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.
Time frame: 1-month post-treatment
Suicide risk
Suicide risk will be assessed using the Columbia Suicide Severity Rating Scale, which assesses presence and severity of suicidal ideation and behaviors in one's lifetime, over a specified period, and since the last visit. Presence of suicidal thoughts and behaviors are scored as either present (0) or absent (1) and severity is indicated as the most severe suicidal thought or behavior endorsed (from 0-none to 5-suicide attempt). Higher scores indicate more severe suicidal ideation and behaviors.
Time frame: baseline to 6 months post-treatment follow-up
Depression
The Patient Health Questionnaire-9, a 9-item measure assessing frequency of depression symptoms in the last week. Rating scale is from 0 to 3 with higher scores indicating more frequent depression symptoms.
Time frame: baseline to 6 months post-treatment follow-up
Interpersonal Needs
The Interpersonal Needs Questionnaire is a 12-item questionnaire measuring level of belonging and feeling like a burden to others. Items are rating on a scale ranging from 1 to 7 with higher scores indicate greater interpersonal conflict.
Time frame: baseline to 6 months post-treatment follow-up
Pain Interference and intensity
Pain interference and intensity will be measured using the Brief Pain Inventory. Four items assessing current, average, worst, and least pain experienced. Pain interference is assessed over 7 items across various life domains. Items are rated from 0 to 10 with higher scores indicating more severe pain intensity and greater interference in activities due to pain.
Time frame: baseline to 6 months post-treatment follow-up
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Health-related Quality of Life
The Veterans Rand (VR)-12 is a 12-item measure assessing health-related quality of life across physical (PCS) and mental health (MCS) components. PCS and MCS scores are derived using an algorithm that is referenced to a metric centered at 50.0. VR-12 scores are standardized using a T-score metric with a mean of 50 and a standard deviation of 10 with higher scores indicating better health-related quality of life.
Time frame: baseline to 6 months post-treatment follow-up
Mindfulness
The Five Facet Mindfulness Questionnaire (FFMQ) consists of 39 items that assess five elements of mindfulness: observing, describing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. The rating scale ranges from 1 to 5 with higher scores indicated higher mindfulness.
Time frame: baseline to 6 months post-treatment follow-up
Pain acceptance
The Chronic Pain Acceptance Questionnaire (CPAQ) is a 20-item measure that assesses two components of pain acceptance: pursuit of life activities regardless of pain and recognition that avoidance is not useful in adapting to chronic pain. The rating scale ranges from 0 to 6 with higher scores indicating greater pain acceptance.
Time frame: baseline to 6 months post-treatment follow-up
Pain catastrophizing
The Pain Catastrophizing Scale (PCS) is a 13-item measure, with each item rated on a 5-point rating scale (0 = "Not at all" to 4 = "All the time"). The measure is divided into three subscales: magnification, rumination, and helplessness. Higher scores indicate greater pain catastrophizing.
Time frame: baseline to 6 months post-treatment follow-up
Pain-related self-efficacy
The Pain Self-efficacy Questionnaire (PSEQ) assesses one's confidence in performing activities while in pain. The rating scale ranges from 0 to 6 with higher scores indicating greater self-efficacy.
Time frame: baseline to 6 months post-treatment follow-up
Fear of pain
The Tampa Scale of Kinesiophobia-11 (TSK) is an 11-item measure assessing pain-related fear of movement or injury. The rating scale ranges from 1 to 4 with high scores indicating greater fear of movement.
Time frame: baseline to 6 months post-treatment follow-up