Mindfulness for Pain and Suicide

NCT ID: NCT05286112

Last Updated: 2024-08-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

76 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-06

Study Completion Date

2025-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Pain Suicidal Ideation Suicide, Attempted Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Mindfulness-Based Cognitive Therapy (MBCT)

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

Group Type EXPERIMENTAL

Mindfulness-Based Cognitive Therapy (MBCT)

Intervention Type BEHAVIORAL

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

Health Education

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

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Health Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

Canandaigua VA Medical Center

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Veterans Affairs Center of Excellence for Suicide Prevention

Canandaigua, New York, United States

Site Status

Countries

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United States

Other Identifiers

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1600604

Identifier Type: -

Identifier Source: org_study_id

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