Health Coaching for Chronic Multisymptom Illness

NCT04157101 | Completed

• 1 other identifier: F3254-R
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

The National Academy of Medicine (NAM) labels chronic pain as one of the most extensive health care issues facing our society with "severe impacts on all aspects of the lives of its sufferers."1 Pain predominant chronic multisymptom illness (Pain-CMI, e.g., fibromyalgia) is a particularly debilitating and presumptive service connected condition for Veterans who deployed to the Gulf region. Health coaching is an appealing potential approach to improve the disability of Pain-CMI because it is personalized to the Veteran's unique goals and beliefs about Pain-CMI and it will be widely available as the VA is rolling out health coaching. The goal of this proposal is to understand if health coaching is also efficacious for a complex pain condition, Pain-CMI.

Conditions

Pain Predominant Chronic Multisymptom Illness

Keywords

Pain; Veteran; Health Coaching; Clinical Trial; Supportive Psychotherapy; Illness beliefs

Outcome Measures

Primary Outcomes (4)

• World Health Organization Disability Assessment Schedule

  World Health Organization Disability Assessment Schedule (WHO-DAS 2.0) measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity. Consistent with IMMPACT, our primary outcomes include a general measure of disability (WHO-DAS) and a pain specific measure. A 20% improvement will be considered clinically significant. The WHO-DAS is scored on a scale of 0-100 with higher scores = worse disability.

  Post-treatment (12 weeks)

• Brief Pain Inventory

  Brief Pain Inventory (BPI). Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. There are 7-items for the pain interference subscale which are scored from 0-10 with higher = worse pain interference.

  post-treatment (12-weeks)

• World Health Organization Disability Assessment Schedule

  World Health Organization Disability Assessment Schedule (WHO-DAS 2.0) measures disability which is due to physical and mental health conditions. The WHO-DAS is a 40-item measure and assesses two underlying constructs: activity limitations and deficits in social integration. The items of the WHODAS have a factor loading on a composite score of 0.82 to 0.98. The WHO-DAS has been found to have high reliability and validity and is scored from 0-100 with higher = worse disability.

  follow up (24 week)

• Brief Pain Inventory

  Brief Pain Inventory (BPI). We will compare the % who have a 1 point improvement between arms. Pain will be assessed using the BPI. The BPI is a 11-item measure of pain severity and interference. The BPI has been recommended as a core measure of clinical trials due to its reliability, validity and responsiveness to clinical intervention. We will use the 7-item interference scale which is scored on a scale of 0-10 with higher = worse pain interference.

  follow-up (24 weeks)

Secondary Outcomes (6)

• Patient Health Questionnaire-15

  post-treatment (12-weeks)

• Illness Perception Questionnaire-Revised

  post-treatment (12-weeks)

• Pain Catastrophizing Scale

  post-treatment (12-weeks)

• Behavioral Response to Illness Questionnaire

  post-treatment (12-weeks)

• World Health Organization Disability Assessment Schedule

  post-treatment (12-weeks)

Study Arms (2)

Health Coaching

EXPERIMENTAL

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.

Behavioral: Health Coaching

Supportive Psychotherapy

PLACEBO COMPARATOR

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.

Behavioral: Supportive Psychotherapy

Interventions

Health Coaching BEHAVIORAL

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.

Health Coaching

Supportive Psychotherapy BEHAVIORAL

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.

Supportive Psychotherapy

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Study Population. Participants will consist of 250 Veterans with Pain-CMI
• CMI meets Kansas City (Steele) definition of CMI
• reports wide-spread pain rated at least 4 on a 0 to 10 point pain bothersome scale
• rates their activity limitations at least 3 on a 0 to 10 point scale

You may not qualify if:

• life-threatening condition,
• severe cognitive impairment
• psychotic disorder, pregnant
• plans to become pregnant in the next year
• suicidal intent

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

East Orange, New Jersey, 07018, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lisa Marie McAndrew, PhD

  East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigator, assessor, biostatistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Clinical Trial

Study Record Dates

• First Submitted: November 6, 2019
• First Posted: November 8, 2019
• Study Start: April 30, 2020
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: April 20, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)