Mindfulness for Pain and Suicide

Canandaigua VA Medical Center

Status: Active, not recruiting

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

Treatments: Behavioral: Mindfulness-Based Cognitive Therapy (MBCT); Behavioral: Health Education

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT05286112

1600604

Details and patient eligibility

About

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.

Full 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.

Enrollment: 76 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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76 participants in 2 patient groups

Mindfulness-Based Cognitive Therapy (MBCT)

Experimental group

Description:

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

Treatment:

Behavioral: Mindfulness-Based Cognitive Therapy (MBCT)

Health Education

Active Comparator group

Description:

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

Treatment:

Behavioral: Health Education