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Health Coaching for Chronic Multisymptom Illness

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04157101
Recruitment Status : Recruiting
First Posted : November 8, 2019
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Description
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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.

Condition or disease Intervention/treatment Phase
Pain Predominant Chronic Multisymptom Illness Behavioral: Health Coaching Behavioral: Supportive Psychotherapy Not Applicable

Detailed Description:

Purpose:

Chronic pain is one of the most common healthcare issues that Veterans face; it can be very debilitating as well as difficult to treat. Pain Predominant Chronic Multi-symptom Illness (CMI) (e.g., fibromyalgia) is a particularly debilitating and treatment-resistant chronic pain condition and a presumptive service-connected condition for Veterans who deployed to the Gulf region from 1990-2021 (VA Benefits Administration, 2018). There is an urgent need for evidence-based non-pharmaceutical treatments for chronic pain. This study will explore the efficacy of remote-delivered health coaching intervention aimed at modifying lifestyle factors of diet, exercise, social connections, stress, and sleep. The control condition will be supportive psychotherapy.

Study Aims:

Primary Aim 1: Determine if remote-delivered health coaching reduces (H1a) disability and (H2a) pain impairment as compared to remote-delivered supportive psychotherapy for Veterans with Pain-CMI. The investigators will also assess the improvement in (H1b) disability and (H2b) pain impairment at the 24-month follow-up.

Primary Aim 2: Determine if health coaching results in more frequent clinically significant improvement in (H3) disability (20%) and (H4) pain impairment (1 point) as compared to supportive psychotherapy.

Secondary Aim 3: Determine if health coaching reduces (H5) physical symptoms, (H6) catastrophizing, (H7) limiting activity and increases (H8) pain control as compared to supportive psychotherapy.

Exploratory Aim 4: Determine if the reduction in (H9) catastrophizing, (H10) limiting activity and increases in (H11) pain control mediate the relationship between health coaching and reductions in disability and pain impairment.

Study Design:

The current proposal is a randomized clinical trial to determine the efficacy of remote-delivered health coaching in reducing disability and pain impairment for Veterans with Pain-CMI as compared to supportive psychotherapy (n=250). Additionally, the investigators will explore mechanisms of change. Participants will complete four assessments at four different timepoints: baseline, 6-week mid treatment (~6 weeks after baseline), post-treatment (~12 weeks after baseline), and 24-week follow-up (~24 weeks after baseline).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Clinical Trial
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigator, assessor, biostatistician
Primary Purpose: Treatment
Official Title: Health Coaching for Chronic Multi-symptom Illness
Actual Study Start Date : April 30, 2020
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Health Coaching
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
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.
Placebo Comparator: Supportive Psychotherapy
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. World Health Organization Disability Assessment Schedule [ Time Frame: Post-treatment (12 weeks) ]
    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.

  2. Brief Pain Inventory [ Time Frame: post-treatment (12-weeks) ]
    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.

  3. World Health Organization Disability Assessment Schedule [ Time Frame: follow up (24 week) ]
    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.

  4. Brief Pain Inventory [ Time Frame: follow-up (24 weeks) ]
    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.


Secondary Outcome Measures :
  1. Patient Health Questionnaire-15 [ Time Frame: post-treatment (12-weeks) ]
    Patient Health Questionnaire (PHQ-15). The PHQ-15 measures physical symptoms and is scored from 0-30 with higher scores = worse symptom burden. The PHQ-15 was validated on a sample of 6,000 and found to be reliable, valid and responsive to change.

  2. Illness Perception Questionnaire-Revised [ Time Frame: post-treatment (12-weeks) ]
    Illness Perception Questionnaire-Revised (IPQ-R).17 Perceived control beliefs will be measured by the IPQ-R. The IPQ-R measures a broad range of illness beliefs, including severity of illness consequences, chronicity, and controllability of illness. The IPQ has been found to be reliable and valid among patients with CMI, predictive of outcomes and responsive to clinical intervention. We will use the control subscale where higher scores = greater perceived control.

  3. Pain Catastrophizing Scale [ Time Frame: post-treatment (12-weeks) ]
    The Pain Catastrophizing Scale (PCS). Catastrophizing will be measured by the PCS. The PCS is a 13-item measure of the degree of pain catastrophizing. The PCS is reliable, valid, predictive of outcomes and responsive to clinical intervention. The PCS is scored on a scale of 0-52 with higher = worse catastrophizing.

  4. Behavioral Response to Illness Questionnaire [ Time Frame: post-treatment (12-weeks) ]
    Behavioral Response to Illness Questionnaire. Limiting behaviors will be assessed with the BRIQ which measures behavioral responses to CMI. The BRIQ has four subscales: limiting behaviors, all or nothing behaviors, practical support and emotional support. The BRIQ is reliable, valid and predicts onset of CMI. We will use the limiting behaviors and all or nothing subscales where higher is more limiting and all or nothing behaviors respectively.

  5. World Health Organization Disability Assessment Schedule [ Time Frame: post-treatment (12-weeks) ]
    World Health Organization Disability Assessment Schedule (WHO-DAS 2.0). We will compare the % who decrease by 20% between arms. The WHO-DAS 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.

  6. Brief Pain Inventory [ Time Frame: post-treatment (12-weeks) ]
    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. The BPI interference scale is 7 items scored from 0-10 with higher = greater interference.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • life-threatening condition,
  • severe cognitive impairment
  • psychotic disorder, pregnant
  • plans to become pregnant in the next year
  • suicidal intent
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04157101


Contacts
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Contact: Lisa M McAndrew, PhD (862) 400-3317 Lisa.Mcandrew@va.gov

Locations
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United States, New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ Recruiting
East Orange, New Jersey, United States, 07018
Contact: Carmelen B Chiusano, MPA    (973) 676-1000 ext 2220    carmelen.chiusano@va.gov   
Contact: Kevin D Beck, PhD    (973) 676-1000    Kevin.Beck@va.gov   
Principal Investigator: Lisa Marie McAndrew, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Lisa Marie McAndrew, PhD East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
More Information
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT04157101    
Other Study ID Numbers: F3254-R
First Posted: November 8, 2019    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Pain
Veteran
Health Coaching
 Clinical Trial
Supportive Psychotherapy
Illness beliefs