CBT-CP for Veterans With SMI

Official title

Exploring the Efficacy of Cognitive Behavioral Therapy for Chronic Pain in Veterans With Serious Mental Illness

Overview

Chronic musculoskeletal pain has a highly negative impact on Veterans, especially those with serious mental illness (SMI). Chronic musculoskeletal pain leads to poorer mental and physical health-related functioning, representing a critical obstacle to rehabilitation and recovery for SMI Veterans. Despite known high prevalence rates of chronic pain in SMI populations, there is little research to evaluate nonpharmacological pain management strategies in this population. This study aims to address this research and clinical gap by testing the efficacy of Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) - a VA evidence-based psychotherapy for chronic pain - in Veterans with SMI and chronic low back pain. The study will primarily evaluate the impact of CBT-CP on pain-related functioning, quality of life, and pain severity. This study will also examine relationships between pain and mental health symptoms, and how these relationships may change with CBT-CP completion.

Detailed description

Project Background: Chronic musculoskeletal pain is one of the most common physical health diagnoses among individuals with SMI. Individuals with SMI and chronic musculoskeletal pain report worse mental and physical health functioning relative to people with other mental or physical health conditions. Despite knowing about high rates of chronic musculoskeletal pain among individuals with SMI; little research has been conducted to further understand the complex relation between pain and psychiatric symptoms and consider the usefulness or appropriateness of current treatment approaches. What is known is problematic: Veterans with SMI are largely not provided options for nonpharmacological pain management strategies, including CBT-CP, and are more likely to be prescribed pain medications that pose unique risks to this population.

Project Objectives: The proposed Merit research will address research and clinical gaps by testing the efficacy of CBT-CP in Veterans with SMI and chronic musculoskeletal pain, notably chronic low back pain. The investigators will complete a large, randomized controlled trial with 190 Veterans, comparing CBT-CP to an active control condition ("Health \& Wellness"). The investigators will examine effects of treatment on functioning and pain interference, quality of life, and pain severity. The investigators will evaluate these variables at baseline, post-treatment, and six months post-treatment through both standardized assessment procedures and timepoints; as well as a one-week ecological momentary assessment (EMA) period prior to each assessment timepoint. The EMA data will allow us to examine inter- and intra-variability in pain and related functioning, including its relationship to SMI symptoms, and to evaluate how engagement in CBT-CP may affect pain variability and its relationship to mental health.

Project Methods: This project will include completing a randomized control trial (RCT) with 190 Veteran participants, evaluating impact of CBT-CP versus Health \& Wellness on pain-related functioning and interference, quality of life, and pain severity. The investigators will also explore process variables, including physical activity and pain catastrophizing, as well as moderators, including SMI diagnosis and symptom severity along with pain severity at baseline, to see how these variables affect treatment engagement and outcomes.

Interventions

• Behavioral Cognitive Behavioral Therapy for Chronic Pain (CBT-CP)
  Cognitive Behavioral Therapy for Chronic Pain (CBT-CP) will be conducted in accordance with the Cognitive Behavioral Therapy for Chronic Pain: Therapist Manual and the VA Evidence-Based Practice (EBP) roll-out training. CBT-CP consists of a 12-session protocol, including an initial assessment session (BL assessment; Session 1), 10 content-specific sessions (pain education, goal-setting, cognitive and behavioral skill building; Sessions 2-11), and a booster session scheduled approximately one mon
• Behavioral Health & Wellness (H&W)
  Health \& Wellness (H\&W) was developed by VISN 5 MIRECC investigators and consists of psychoeducation on topics related to physical and emotional wellbeing. Its structure is similar to CBT-CP (10 weekly individual 60-minute sessions, no booster session). Each Health \& Wellness session will be led by a trained interventionist using a manualized curriculum that includes review of previous session material, introduction of new information, and discussion of a range of health-related topics (physi

Primary outcome measures

• Brief Pain Inventory-Interference (BPI-INT) [Time frame: post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)]
• Veterans RAND 36-Item Health Survey (VR-36) [Time frame: post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)]
• PEG-3 [Time frame: post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)]

Secondary outcome measures (2)

• Pain Numeric Rating Scale (PNRS) [Time frame: post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)]
• PEG-3 [Time frame: post-treatment (~4 months after randomization); 6-month follow-up (~10 months after randomization)]

Eligibility criteria

Inclusion criteria

• Have chronic back pain, per medical record
• Have a PEG-3 rating of 4 or greater for pain severity or interference
• Meet criteria for an SMI diagnosis (schizophrenia, schizoaffective disorder, bipolar disorder, major depression with psychosis) per medical record
• 18 years of age or older
• Enrolled in outpatient programming within a VISN 5 health care facility at time of consent
• 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 individual Cognitive Behavioral Therapy for Chronic Pain (CBT-CP), whether currently or in the past 12 months
• Have a current acute pain condition, medical 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

United States · 1 center

• Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD — Baltimore

Publications

• Travaglini LE, Bennett M, Kacmarek CN, Kuykendall L, Coakley G, Lucksted A. Barriers to accessing pain management services among veterans with bipolar disorder. Health Serv Res. 2023 Dec;58(6):1224-1232. doi: 10.1111/1475-6773.14221. Epub 2023 Sep 4. PMID 37667502
• Travaglini LE, Kuykendall L, Bennett ME, Abel EA, Lucksted A. Relationships between chronic pain and mood symptoms among veterans with bipolar disorder. J Affect Disord. 2020 Dec 1;277:765-771. doi: 10.1016/j.jad.2020.08.069. Epub 2020 Sep 1. PMID 33065815

Identifiers

NCT: NCT06758414 · D5049-R · 1 I01 RX005049-01A2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