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Health Coaching for Chronic Pain Syndrome

N/A

Recruiting

Led By Lisa Marie McAndrew, 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

rates their activity limitations at least 3 on a 0 to 10 point scale

reports wide-spread pain rated at least 4 on a 0 to 10 point pain bothersome scale

Must not have

severe cognitive impairment

life-threatening condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up post-treatment (12-weeks)

Summary

This trial will test whether health coaching is an effective way to improve the symptoms of Pain-CMI for Veterans.

Who is the study for?

This trial is for Veterans with chronic pain syndrome, specifically Pain-CMI as defined by the Kansas City (Steele) criteria. Participants must experience significant activity limitations and widespread pain. Those with psychotic disorders, severe cognitive impairments, life-threatening conditions, current pregnancy or plans to become pregnant soon are excluded.

What is being tested?

The study is testing whether health coaching can help improve the lives of veterans suffering from chronic multisymptom illness related to pain. It's a personalized approach that aligns with the veteran's own goals and beliefs about their condition.

What are the potential side effects?

Since this trial involves non-pharmaceutical interventions like health coaching and supportive psychotherapy, typical drug side effects are not expected. However, participants may experience emotional discomfort or fatigue during therapy sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I rate my activity limitations as 3 or more on a scale of 0 to 10.

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I experience widespread pain rated at least 4 out of 10.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe difficulty with thinking or memory.

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My condition is life-threatening.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ post-treatment (12-weeks)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~post-treatment (12-weeks)

This trial's timeline: 3 weeks for screening, Varies for treatment, and post-treatment (12-weeks) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Behavioral Response to Illness Questionnaire

Brief Pain Inventory

Illness Perception Questionnaire-Revised

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Health CoachingExperimental Treatment1 Intervention

The 12-session remote health coaching intervention assists Veterans in developing and maintaining health behaviors that meet their life goals. Veterans begin by discussing their symptoms, the impact of their symptoms, and their beliefs about Pain-CMI. Next, the Veteran identifies discrepancies between where they are and where they want to be for 5 lifestyle factors. The first half of treatment focuses on providing education about the 5 lifestyle factors. Veterans are introduced to behavior change/health coaching principles. The major focus is on behavior change and development of long-term healthy habits. During the last session, Veterans develop a long-term plan to maintain behavioral changes after the 12-week program and identify the skills that they can utilize moving forward.

Group II: Supportive PsychotherapyPlacebo Group1 Intervention

Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was ." ) in order to help identify experiences for discussion in session. The control consists of 12 weekly sessions delivered via telephone or video and will be delivered by bachelor's, or master's level providers.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Health Coaching

2018

N/A

~3430

0 / 4Eligibility criteria met