Suicide Prevention for Patients With Chronic Pain

NCT04490265 | Completed Results DMC

• 1 other identifier: 5R56MH121555
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide; Chronic Pain

Outcome Measures

Primary Outcomes (6)

• Social Problem-solving Inventory - Patient Report

  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

  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

  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

  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

• Iowa Gambling Task

  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

• Emotional Stroop

  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 Outcomes (1)

• Interpersonal Needs Questionnaire

  Change from Baseline to 12 weeks, Baseline to 6 months

Other Outcomes (9)

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  Change from Baseline to 12 weeks and Baseline to 6 months

• Suicide Ideation Questionnaire (SIQ).

  Change from Baseline to 12 weeks

• Suicide Ideation Questionnaire (SIQ).

  Change from Baseline to 6 months

Study Arms (2)

Problem-Solving Treatment

EXPERIMENTAL

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

Supportive Psychotherapy

PLACEBO COMPARATOR

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

Interventions

Problem-solving treatment BEHAVIORAL

included in arm descriptions

Problem-Solving Treatment

Supportive Psychotherapy BEHAVIORAL

included in arm descriptions

Supportive Psychotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Veterans BioMedical Research Institute: lead
• Rutgers University: collaborator

Study Sites (1)

VA NJHCS

East Orange, New Jersey, 07018, United States

Location

MeSH Terms

Conditions

Suicide; Chronic Pain

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Lisa McAndrew
• Organization: US Department of Veterans Affairs

lisa.mcandrew@va.gov

862-400-3317

Study Officials

• Lisa M McAndrew, PhD

  VA NJHCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2020
• First Posted: July 29, 2020
• Study Start: May 20, 2020
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Every 3 months data is uploaded

Locations

US (1)