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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

Conditions

Chronic Pain Behavior Behavioral Symptoms Neurologic Manifestations Opioid Use Pain Pathological Conditions, Signs and Symptoms Self-Injurious Behavior Signs and Symptoms Suicidal Ideation Suicide Suicide, Attempted

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. Data are from the 1-month follow-up assessment.

  2. Suicidal Ideation Intensity

    Time frame: 6-month post treatment follow-up

    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.

  3. Depression

    Time frame: 6 months post-treatment follow-up

    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.

  4. Interpersonal Needs

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

    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.

  5. Pain Interference

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

    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.

Secondary outcomes

  1. Physical Health-related Quality of Life

    Time frame: 6 months post-treatment follow-up

    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.

  2. Pain Intensity

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

    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.

  3. Mental Health-related Quality of Life

    Time frame: 6-months post treatment assessment

    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.

Other outcomes

  1. Mindfulness

    Time frame: 6 months post-treatment follow-up

    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.

  2. Pain Acceptance

    Time frame: 6 months post-treatment follow-up

    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.

  3. Pain Catastrophizing

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

    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.

  4. Fear of Movement

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

    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.

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
Aug 25, 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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