Suicide Prevention for Patients With Chronic Pain

NCT ID: NCT04490265

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-05-20
• Study Completion Date: 2023-12-27

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.

Conditions

Suicide; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Problem-Solving Treatment

Our PST is 12-weeks and teaches patients strategies to address real-life problems.20 Sessions are once a week for one hour except for the first session, which is two hours. The treatment has four main goals: 1. Safety planning; 2. Problem-orientation-addressing how patients approach problems; 3. Planful problem-solving or a logical approach to address problems; 4. Behavioral activation of daily activities. Patients are provided weekly worksheets on problem-solving and receive weekly assessment of emotional state and suicidal ideation monitoring.

Group Type: EXPERIMENTAL

Problem-solving treatment

Intervention Type: BEHAVIORAL

included in arm descriptions

Supportive Psychotherapy

Our control will be supportive psychotherapy which will focus on discussing weekly stressors in a supportive, non-directive way. Session content is patient-driven, and sessions focus on emphasizing the patients' strengths, following patients' emotional affect, and building a therapeutic alliance. Participants will be asked to generate the topic they would like to discuss for the session and will complete a worksheet between sessions noting emotional events throughout their week ("A time when I felt stressed was …" ) in order to help identify experiences for discussion in session. Participants will be informed that the control condition is supportive and non-directive, and that providers will not engage in problem-solving. Providers will be taught to use reflective listening, clarification, empathy, and validation. The control consists of 12 weekly sessions delivered via telephone or video.

Group Type: PLACEBO_COMPARATOR

Supportive Psychotherapy

Intervention Type: BEHAVIORAL

included in arm descriptions

Interventions

Problem-solving treatment

included in arm descriptions

Intervention Type: BEHAVIORAL

Supportive Psychotherapy

included in arm descriptions

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Rutgers University

OTHER

Sponsor Role: collaborator

Veterans BioMedical Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lisa M McAndrew, PhD

Role: PRINCIPAL_INVESTIGATOR

VA NJHCS

Locations

VA NJHCS

East Orange, New Jersey, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R56MH121555

Identifier Type: NIH

Identifier Source: org_study_id

View Link