Clinical trial NCT04490265: Suicide Prevention for Patients With Chronic Pain
Official title: Suicide Prevention for Patients With Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide
Chronic Pain
Lead sponsor: Veterans BioMedical Research Institute
Sponsor class: OTHER
Collaborators: name: Rutgers University
First posted: 2020-07-29
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with chronic pain and moderate suicide risk (n=60) will be randomized to receive remote-PST or remote-supportive psychotherapy. We will assess problem-solving deficits through self-report, objective neuropsychological assessment and caregiver report. We have used an adaptive design so that if there is strong evidence for target engagement, we will continue with the trial as a fully powered clinical trial (i.e., the end of the current proposal will act as the interim assessment) to the determine the efficacy of remote PST for patients with chronic pain and moderate suicide risk (n=190) to improve suicide outcomes.

Detailed description: Every day, 120 people die from suicide, that is one person every 15 minutes.1 Suicide prevention treatments focus on those at highest risk and are primarily delivered as mental health treatments,2-5 and yet 70% of patients with suicide risk do not attend mental health treatment. Developing treatment for patients not served by existing suicide prevention programs will improve access to care and is necessary to stop suicide.

Patients with chronic pain in the US (100 million) have 2.6-times greater risk of suicide and those on long-term opioid treatment are at even greater risk. Unfortunately, they often do not receive mental health treatment and thus do not receive suicide prevention interventions. They do receive frequent healthcare for their pain providing an unmet opportunity to integrate suicide prevention into their treatment for pain.

Problem-solving treatment (PST) is an evidence-based approach that is available where patients want to receive treatment (e.g., primary care) and is efficacious for chronic pain. Importantly, PST targets problem-solving deficits which are known to increase risk of suicide, suggesting PST could be leveraged to reduce suicide risk. Deficits in problem-solving (an executive function of finding solutions to difficult issues) directly increase suicidal risk because they keep patients with active suicidal ideation from generating solutions to their problems (e.g., chronic pain), other than through suicide. Deficits in problem-solving also make it difficult to keep pain from impairing daily activities and social relationships. This indirectly increases suicide risk because impairment in daily activities increases feelings of burdensomeness and impairment in social relationships increases feelings of not belonging. Feelings of burdensomeness and of not belonging are key theoretical pathways to suicidal behavior.

Working with our clinical partners and patients, we developed a 12-week remote delivered PST for patients with chronic pain and moderate suicidal risk. The treatment addresses deficits in problem-solving by teaching patients strategies to address problems caused by chronic pain that increase risk of suicide (e.g., impairment in daily activities leading to feelings of burdensomeness). Our preliminary data suggests that PST is feasible, acceptable and may be efficacious. In a national survey we found 56% of patients with chronic pain and suicide risk were interested in problem-solving treatment. In a clinical pilot we were able to engage Veterans with chronic pain and suicide risk with 75% completing the treatment. Finally, in a clinical trial that randomized patients to 12 sessions of PST or 12 sessions of health education, we found that patients with chronic pain and moderate suicide risk (n=21) randomized to PST had a reduction in suicidal ideation and problem-solving deficits (self-report) as compared to health education.

The goal of the current proposal (R56) is to ensure PST is engaging problem-solving deficits. Patients with chronic pain and moderate suicide risk (n=60) will be randomized to receive remote-PST or remote-supportive psychotherapy. We will assess problem-solving deficits through self-report, objective neuropsychological assessment and caregiver report. We have used an adaptive design so that if there is strong evidence for target engagement, we will continue with the trial as a fully powered clinical trial (i.e., the end of the current proposal will act as the interim assessment) to the determine the efficacy of remote PST for patients with chronic pain and moderate suicide risk (n=190) to improve suicide outcomes.

