Chronic Pain, Opioid Use, Suicidal Ideation, Suicide, Attempted
Conditions
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.
Interventions
BEHAVIORALMindfulness-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.
BEHAVIORALHealth Education
Health education provides information on the importance and benefits of and guidelines for living a healthy lifestyle.
Sponsors
Canandaigua VA Medical Center
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Acceptability | 1-month post-treatment | 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. Data are from the 1-month follow-up assessment. |
| Suicidal Ideation Intensity | 6-month post treatment follow-up | Suicide ideation intensity will be assessed using the Columbia Suicide Severity Rating Scale Ideation intensity subscale. Scores range from 2 to 25 with higher scores indicating greater intensity of ideation. Data are from the 6-month follow-up assessment. |
| Depression | 6 months post-treatment follow-up | The Patient Health Questionnaire-9 was used to assess depression symptoms. Scores range from 0 to 27 with higher scores indicating greater severity of depression. Data are from the 6-month follow-up assessment. |
| Interpersonal Needs | 6-months post-treatment follow-up | The Interpersonal Needs Questionnaire was used to assessed interpersonal needs. Scores range from 12 to 84 with higher scores indicating greater conflict with interpersonal needs. Data are from the 6-month follow-up assessment. |
| Pain Interference | baseline to 6 months post-treatment follow-up | Pain interference was measured using the Brief Pain Inventory. Scores range from 0 to 10 with higher scores indicating greater pain-related interference in activities. Data are from the 6-month follow-up assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Health-related Quality of Life | 6 months post-treatment follow-up | The Veterans Rand (VR)-12 was used to assess physical health-related quality of life. Scores fall between 20 and 60 in clinical populations with higher scores indicating higher physical health-related quality of life. Data are from the 6-month follow-up assessment. |
| Pain Intensity | baseline to 6 months post-treatment follow-up | Pain intensity was assessed using the Brief Pain Inventory Pain Severity subscale. Scores range from 0 to 10 with higher scores indicating more severe pain intensity. Data are from the 6-month follow-up assessment. |
| Mental Health-related Quality of Life | 6-months post treatment assessment | The Veterans Rand (VR)-12 was used to assess mental health-related quality of life. Scores fall between 20 and 60 in clinical populations with higher scores indicating higher mental health-related quality of life. Data are from the 6-month follow-up assessment. |
Countries
United States
Participant flow
Recruitment details
Potential participants were recruited through a case finding procedure of VHA medical records.
Pre-assignment details
Potential participants were screened for eligibility, consented (if eligible and interested), and completed a baseline assessment.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 53.3 years STANDARD_DEVIATION 14.4 |
| Depression | 20.1 scores on a scale STANDARD_DEVIATION 7.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Fear of movement | 44.8 Scores on a scale STANDARD_DEVIATION 6.7 |
| Interpersonal needs | 41.6 scores on a scale STANDARD_DEVIATION 14.9 |
| Mental health-related quality of life | 28.9 scores on a scale STANDARD_DEVIATION 10.8 |
| Mindfulness | 116.0 scores on a scale STANDARD_DEVIATION 14.9 |
| Pain acceptance | 21.4 Scores on a scale STANDARD_DEVIATION 10.5 |
| Pain catastrophizing | 32.0 Scores on a scale STANDARD_DEVIATION 10.4 |
| Pain intensity | 5.8 scores on a scale STANDARD_DEVIATION 1.3 |
| Pain interference | 7.1 scores on a scale STANDARD_DEVIATION 1.8 |
| Physical health-related quality of life | 26.7 scores on a scale STANDARD_DEVIATION 10.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Sex: Female, Male Female | 30 Participants |
| Sex: Female, Male Male | 46 Participants |
| Suicidal ideation intensity | 1.91 score on a scale STANDARD_DEVIATION 1.25 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 38 |
| other Total, other adverse events | 13 / 38 | 19 / 38 |
| serious Total, serious adverse events | 7 / 38 | 6 / 38 |
Outcome results
None listed