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Completed

NCT Number: NCT05286112

Mindfulness for Pain and Suicide

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Veterans Affairs Center of Excellence for Suicide Prevention

Canandaigua, New York, 14424, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Health Education

Behavioral

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

Primary outcomes

  1. Treatment acceptability

    Time frame: 1-month post-treatment

    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.

  2. Suicide risk

    Time frame: baseline to 6 months post-treatment follow-up

    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.

  3. Depression

    Time frame: baseline to 6 months post-treatment follow-up

    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.

  4. Interpersonal Needs

    Time frame: baseline to 6 months post-treatment follow-up

    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.

  5. Pain Interference and intensity

    Time frame: baseline to 6 months post-treatment follow-up

    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.

Secondary outcomes

  1. Health-related Quality of Life

    Time frame: baseline to 6 months post-treatment follow-up

    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.

  2. Mindfulness

    Time frame: baseline to 6 months post-treatment follow-up

    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.

  3. Pain acceptance

    Time frame: baseline to 6 months post-treatment follow-up

    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.

  4. Pain catastrophizing

    Time frame: baseline to 6 months post-treatment follow-up

    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.

  5. Pain-related self-efficacy

    Time frame: baseline to 6 months post-treatment follow-up

    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.

  6. Fear of pain

    Time frame: baseline to 6 months post-treatment follow-up

    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.

Sponsors and collaborators

Lead sponsor

Canandaigua VA Medical Center

Fed

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

A Pilot Study on Mindfulness for Pain and Mental Health Outcomes

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Mar 18, 2022
Registry last updated
Jun 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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