Health Coaching for Chronic Multisymptom Illness

VA Office of Research and Development

Status: Completed

Conditions: Pain Predominant Chronic Multisymptom Illness

Treatments: Behavioral: Supportive Psychotherapy; Behavioral: Health Coaching

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT04157101

F3254-R

Details and patient eligibility

About

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.

Full 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).

Enrollment: 260 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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260 participants in 2 patient groups, including a placebo group

Health Coaching

Experimental group

Description:

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.

Treatment:

Behavioral: Health Coaching

Supportive Psychotherapy

Placebo Comparator group

Description:

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:

Behavioral: Supportive Psychotherapy