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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

No Placebo-Only Group

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 below

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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:

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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

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 8 (mid-point), week 16 (post-intervention)- measuring change for reporting.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 11Eligibility criteria met