Mindfulness for Pain and Suicide

NCT05286112 | Completed DMC

• 1 other identifier: 1600604
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Pain; Suicidal Ideation; Suicide, Attempted; Opioid Use

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Health-related Quality of Life

  baseline to 6 months post-treatment follow-up

• Mindfulness

  baseline to 6 months post-treatment follow-up

• Pain acceptance

  baseline to 6 months post-treatment follow-up

• Pain catastrophizing

  baseline to 6 months post-treatment follow-up

• Pain-related self-efficacy

  baseline to 6 months post-treatment follow-up

Study Arms (2)

Mindfulness-Based Cognitive Therapy (MBCT)

EXPERIMENTAL

MBCT delivered over the course of 10, \~60 minute sessions

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Health Education

ACTIVE COMPARATOR

Health education sessions delivered over the course of 10, \~60 minute sessions

Behavioral: Health Education

Interventions

Mindfulness-Based Cognitive Therapy (MBCT) BEHAVIORAL

10 sessions focused on increasing mindfulness awareness to address thoughts, emotions, and behaviors that maintain functional impairment and risk of suicide.

Mindfulness-Based Cognitive Therapy (MBCT)

Health Education BEHAVIORAL

Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.

Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Canandaigua VA Medical Center: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

Department of Veterans Affairs Center of Excellence for Suicide Prevention

Canandaigua, New York, 14424, United States

Location

MeSH Terms

Conditions

Chronic Pain; Suicidal Ideation; Suicide, Attempted

Interventions

Mindfulness-Based Cognitive Therapy

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: March 18, 2022
• Study Start: March 6, 2023
• Primary Completion: March 21, 2025
• Study Completion: March 21, 2025
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

US (1)