Mindfulness for Pain and Suicide

A Pilot Study on Mindfulness for Pain and Mental Health Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Suicidal Ideation; Suicide, Attempted; Opioid Use
• Intervention / Treatment: Behavioral: Health Education; Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Detailed Description

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
• Enrollment (Actual): 76
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • Canandaigua, New York, United States, 14424
      • Department of Veterans Affairs Center of Excellence for Suicide Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• English-speaking veterans
• Ages 18 years and older
• Understand informed consent
• Report pain that occurs on at least half the days for six months or more
• Score at least a 4 on each item of the three items on a brief pain intensity and interference measure
• To meet the minimum threshold for suicide risk, veterans must meet at least one of the following: (1) endorse at least a 1 ("several days") on item 9 ("thoughts of you would be better off dead, or thoughts of hurting yourself in some way" in the past 2 weeks) of the Patient Health Questionnaire-9 (PHQ-9), (2) endorse at least "death ideation" in the last 3 months as measured by the Columbia Suicide Severity Rating Scale, or (3) report a suicide attempt in the last 6 months.

Exclusion Criteria:

• An active severe substance use disorder (SUD)
• Documented schizophrenia, active psychosis, or mania
• Upcoming surgeries
• Uncontrolled medical conditions
• Intent to carry out a plan for suicide.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness-Based Cognitive Therapy (MBCT); MBCT delivered over the course of 10, ~60 minute sessions	Behavioral: Mindfulness-Based Cognitive Therapy (MBCT); 10 sessions focused on increasing mindfulness awareness to address thoughts, emotions, and behaviors that maintain functional impairment and risk of suicide.
Active Comparator: Health Education; Health education sessions delivered over the course of 10, ~60 minute sessions	Behavioral: Health Education; Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	baseline to 6 months post-treatment follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	baseline to 6 months post-treatment follow-up

Collaborators and Investigators

• Sponsor: Canandaigua VA Medical Center
• Collaborators: National Center for Complementary and Integrative Health (NCCIH)

Study record dates

Study Major Dates

• Study Start (Actual): March 6, 2023
• Primary Completion (Actual): February 28, 2026
• Study Completion (Actual): February 28, 2026

Study Registration Dates

• First Submitted: January 28, 2022
• First Submitted That Met QC Criteria: March 17, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2026
• Last Update Submitted That Met QC Criteria: June 11, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Behavioral Symptoms; Self-Injurious Behavior; Suicide; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Suicidal Ideation; Chronic Pain; Suicide, Attempted; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Cognitive Behavioral Therapy; Mindfulness; Mindfulness-Based Cognitive Therapy
• Other Study ID Numbers: 1600604

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Participant data is available upon request as part of scientific collaboration.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No