Clinical trial NCT05286112: Mindfulness for Pain and Suicide
Official title: A Pilot Study on Mindfulness for Pain and Mental Health Outcomes
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chronic Pain
Suicidal Ideation
Suicide, Attempted
Opioid Use
Lead sponsor: Canandaigua VA Medical Center
Sponsor class: FED
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2022-03-18
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Treatment acceptability
timeFrame: 1-month post-treatment
measure: Suicide risk
timeFrame: baseline to 6 months post-treatment follow-up
measure: Depression
timeFrame: baseline to 6 months post-treatment follow-up
measure: Interpersonal Needs
timeFrame: baseline to 6 months post-treatment follow-up
measure: Pain Interference and intensity
timeFrame: baseline to 6 months post-treatment follow-up
Secondary outcomes:
measure: Health-related Quality of Life
timeFrame: baseline to 6 months post-treatment follow-up
measure: Mindfulness
timeFrame: baseline to 6 months post-treatment follow-up
measure: Pain acceptance
timeFrame: baseline to 6 months post-treatment follow-up
measure: Pain catastrophizing
timeFrame: baseline to 6 months post-treatment follow-up
measure: Pain-related self-efficacy
timeFrame: baseline to 6 months post-treatment follow-up
measure: Fear of pain
timeFrame: baseline to 6 months post-treatment follow-up
Other outcomes:
Locations:
city: Canandaigua
country: United States
facility: Department of Veterans Affairs Center of Excellence for Suicide Prevention
state: New York
Study officials:
References: