Your session is about to expire
← Back to Search
Cognitive Behavioral Therapy for COPD and Emotional Distress
N/A
Recruiting
Led By Patricia Bamonti, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Competent to provide informed consent
Clinical diagnosis of COPD defined as either the ratio of FEV1 to forced vital capacity < 0.70 or prior documentation of FEV1/FVC ratio of < 0.70 and clinical evidence of COPD (defined as > 10 pack-year cigarette smoking history, dyspnea, or on bronchodilators)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6, week 15- measuring change
Awards & highlights
Study Summary
This trial will test a new physical and mental health intervention for Veterans with COPD, emotional distress, and low physical activity. The intervention will be delivered via VA Video Connect.
Who is the study for?
Veterans over 40 with COPD, experiencing depression or anxiety, and not meeting physical activity guidelines. They must have internet access, be able to attend VA sessions, communicate in English, consent to audio recording and wear a Fitbit. Excluded are those highly active or engaged in other exercise studies, needing walking aids or oxygen for activity.Check my eligibility
What is being tested?
The trial is developing an integrated intervention combining physical activity and mental health support for veterans with COPD who also suffer from emotional distress. Delivered via video connect, it aims to improve both COPD outcomes and mental well-being.See study design
What are the potential side effects?
As this is a non-drug intervention focusing on physical activity and cognitive-behavioral therapy (Step-CBT), typical medication side effects are not expected. However, participants may experience discomfort related to increased physical activity.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I understand and can agree to the study's procedures and risks.
Select...
I have been diagnosed with COPD and have a history of significant smoking.
Select...
I am 40 years old or older.
Select...
I have significant depression or anxiety.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 6, week 15- measuring change
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6, week 15- measuring change
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Measuring change - Late Life Function and Disability Instrument (LLFDI)
Step Count-measuring change
Secondary outcome measures
Anxiety
Exercise Capacity
Patient Health Questionniare-9- measuring change
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Step-CBTExperimental Treatment1 Intervention
Participants will complete Step-CBT, an integrative 10-week physical activity and cognitive behavioral therapy (CBT) intervention, delivered by a licensed clinical psychologist. Sessions will take place once per week for 60 minutes using VA Video Connect. Each session will include core components 1) Reviewing physical activity goals, prescribing new step count goal, and problem-solving barriers and 2) The weekly CBT intervention module.
Group II: Usual careActive Control1 Intervention
Participants are assigned to wait-list control
Find a Location
Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,610 Previous Clinical Trials
3,305,136 Total Patients Enrolled
Patricia Bamonti, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I use a cane or walker to help me walk.I understand and can agree to the study's procedures and risks.I have been diagnosed with COPD and have a history of significant smoking.I need extra oxygen when I move around.I have had a worsening of my COPD in the last month.I cannot walk, even with help.I can attend study appointments at the VA.I am currently seeing a therapist for mental health support.I am 40 years old or older.I can stand up from a chair in less than 16.7 seconds.I couldn't track my steps for at least 8 days in the last two weeks.I have significant depression or anxiety.
Research Study Groups:
This trial has the following groups:- Group 1: Step-CBT
- Group 2: Usual care
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.
Are there available positions in this trial for participants?
"Affirmative. The information documented on clinicaltrials.gov confirms that this trial is currently recruiting volunteers, with the first posting of it being November 2nd 2021 and its most recent update occuring in September 2022. 48 participants must be enrolled from a single site."
Answered by AI
How many participants have signed up to partake in this clinical research?
"Affirmative, clinicaltrials.gov reports that this medical research is actively recruiting volunteers which was first posted on November 2nd 2021 and last modified on September of 2022. This study requires 48 patients to be enrolled at a single site."
Answered by AI
Who else is applying?
What state do they live in?
Massachusetts
How old are they?
18 - 65
What site did they apply to?
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
What portion of applicants met pre-screening criteria?
Met criteria
Why did patients apply to this trial?
To find alternative help.
PatientReceived 2+ prior treatments
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger