Mindfulness for Pain and Suicide

Chronic Pain Clinical Trial

Official title:

A Pilot Study on Mindfulness for Pain and Mental Health Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286112
• Other study ID #: 1600604
• Status: Recruiting
• Phase: N/A
• Start date: March 6, 2023
• Est. completion date: February 28, 2025

Study information

• Verified date: February 2023
• Source: Canandaigua VA Medical Center
• Contact: Lisham Ashrafioun, PhD
• Phone: 585-430-2026
• Email: lisham.ashrafioun[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: February 28, 2025
• Est. primary completion date: February 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Opioid Use
• Suicidal Ideation
• Suicide
• Suicide, Attempted

Intervention

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

Locations

Country	Name	City	State
United States	Department of Veterans Affairs Center of Excellence for Suicide Prevention	Canandaigua	New York

Sponsors (2)

Lead Sponsor	Collaborator
Canandaigua VA Medical Center	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment acceptability	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.	1-month post-treatment
Primary	Suicide risk	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.	baseline to 6 months post-treatment follow-up
Primary	Depression	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.	baseline to 6 months post-treatment follow-up
Primary	Interpersonal Needs	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.	baseline to 6 months post-treatment follow-up
Primary	Pain Interference and intensity	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.	baseline to 6 months post-treatment follow-up
Secondary	Health-related Quality of Life	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.	baseline to 6 months post-treatment follow-up
Secondary	Mindfulness	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.	baseline to 6 months post-treatment follow-up
Secondary	Pain acceptance	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.	baseline to 6 months post-treatment follow-up
Secondary	Pain catastrophizing	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.	baseline to 6 months post-treatment follow-up
Secondary	Pain-related self-efficacy	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.	baseline to 6 months post-treatment follow-up
Secondary	Fear of pain	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.	baseline to 6 months post-treatment follow-up