Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Affective Disorders, Psychotic
  • Bipolar Disorder
  • Chronic Pain
  • Psychotic Disorders
  • Schizophrenia
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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.Masking: Single (Outcomes Assessor)Masking Description: Data will be collected by experienced Research Assistants (Ras) who will receive in-person training on each assessment measure. All RAs involved in the research study will conduct baseline assessments. One RA will remain blind to study condition in order to complete post-treatment and follow-up assessments. A back-up RA supplied by the VISN 5 MIRECC will be trained to conduct assessments in case the blind assessor is unblinded or in need of assistance. If the study condition becomes known, the blind assessor will stop the assessment and either the back-up RA or study PI will finish the assessment(s).Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 chroni...

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.

Tracking Information

NCT #
NCT04118283
Collaborators
VA Maryland Health Care System
Investigators
Principal Investigator: Letitia Travaglini, PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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