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N/A N=44 Randomized Double-blind Treatment

Suicide Prevention for Patients With Chronic Pain

Suicide · Chronic Pain

Enrolled (actual)
44
Serious AEs
13.6%
Results posted
Jul 2025
Primary outcome: Primary: Social Problem-solving Inventory - Patient Report — 8.12; 3.64 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Problem-solving treatment (Behavioral); Supportive Psychotherapy (Behavioral)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Veterans BioMedical Research Institute
Primary completion
Dec 2023

Outcome Measures

OutcomeResultp-value
PRIMARY
Social Problem-solving Inventory - Patient Report
8.31; -.24
PRIMARY
Social Problem-solving Inventory - Patient Report
8.31; -.24
PRIMARY
Emotional Go No Go
-.01; .06
PRIMARY
Means End Problem-Solving Task
-1.36; 0.29
PRIMARY
Iowa Gambling Task
23.33; 26.14
PRIMARY
Emotional Stroop
59.21; 13.50; 123.00; 59.49; 55.50; 72.71
SECONDARY
Interpersonal Needs Questionnaire
-2.37; -.81; -4.37; -.5; -.4; -.79

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04490265). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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