Suicide Prevention for Patients With Chronic Pain

July 2, 2025 updated by: Veterans BioMedical Research Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • VA NJHCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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.
Behavioral: Problem-solving treatment
included in arm descriptions
Placebo Comparator: 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.
Behavioral: Supportive Psychotherapy
included in arm descriptions

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Iowa Gambling Task
Time Frame: Change from Baseline to 12-weeks
The Iowa gambling task is a neuropsychological task of problem-solving. The participgoal of the task is to make money. Participants are presented four decks of cards and have to choose the best deck to make money. The Iowa gambling task has been shown to change after problem-solving therapy. Scores range from -100 to 100 with higher equaling better problem-solving.
Change from Baseline to 12-weeks
Social Problem-solving Inventory - Patient Report
Time Frame: Change from Baseline to 12 weeks
The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score. Scores range from 0-100 with higher scores equaling better problem-solving.
Change from Baseline to 12 weeks
Social Problem-solving Inventory - Patient Report
Time Frame: Change from Baseline to 6 months
The Social problem-solving inventory - patient report measures problem-solving that is sensitive to change. In clinical research, the Social problem-solving inventory - patient report has been successfully used to elicit meaningful self-appraisals. The questionnaire is 52 items long. We will use the total score.Scores range from 0-100 with higher scores equaling better problem-solving.
Change from Baseline to 6 months
Emotional Go No Go
Time Frame: Change from Baseline to 12 weeks
Emotional Go No Go measures attention and impulse inhibition. Inhibiting impulses is a key component of preventing impulsive behavior that can lead to suicide. Reported is the hit rate with scores from 0-1.0. Higher scores are better.
Change from Baseline to 12 weeks
Means End Problem-Solving Task
Time Frame: Change from Baseline to 12 weeks
The Means End Problem-Solving Task consists of a series of scenarios, with each one identifying the beginning and end of a story. The subject's task is to come up with the middle of the story. Stories are scored according to how many steps to reaching the end the patient identifies. An increase in effective means generated is expected to drive reduction in suicide ideation. We report the total score, the range was 2-19. Scores higher=better problem-solving.
Change from Baseline to 12 weeks
Emotional Stroop
Time Frame: Change from Baseline to 12 weeks
The emotional Stroop is a test of response inhibition. There are four category conditions: aggression, color, negative, and positive. Scores were derived based on the difference between the median latency of neutral condition subtracted from median latency of category conditions (unit=miliseconds) with higher scores equaling better problem-solving. Score range did not exceed -500 to 500.
Change from Baseline to 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interpersonal Needs Questionnaire
Time Frame: Change from Baseline to 12 weeks, Baseline to 6 months
Feelings of burdensomeness and belongingness will be measured by the Interpersonal Needs Questionnaire (INQ). This measure is 18-item self-report questionnaire. The belonging subscale is 6 items and scores range from 6-42 with higher scores indicating less belonging, the burdensomeness subscale is 9 items and scores range from 9-63 with higher scores indicating greater burdensomeness.
Change from Baseline to 12 weeks, Baseline to 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Suicide Ideation Questionnaire (SIQ).
Time Frame: Change from Baseline to 12 weeks
Suicide Ideation Questionnaire (SIQ) is a 30-item self-report instrument designed to assess thoughts about suicide experienced during the prior month. This measure has strong internal consistency and construct validity. This measure will allow for supplementary investigation of ideation. Scores range from 7-210 with higher equaling worse ideation.
Change from Baseline to 12 weeks
Suicide Ideation Questionnaire (SIQ).
Time Frame: Change from Baseline to 6 months
Suicide Ideation Questionnaire (SIQ) is a 30-item self-report instrument designed to assess thoughts about suicide experienced during the prior month. This measure has strong internal consistency and construct validity. This measure will allow for supplementary investigation of ideation. Scores range from 7-210 with higher equaling worse ideation.
Change from Baseline to 6 months
Suicide-Related Coping Scale
Time Frame: Change from Baseline to 12 weeks
The Suicide-Related Coping Scale captures an individual's perceived ability to use internal and external coping to problem-solve suicidal thoughts and urges. This measure was validated in a Veteran sample. The items in this measure capture the types of skills we expect Veterans to be able to use after learning problem-solving (i.e., "I recognize the circumstances that make me suicidal"). Scores range from 0-68 with higher scores indicating better coping.
Change from Baseline to 12 weeks
Suicide-Related Coping Scale
Time Frame: Change from Baseline to 6 months
The Suicide-Related Coping Scale captures an individual's perceived ability to use internal and external coping to problem-solve suicidal thoughts and urges. This measure was validated in a Veteran sample. The items in this measure capture the types of skills we expect Veterans to be able to use after learning problem-solving (i.e., "I recognize the circumstances that make me suicidal"). Scores range from 0-68 with higher scores indicating better coping.
Change from Baseline to 6 months
Pain Disability Index (PDI)
Time Frame: Change from Baseline to 12 weeks
Pain Disability Index (PDI) is a 7 item measure of the impact of pain on daily activities and social relationships. It will be used to assess disability from pain. The PDI ranges from 0-70 with higher scores indicating worse disability from pain.
Change from Baseline to 12 weeks
Pain Disability Index (PDI)
Time Frame: Change from Baseline to 6 months
Pain Disability Index (PDI) is a 7 item measure of the impact of pain on daily activities and social relationships. It will be used to assess disability from pain.The PDI ranges from 0-70 with higher scores indicating worse disability from pain.
Change from Baseline to 6 months
Columbia-Suicide Severity Rating Scale (C-SSRS)
Time Frame: Change from Baseline to 12 weeks and Baseline to 6 months
Columbia-Suicide Severity Rating Scale (C-SSRS) is the gold standard for suicide assessment and measures level and intensity of suicidal ideation, planning and preparation for suicidal behavior, and method and lethality of recent (past week) and past lifetime suicidal behavior. The intensity of ideation subscale (the summed score from five separate items on Part II; subscale range = 2-25) will be the primary dependent variable for the fully powered clinical trial. The intensity of ideation asks about the intensity of ideation in the past 6 months (e.g., the frequency, duration controllability). Higher scores are equal to greater ideation.
Change from Baseline to 12 weeks and Baseline to 6 months
Brief Pain Inventory (BPI)
Time Frame: Change from Baseline to 12 weeks
Brief Pain Inventory (BPI) measure of pain severity and interference. The total severity composite score ranges from 0-10 with higher scores indicating worse pain. The total pain interference score ranges from 0-10 with higher scores indicating more interference.
Change from Baseline to 12 weeks
Brief Pain Inventory (BPI)
Time Frame: Change from Baseline to 6 months
Brief Pain Inventory (BPI) measure of pain severity and interference. The total severity composite score ranges from 0-10 with higher scores indicating worse pain. The total pain interference score ranges from 0-10 with higher scores indicating more interference.
Change from Baseline to 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Veterans BioMedical Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Rutgers University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Lisa M McAndrew, PhD, VA NJHCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 20, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 6, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 2, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 5R56MH121555 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

If the subject agrees, their data will be submitted to the National Institute of Mental Health Data Archive (NDA) at the National Institutes of Health (NIH). NDA is a large database where deidentified study data from many National Institute of Mental Health (NIMH) studies is stored and managed.

IPD Sharing Time Frame

Every 3 months data is uploaded

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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