The proposed study will assess the feasibility and acceptability of a mindfulness-based intervention to reduce functional impairment from chronic pain and risk of suicide.
The investigators are seeking to develop a combined intervention, MBCT-S/P, to focus on both improving functioning and mitigating suicide risk in veterans with chronic pain. The investigators plan to test the new manual's feasibility and acceptability in a sample of veterans experiencing chronic pain and suicidal ideation. Participants will be randomized to either the MBCT-S/P condition (n=38) or the Education control condition (n=38) to assess additional aspects of study feasibility. The investigators also plan to assess a variety of clinical outcomes including suicidal ideation, pain interference in activities, and opioid use. Participants will complete questionnaires pre-treatment, and 1-, 3-, and 6-months post-treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
76
10 sessions focused on increasing mindfulness awareness to address thoughts, emotions, and behaviors that maintain functional impairment and risk of suicide.
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
Department of Veterans Affairs Center of Excellence for Suicide Prevention
Canandaigua, New York, United States
Treatment Acceptability
The Abbreviated Acceptability Rating Profile assesses the extent to which participants agree with 8 statements about the intervention. Scores range from 1 to 6 with higher scores indicating higher acceptability. Data are from the 1-month follow-up assessment.
Time frame: 1-month post-treatment
Suicidal Ideation Intensity
Suicide ideation intensity will be assessed using the Columbia Suicide Severity Rating Scale Ideation intensity subscale. Scores range from 2 to 25 with higher scores indicating greater intensity of ideation. Data are from the 6-month follow-up assessment.
Time frame: 6-month post treatment follow-up
Depression
The Patient Health Questionnaire-9 was used to assess depression symptoms. Scores range from 0 to 27 with higher scores indicating greater severity of depression. Data are from the 6-month follow-up assessment.
Time frame: 6 months post-treatment follow-up
Interpersonal Needs
The Interpersonal Needs Questionnaire was used to assessed interpersonal needs. Scores range from 12 to 84 with higher scores indicating greater conflict with interpersonal needs. Data are from the 6-month follow-up assessment.
Time frame: 6-months post-treatment follow-up
Pain Interference
Pain interference was measured using the Brief Pain Inventory. Scores range from 0 to 10 with higher scores indicating greater pain-related interference in activities. Data are from the 6-month follow-up assessment.
Time frame: baseline to 6 months post-treatment follow-up
Physical Health-related Quality of Life
The Veterans Rand (VR)-12 was used to assess physical health-related quality of life. Scores fall between 20 and 60 in clinical populations with higher scores indicating higher physical health-related quality of life. Data are from the 6-month follow-up assessment.
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Time frame: 6 months post-treatment follow-up
Pain Intensity
Pain intensity was assessed using the Brief Pain Inventory Pain Severity subscale. Scores range from 0 to 10 with higher scores indicating more severe pain intensity. Data are from the 6-month follow-up assessment.
Time frame: baseline to 6 months post-treatment follow-up
Mental Health-related Quality of Life
The Veterans Rand (VR)-12 was used to assess mental health-related quality of life. Scores fall between 20 and 60 in clinical populations with higher scores indicating higher mental health-related quality of life. Data are from the 6-month follow-up assessment.
Time frame: 6-months post treatment assessment