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Mindfulness for Pain and Suicide

Primary Purpose

Chronic Pain, Suicidal Ideation, Suicide, Attempted

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness-Based Cognitive Therapy (MBCT)
Health Education
Sponsored by
Canandaigua VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Department of Veterans Affairs Center of Excellence for Suicide PreventionRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Cognitive Therapy (MBCT)

Health Education

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.

Full Information

First Posted
January 28, 2022
Last Updated
July 21, 2023
Sponsor
Canandaigua VA Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05286112
Brief Title
Mindfulness for Pain and Suicide
Official Title
A Pilot Study on Mindfulness for Pain and Mental Health Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2023 (Actual)
Primary Completion Date
February 28, 2025 (Anticipated)
Study Completion Date
February 28, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Canandaigua VA Medical Center
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain, Suicidal Ideation, Suicide, Attempted, Opioid Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Cognitive Therapy (MBCT)
Arm Type
Experimental
Arm Description
MBCT delivered over the course of 10, ~60 minute sessions
Arm Title
Health Education
Arm Type
Active Comparator
Arm Description
Health education sessions delivered over the course of 10, ~60 minute sessions
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Cognitive Therapy (MBCT)
Intervention Description
8 sessions focused on increasing mindfulness awareness to address thoughts, emotions, and behaviors that maintain functional impairment and risk of suicide.
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
Primary Outcome Measure Information:
Title
Treatment acceptability
Description
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.
Time Frame
1-month post-treatment
Title
Suicide risk
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Title
Depression
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Title
Interpersonal Needs
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Title
Pain Interference and intensity
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Secondary Outcome Measure Information:
Title
Health-related Quality of Life
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Title
Mindfulness
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Title
Pain acceptance
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Title
Pain catastrophizing
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Title
Pain-related self-efficacy
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up
Title
Fear of pain
Description
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.
Time Frame
baseline to 6 months post-treatment follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lisham Ashrafioun, PhD
Phone
585-430-2026
Email
lisham.ashrafioun@va.gov
Facility Information:
Facility Name
Department of Veterans Affairs Center of Excellence for Suicide Prevention
City
Canandaigua
State/Province
New York
ZIP/Postal Code
14424
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisham Ashrafioun, PhD
Phone
585-430-2026
Email
lisham.ashrafioun@va.gov

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Participant data is available upon request as part of scientific collaboration.

Learn more about this trial

Mindfulness for Pain and Suicide

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