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. Data are from the 1-month follow-up assessment.	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.	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.	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.	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.	baseline to 6 months post-treatment follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	6-months post treatment assessment

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mindfulness	We used the Five Facet Mindfulness Questionnaire (FFMQ) to assess mindfulness. Scores range from 39 to 195 with higher scores indicating higher mindfulness. Data are from the 6-month follow-up assessment.	6 months post-treatment follow-up
Pain Acceptance	Pain acceptance was assessed using the Chronic Pain Acceptance Questionnaire (CPAQ) scores range from 0 to 120 with higher scores indicating greater acceptance of pain with higher scores indicating greater pain acceptance.	6 months post-treatment follow-up
Pain Catastrophizing	Pain catastrophizing was assessed using the Pain Catastrophizing Scale (PCS). Scores range from 0 to 52 with higher scores indicate greater pain catastrophizing. Data are from the 6-month follow-up assessment.	baseline to 6 months post-treatment follow-up
Fear of Movement	Fear of movement due to pain will be measured using the Tampa Scale of Kinesiophobia. The scores range from 17-68 with higher scores indicating indicating greater fear of movement. Data are from the 6-month follow-up assessment.	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): August 25, 2026
• Last Update Submitted That Met QC Criteria: August 3, 2026
• Last Verified: August 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