Aim 1: Estimate the effect of remote-delivered PST on targets. We hypothesize that PST reduces our primary target, problem-solving deficits as assessed through (H1) self-report, (H2) objective neuropsychological assessment, (H3) caregiver report, as compared to supportive psychotherapy. We hypothesize that PST reduces our secondary targets (H1) feelings of burdensomeness and (H2) feelings of not belonging, as compared to supportive psychotherapy.

Exploratory Aim 2: Explore the effect size of PST as compared to supportive psychotherapy on suicide outcomes (intensity of suicidal ideation, difficulties coping with suicidal ideation) and chronic pain outcomes ((H4) chronic pain, (H5) pain related disability).

Our previous preliminary data suggests that PST is feasible, acceptable and may be efficacious. The goal of the current proposal (R56) is to confirm PST is engaging problem-solving deficits (measured through self-report and objective measures). Deliverable: At the end of the proposed trial, we will have the necessary information (in combination with our previous preliminary data) to inform a go/no-go decision on converting the current proposal into a fully powered clinical trial.

Eligibility criteria: Inclusion criteria will include:

* has a VA primary care provider and has had an in-person visit with a VA provider in the past year;
* pain that is (b1) musculoskeletal, defined as regional (joints, limbs, back, neck) or more generalized (chronic widespread pain);
* pain that is (b2) moderately severe, defined as a Brief Pain Inventory (BPI) intensity item score of 5 or higher for either "average" or "worst" pain in the past week;
* pain that is (b3) persistent, (i.e., ≥3 months)
* active suicidal ideation defined as scoring a 2 to 4 on the C-SSRS.

Exclusion Criteria:

* life-threatening condition
* severe cognitive impairment
* psychotic disorder
* pregnant or plans to become pregnant in the next year
* suicide attempt in the past year or hospitalization for suicide risk in the past year

Primary outcomes:
measure: Social problem-solving inventory - patient report
timeFrame: Change from Baseline to 12 weeks
measure: Social problem-solving inventory - patient report
timeFrame: Change from Baseline to 6 months
measure: Social problem-solving inventory - caregiver report
timeFrame: Change from Baseline to 12 weeks
measure: Social problem-solving inventory - caregiver report
timeFrame: Change from Baseline to 6 months
measure: Emotional Go No Go
timeFrame: Change from Baseline to 12 weeks
measure: Means End Problem-Solving Task
timeFrame: Change from Baseline to 12 weeks
measure: Iowa Gambling Task
timeFrame: Change from Baseline to 12-weeks
measure: Emotional Stroop
timeFrame: Change from Baseline to 12 weeks
Secondary outcomes:
measure: Interpersonal Needs Questionnaire
timeFrame: Change from Baseline to 12 weeks.. The belonging subscale is 6 items and scores range from 0-42 with higher scores indicating less belonging, the burdensomeness subscale is 9 items with higher scores indicating greater burdensomeness.
Other outcomes:
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Change from Baseline to 12 weeks
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: Change from Baseline to 6 months
measure: Suicide Ideation Questionnaire (SIQ).
timeFrame: Change from Baseline to 12 weeks
measure: Suicide Ideation Questionnaire (SIQ).
timeFrame: Change from Baseline to 6 months
measure: Suicide-Related Coping Scale
timeFrame: Change from Baseline to 12 weeks
measure: Suicide-Related Coping Scale
timeFrame: Change from Baseline to 6 months
measure: Pain Disability Index (PDI)
timeFrame: Change from Baseline to 12 weeks
measure: Pain Disability Index (PDI)
timeFrame: Change from Baseline to 6 months
measure: Brief Pain Inventory (BPI)
timeFrame: Change from Baseline to 12 weeks
measure: Brief Pain Inventory (BPI)
timeFrame: Change from Baseline to 6 months
Locations:
city: East Orange
country: United States
facility: VA NJHCS
state: New Jersey
Study officials:
affiliation: VA NJHCS
name: Lisa M McAndrew, PhD
role: PRINCIPAL_INVESTIGATOR
References: