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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)
Must not have
Use of assistive device for walking such as cane or walker
Prescribed supplemental oxygen for activity
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 8 (mid-point), week 16 (post-intervention)- measuring change
Awards & highlights
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.
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.
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.
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I have been diagnosed with COPD and have a history of significant smoking.
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I am 40 years old or older.
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I have significant depression or anxiety.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I use a cane or walker to help me walk.
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I need extra oxygen when I move around.
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I have had a worsening of my COPD in the last month.
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I cannot walk, even with help.
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I am currently seeing a therapist for mental health support.
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I can stand up from a chair in less than 16.7 seconds.
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I couldn't track my steps for at least 8 days in the last two weeks.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 8 (mid-point), week 16 (post-intervention)- measuring change
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 8 (mid-point), week 16 (post-intervention)- measuring change
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Measuring change - Late Life Function and Disability Instrument (LLFDI)
Step Count-measuring change
Secondary study objectives
Anxiety
Exercise Capacity
Patient Health Questionniare-8- measuring change
Trial Design
1Treatment groups
Experimental Treatment
Group I: Step-CBTExperimental Treatment1 Intervention
Participants will complete Step-CBT, an integrative 8-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.
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,647 Previous Clinical Trials
3,360,045 Total Patients Enrolled
Patricia Bamonti, PhDPrincipal InvestigatorVA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
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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
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.
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