Clinical trial NCT04118283: Assessment and Treatment for Chronic Pain in Veterans With Serious Mental Illness
Official title: Improving the Assessment and Treatment of Chronic Pain in Veterans With Serious Mental Illness
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Schizophrenia
Psychotic Disorders
Bipolar Disorder
Affective Disorders, Psychotic
Keywords: Veterans
chronic pain
psychotic disorders
affective disorders, psychotic
cognitive behavioral therapy
ecological momentary assessment
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Maryland Health Care System
First posted: 2019-10-08
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study involves a pilot randomized controlled trial (RCT) with 45 Veterans with co-occurring SMI and chronic musculoskeletal pain to examine feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) and preliminarily evaluate participant responses to intervention. The first 45 Veterans who pass screening will be enrolled and randomized to study condition on a rolling basis. Participants will be randomly assigned at a 2:1 ratio to CBT-CP:Health \& Wellness using permuted block randomization with randomly varying block sizes. Veterans will be randomly assigned to either CBT-CP (n = 30) or a manualized Health \& Wellness active control intervention (n = 15). Using an intent-to-treat framework, data will be collected from every participant during the one-week Ecological Momentary Assessment period (prior to RCT baseline assessment) and at baseline, post-treatment, and 3-month follow-up regardless of attendance in their assigned condition.
Primary purpose: TREATMENT

Brief summary: Chronic pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic pain leads to poorer mental health and physical functioning, and represents a critical obstacle to rehabilitation and recovery. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to: a) evaluate nonpharmacological pain management strategies in this population, and b) examine directional relations between chronic pain and SMI symptoms. This study aims to address research and clinical gaps by: a) testing the feasibility and acceptability of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI, and b) better assessing the complex relation between chronic pain and psychiatric symptoms and their impact on functioning. Results from this study will inform us as to whether CBT-CP is feasible to implement, acceptable to Veterans with SMI, and worth examining in its standard or in an optimized form in a larger clinical trial.

Detailed description: This research study will address critical gaps in our understanding and management of chronic musculoskeletal pain in Veterans with serious mental illness (SMI), addressing the following aims:

Aim 1: Complete a pilot randomized controlled trial (RCT) with 45 Veterans with co-occurring SMI and chronic musculoskeletal pain to examine feasibility and acceptability of CBT-CP and preliminarily evaluate participant responses to intervention.

Aim 1a (Primary): Determine feasibility by demonstrating adequate rates of recruitment and completion of and fidelity to the CBT-CP intervention as well as quality and acceptability of chosen assessments.

Aim 1b (Primary): Determine acceptability by obtaining favorable ratings from satisfaction questionnaires and interviews.

Aim 1c (Exploratory): Preliminarily evaluate participant responses to intervention by exploring changes in functioning and quality of life among Veterans randomized to the CBT-CP condition (n=30).

Aim 2: Determine the feasibility of collecting EMA data to examine the temporal relationships among mental health symptoms, pain severity, and health-related functioning. Data will be collected at baseline from the 45 Veterans in the Aim 1 RCT.

Aim 2b (Primary): Determine feasibility of this approach through adherence to the EMA call schedule and overall response rates.

Aim 2a (Exploratory): Explore relationships among mental health symptoms, pain severity, and health-related functioning captured in real time.

Aim 3: Complete a well-specified process evaluation to explore how to optimize CBT-CP for use in Veterans with SMI and chronic musculoskeletal pain in future clinical trials. This evaluation will integrate qualitative data from 15 interviews with Veterans in the CBT-CP condition, CBT-CP interventionist notes, and quantitative data from Aims 1 and 2.

Eligibility criteria: Inclusion Criteria:

* Have a chronic musculoskeletal pain diagnosis
* Have a Defense and Veterans Pain Rating Scale (DVPRS) rating of 4 or greater for pain severity
* Meet criteria for an SMI diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder) per medical record
* 18 years of age or older
* Enrolled in outpatient programming within the VA Maryland Health Care System at time of consent/study reenrollment
* Have regular access to a telephone
* Capacity to sign informed consent

Exclusion Criteria:

* Are engaging in moderate-to-severe substance use that would impact their ability to participate and/or would require a higher level of care (as determined by treating provider)
* Engagement in Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), whether currently or in the past
* Have a current acute pain condition or limited mobility (i.e., unable to walk one city block) that would interfere with their ability to engage in CBT-CP interventions (e.g., activity pacing/walking program)

Primary outcomes:
measure: Participant Satisfaction Questionnaire (CSQ-8)
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
measure: Service Satisfaction Scale (SSS-30)
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
measure: Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) Feasibility
timeFrame: Data will be gathered from each participant through intervention completion, an average of 10 weeks
Secondary outcomes:
measure: West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Interference
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
measure: Veterans RAND 36-item Health Survey (VR-36)
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
measure: World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks
measure: West Haven-Yale Multidimensional Pain Inventory (WHYMPI) - Interference
timeFrame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
measure: Veterans RAND 36-item Health Survey (VR-36)
timeFrame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
measure: World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
measure: World Health Organization Quality of Life Scale (WHOQOL-BREF)
timeFrame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Letitia Travaglini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Birgenheir DG, Ilgen MA, Bohnert AS, Abraham KM, Bowersox NW, Austin K, Kilbourne AM. Pain conditions among veterans with schizophrenia or bipolar disorder. Gen Hosp Psychiatry. 2013 Sep-Oct;35(5):480-4. doi: 10.1016/j.genhosppsych.2013.03.019. Epub 2013 Apr 29.
citation: Stewart MO, Karlin BE, Murphy JL, Raffa SD, Miller SA, McKellar J, Kerns RD. National dissemination of cognitive-behavioral therapy for chronic pain in veterans: therapist and patient-level outcomes. Clin J Pain. 2015 Aug;31(8):722-9. doi: 10.1097/AJP.0000000000000151.