Suicide Prevention for Patients With Chronic Pain

Chronic Pain Clinical Trial

Official title:

Suicide Prevention for Patients With Chronic Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04490265
• Other study ID #: 5R56MH121555
• Status: Completed
• Phase: N/A
• Start date: May 20, 2020
• Est. completion date: December 27, 2023

Study information

• Verified date: May 2024
• Source: Veterans BioMedical Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 27, 2023
• Est. primary completion date: December 27, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Suicide
• Suicide Prevention

Intervention

Behavioral:
• Problem-solving treatment
included in arm descriptions
• Supportive Psychotherapy
included in arm descriptions

Locations

Country	Name	City	State
United States	VA NJHCS	East Orange	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
Veterans BioMedical Research Institute	Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Columbia-Suicide Severity Rating Scale (C-SSRS)	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
Other	Columbia-Suicide Severity Rating Scale (C-SSRS)	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 6 months
Other	Suicide Ideation Questionnaire (SIQ).	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
Other	Suicide Ideation Questionnaire (SIQ).	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
Other	Suicide-Related Coping Scale	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
Other	Suicide-Related Coping Scale	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
Other	Pain Disability Index (PDI)	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
Other	Pain Disability Index (PDI)	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
Other	Brief Pain Inventory (BPI)	Brief Pain Inventory (BPI) is a 10 item measure of pain severity and interference. The total score is sensitive to change with 1 point considered clinically meaningful. Scores range from 0-10 with higher scores indicating worse pain.	Change from Baseline to 12 weeks
Other	Brief Pain Inventory (BPI)	Brief Pain Inventory (BPI) is a 10 item measure of pain severity and interference. The total score is sensitive to change with 1 point considered clinically meaningful. Scores range from 0-10 with higher scores indicating worse pain.	Change from Baseline to 6 months
Primary	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
Primary	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
Primary	Social problem-solving inventory - caregiver report	The social problem-solving inventory - caregiver report measures problem-solving that is sensitive to change. In clinical research, the social problem-solving inventory - caregiver report has been successfully used to elicit meaningful 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
Primary	Social problem-solving inventory - caregiver report	The social problem-solving inventory - caregiver report measures problem-solving that is sensitive to change. In clinical research, the social problem-solving inventory - caregiver report has been successfully used to elicit meaningful 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
Primary	Emotional Go No Go	Measures attention and impulse inhibition. Inhibiting impulses is a key component of preventing impulsive behavior that can lead to suicide. Indeed the Go no/go has been shown to predict suicidal behavior and our preliminary data suggests it is responsive to treatment for Veterans with chronic pain and suicidal ideation. We will use the emotional go no go. Raw score correct range = 0 - 360	Change from Baseline to 12 weeks
Primary	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. This instrument captures a crucial element of problem-solving: identifying the steps (i.e., means) that will lead to goal attainment (i.e., end). This aspect of problem-solving is directly relevant to patients with pain whose limited set of identified means includes suicide. An increase in effective means generated is expected to drive reduction in suicide ideation. The measure has been used in suicide research and has shown that suicide attempters generate fewer relevant means than both non-suicidal psychiatric controls and non-psychiatric controls. Scores range from 0-1 with higher=better problem-solving.	Change from Baseline to 12 weeks
Primary	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
Primary	Emotional Stroop	The emotional Stroop is a test of response inhibition, a critical skill to stop suicidal behavior. Scores range from 0-125 with higher scores equaling better problem-solving	Change from Baseline to 12 weeks
Secondary	Interpersonal Needs Questionnaire	Feelings of burdensomeness and belongingness will be measured by the Interpersonal Needs Questionnaire (INQ). This measure is 18-item self-report questionnaire.	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.