Clinical trial NCT04157101: Health Coaching for Chronic Multisymptom Illness
Official title: Health Coaching for Chronic Multi-symptom Illness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Pain Predominant Chronic Multisymptom Illness
Keywords: Pain
Veteran
Health Coaching
Clinical Trial
Supportive Psychotherapy
Illness beliefs
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2019-11-08
Enrollment: 260
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clinical Trial
Primary purpose: TREATMENT

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.

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).

Eligibility 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

Primary outcomes:
measure: World Health Organization Disability Assessment Schedule
timeFrame: Post-treatment (12 weeks)
measure: Brief Pain Inventory
timeFrame: post-treatment (12-weeks)
measure: World Health Organization Disability Assessment Schedule
timeFrame: follow up (24 week)
measure: Brief Pain Inventory
timeFrame: follow-up (24 weeks)
Secondary outcomes:
measure: Patient Health Questionnaire-15
timeFrame: post-treatment (12-weeks)
measure: Illness Perception Questionnaire-Revised
timeFrame: post-treatment (12-weeks)
measure: Pain Catastrophizing Scale
timeFrame: post-treatment (12-weeks)
measure: Behavioral Response to Illness Questionnaire
timeFrame: post-treatment (12-weeks)
measure: World Health Organization Disability Assessment Schedule
timeFrame: post-treatment (12-weeks)
measure: Brief Pain Inventory
timeFrame: post-treatment (12-weeks)
Other outcomes:
Locations:
city: East Orange
country: United States
facility: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
state: New Jersey
Study officials:
affiliation: East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
name: Lisa Marie McAndrew, PhD
role: PRINCIPAL_INVESTIGATOR
References: