Clinical trial NCT04486066: An Evaluation of MBSR and CBT for Veterans With Chronic Pain
Official title: An Evaluation of MBSR and CBT for Veterans With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Pain
Keywords: mindfulness
cognitive behavioral therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-07-24
Enrollment: 217
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: Approximately fifty percent of Veterans report chronic pain. Management of chronic pain is often compounded by other life problems, including depression and posttraumatic stress disorder. Use of opioids for pain management entails risk of harm, and effective non-pharmacologic approaches to chronic pain management are needed. Mindfulness-Based Stress Reduction (MBSR) and group Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) are programs that teach skills to improve functionality and quality of life for people with chronic pain. However, studies of MBSR and the group form of CBT-CP for chronic pain remain limited. In the proposed trial, MBSR will be compared to CBT-CP and usual care, with assessment of pain interference and other outcomes at 6-month follow-up. If MBSR and group CBT-CP are shown to be effective in improving outcomes, it would support use of these modalities for chronic pain.

Detailed description: Background: Pain is one of the most common reasons Veterans seek health care. Mental health conditions (including PTSD, anxiety, and depression) are estimated to co-occur for 30-50% of Veterans with chronic pain. Current recommendations for pain management include an integrative approach informed by the biopsychosocial model. It is increasingly recognized that use of opioids for pain management is associated with risk of harm, yet treatment studies of non-pharmacologic approaches remain limited. Mindfulness-Based Stress Reduction (MBSR) and Cognitive Behavioral Therapy for chronic pain (CBT-CP) teach skills intended to enhance functionality and quality of life in the face of chronic pain. The proposed randomized clinical trial will evaluate if MBSR and CBT-CP each result in improvements in pain interference that are superior to usual care. Two hundred twenty-two Veterans with chronic musculoskeletal pain will be randomized to MBSR, CBT-CP or usual care. Measures pertaining to the primary outcome of pain interference will be collected at baseline, at the post-MBSR/CBT-CP time point, and at 6-month follow-up. In addition, measures of pain intensity, depression, and treatment satisfaction will be applied to more fully characterize the impact of MBSR relative to CBT-CP and usual care. Exploratory analyses will assess if outcomes differ for MBSR and CBT-CP, the impact of the interventions on opioid use and indicators of suicidality, and whether Veteran characteristics assessed at baseline function as treatment moderators. Aims: Primary Aim: Assess if MBSR and CBT-CP each result in greater reductions in the pain interference subscale of the Brief Pain Inventory (BPI) as compared to usual care, from baseline to 6 months post-treatment. Secondary Aim: Evaluate if MBSR and CBT-CP are each superior to usual care in producing improvements in pain severity, treatment satisfaction, and depression. Exploratory Aim 1: Evaluate whether outcomes for patients randomized to MBSR and CBT-CP differ for changes in pain interference, pain severity, depression, and treatment satisfaction. Exploratory Aim 2: Evaluate the impact of MBSR and CBT-CP on utilization of opioid analgesics and markers of suicidality.

Exploratory Aim 3: Evaluate moderators of response to MBSR and CBT-CP to lay the groundwork for identifying Veterans more likely to succeed in one or the other treatment. Potential moderators assessed will include: age, gender, baseline depressive symptoms, anxiety sensitivity, and pain catastrophizing.

Design: A three-arm randomized controlled trial comparing MBSR, CBT-CP and usual care. Participants: 222 Veterans at a large urban VA facility with chronic musculoskeletal pain. Interventions: Group MBSR or group CBT-CP, each 8 weeks in duration. Analyses: Mixed models with assess whether MBSR, CBT-CP each produce greater reductions in outcome variables from baseline to follow-up compared to usual care. Implications: If MBSR and CBT-CP are each shown to be superior to usual care for treatment of chronic pain among Veterans, it would support providing MBSR and CBT-CP for this population.

Eligibility criteria: Inclusion Criteria:

All participants must meet criteria for chronic musculoskeletal pain, defined as:

* musculoskeletal pain of low back
* cervical spine, or extremities (hip, knee, or shoulder)
* pain for at least 3 months
* pain severity (worst or average pain score equal to or greater than 4)(i.e., score of 4 or greater on BPI items 3 or 5) and average pain interference (BPI items 9A-9G) rated equal to or great than 3 of 10 over prior week, as measured using the Brief Pain Inventory (BPI)

Exclusion Criteria:

At baseline, the MINI psychiatric interview will determine psychiatric exclusion criteria:

* uncontrolled psychotic disorder
* current bipolar affective disorder with mania
* current suicidal or homicidal ideation with intent in the last month
* inpatient psychiatric admission within the past month
* severe medical conditions that would limit participation (e.g., Class III or IV heart failure)
* pending back surgery

Additional exclusion criteria include prior formal participation in MBSR or CBT-CP. The investigators will include subjects with Alcohol Use Disorder (AUD; defined by the MINI) but exclude those for whom alcohol use poses a safety threat (defined as current drinking and a past-year history of alcohol-related seizures or delirium tremens). The investigators will also include those with Opioid Use Disorder (OUD) and other Substance Use Disorder (SUD; each defined by the MINI).

Primary outcomes:
measure: Pain Interference Subscale of Brief Pain Inventory (BPI)
timeFrame: 6 months after completing treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Tracy L Simpson, PhD
role: PRINCIPAL_INVESTIGATOR
References: