A parent/guardian will attend the baseline and final session, have the opportunity for a mid-program check-in, and receive a workbook of psychoeducational material that parallels the adolescent workbook, featuring tips for supporting their teens, and weekly e-mail communication. | Behavioural | CF-CBT-A intervention |
Primary outcome
Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items
Time frame: immediately post-intervention
TThe 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. Completed by parent and adolescent. Assessed one time immediately post-intervention.
Feasibility of the intervention will be indicated by Rate of completion of the CF-CBT-A program sessions once enrolled
Time frame: From baseline to post-intervention (2-3 months)
Rate of complete will be summarized by calculating the percentage of CF-CBT-A sessions completed by participants over the course of the study period.
5 secondary outcomes
Change from baseline in Depressive symptoms measured by the Patient Health Questionnaire-9 (PHQ-9) - adolescent version
Time frame: From baseline to post-intervention (2-3 months)
Change from baseline in Anxiety symptoms measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
Time frame: From baseline to post-intervention (2-3 months)
Change in Perceived Stress, measured by the PROMIS Pediatric and Parent Proxy Psychological Stress Experiences 8-item short forms
Time frame: From baseline to post-intervention (2-3 months)
Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
Time frame: From baseline to post-intervention (2-3 months)
Change in Coping Self-Efficacy, measured by the CF Coping Self-Efficacy Scale - adolescent version
Time frame: From baseline to post-intervention (2-3 months)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Deborah M Friedman, PhD principal investigator
Massachusetts General Hospital (MGH)
Anna M Georgiopoulos, MD principal investigator
Massachusetts General Hospital (MGH)
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy (CBT) in people with Cystic Fibrosis and Depression, run by Massachusetts General Hospital at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment acceptability as measured by item and total score summation on the Client Satisfaction Questionnaire (CSQ-8) with additional study-specific items (time frame: immediately post-intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.