Suicide Clinical Trial
— PLFOfficial title:
Group (Project Life Force) vs. Individual Suicide Safety Planning RCT
Verified date | April 2024 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The management of suicide risk is a pressing national public health issue especially among Veterans. This grant consists of two arms: the novel treatment and treatment-as-usual. "Project Life Force" (PLF), a novel suicide safety planning group intervention has been developed to provide a mechanism to develop and enhance the Suicide Safety Plan (SSP) over time. PLF, a 10-session, group intervention, combines cognitive behavior therapy (CBT)/dialectical behavior therapy (DBT) skill based, and psychoeducational approaches, to maximize suicide safety planning development and implementation. Veterans revise their plans over several weeks while learning coping, emotion regulation, and interpersonal skills to incorporate into their safety plans.
Status | Completed |
Enrollment | 206 |
Est. completion date | March 30, 2024 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 89 Years |
Eligibility | Inclusion Criteria: - Discharge from inpatient unit for suicidal ideation or attempts, or placement on the high-risk suicide list maintained by suicide prevention coordinators - Completion of a safety plan during the past 6 months prior to entry - Concurrence from the patient's mental health provider for the Veteran to participate in the study and the provider is willing to work with the research team. Exclusion Criteria: - Unable to provide informed consent or complete study requirements - Unable to speak English - Cognitive difficulties that impair consent capacity - Unable or unwilling to provide at least one verifiable contact for emergency or tracking purposes - Unable to attend outpatient group treatment program or tolerate group therapy format - Active alcohol or opiate dependence requiring medically supervised withdrawal - Schizophrenia diagnosis - Participation in another intervention RCT |
Country | Name | City | State |
---|---|---|---|
United States | James J. Peters VA Medical Center, Bronx, NY | Bronx | New York |
United States | Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Corporal Michael J. Crescenz VA Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | The Group Cohesion Scale-Revised Change | Group cohesion will be measured by the The Group Cohesion Scale-Revised, a 25-item self-report measure that assesses aspects of group cohesion including communication, interaction, member retention, decision making, vulnerability among group members and consistency between group and individual goals with a four-point scale. This scale will be used for participants randomized to the PLF treatment at 3 times points before a group session. The scale demonstrated high validity and reliability in research settings and was found to be sensitive to change in a psychodrama group treatment. | Weeks 1, 5, 10 | |
Other | Interpersonal Needs Questionnaire Change | The Interpersonal Needs Questionnaire will be used to measure thwarted belongingness. While several versions exist, the investigators will use the 10-item version as it demonstrated the best, most consistent model fit in confirmatory factor analyses and consistently predicted concurrent suicidal ideation. | Baseline, 3 Month, 6 Month, 12 Month | |
Other | Buss-Perry Aggression Questionnaire Change | The Buss-Perry Aggression Questionnaire assesses four aspects of aggressive behavior: physical aggression, verbal aggression, anger and hostility. Participants rank statements about their temperament using a 7-point Likert scale ranging from 1 (extremely uncharacteristic of me) to 7 (extremely characteristic of me). | Baseline, 3 Month, 6 Month, 12 Month | |
Other | Insomnia Severity Index Change | The 7-item Insomnia Severity Index will be used to assess important health domains. It is used to assess the severity of both nighttime and daytime components of insomnia. The seven answers are added up to get a total score. | Baseline, 3 Month, 6 Month, 12 Month | |
Other | Beck Lethality Scale Change | Medical seriousness of attempts was assessed using the Beck Lethality Scale. It measures the degree of the severity of medical injury resulting from the suicide attempt. The Beck Lethality Scales includes eight items that measure the medical lethality of previous suicide attempts (e.g., shooting, jumping, and drug overdose). Each scale is rated from 0 to 10, based on an examination of the patient's physical condition on admission, review of the medical charts, and consultation with the attending physician. | Baseline, 3 Month, 6 Month, 12 Month | |
Other | Beck Suicide Intent Scale Change | Suicidal intent associated with suicide attempts was assessed using Beck's Suicide Intent Scale. Beck's SIS contains 20 items each scoring from 1 to 3 points. Total score of 15-19 was recorded as low intent, score 20-28 was recorded as medium intent, and score 29 and above was recorded as high intent. | Baseline, 3 Month, 6 Month, 12 Month | |
Other | Ohio State University Traumatic Brain Injury Identification Method | The Ohio State University Traumatic Brain Injury Identification Method is a standardized, 3-5-minute structured interview designed elicit a person's lifetime history of TBI. | Baseline | |
Other | Mini International Neuropsychiatric Interview | The Mini International Neuropsychiatric Interview is a short diagnostic structured interview developed to explore disorders according to Diagnostic and Statistical Manual diagnostic criteria. The Mini International Neuropsychiatric Interview will be used to determine the presence/absence of (lifetime) psychiatric symptoms. | Baseline | |
Other | Mini Mental State Exam | The Mini Mental State Exam is a questionnaire used to measure cognitive impairment. This scale has good validity and construct validity and will be used to examine if participants are cognitively able to participate in the study. | Baseline | |
Primary | Columbia Suicide Rating Scale (C-SSRS) | Columbia Suicide Rating Scale (C-SSRS) will be used to count prospective or treatment emergent suicidal behaviors. The CSSRS has been used in many treatment trials, and to measure treatment emergent suicidal events during pharmacotherapy.
C-SSRS contains a subscale on suicidal ideation which is scored from 1-5; higher numbers indicate increased suicidal thinking. The definition of suicide attempt for the primary outcome will consist of any actual suicide attempt, aborted suicide attempt, or interrupted suicide attempt according to the CSSR-S. |
Baseline, 3 Month, 6 Month, 12 Month | |
Primary | Suicidal behavior by Chart Abstraction | An independent research assessor who is blinded to study condition will complete all outcome assessments. Data for all types of suicidal behavior including suicides, suicide attempts, interrupted attempts, aborted attempts, and preparatory behavior for suicide, will be obtained. The nomenclature and definitions for suicide-related behaviors will follow the Center for Disease Control and Prevention's (CDC) definitions. Suicidal behavior over the 12-month time frame is a cumulative outcome such that detection of suicidal behavior at any of the outcome points, or by any method, leads to a "positive" indication for the suicidal behavior composite. | 12 Month | |
Primary | Death by suicide by National Death Index Survey Findings | At month 42, each site's research assistant will query the site's state vital statistics registry for all individuals on this list. For all those who are found to be deceased, data will be abstracted pertaining to his/her death and the probability of suicide from the Death Certificate. The 12-month delay in review is necessary because of the well-known lag in recording deaths in state vital statistics registries. | 12 Month | |
Secondary | Beck Depression Inventory-II Change | Depression will be measured with the Beck Depression Inventory-II. This scale consisting of 21 items and scored based on a Likert scale, has high internal consistency (Cronbach coefficient = .92). Each question has a set of at least four possible answer choices, ranging in intensity. When the test is scored, a value of 0 to 3 is assigned for each answer and then the total score is used to quantify the participant's degree of depression from 0 = no depression to 63 = maximally severe depression. | Baseline, 3 Month, 6 Month, 12 Month | |
Secondary | Beck Hopelessness Scale Change | Hopelessness is assessed with the Beck Hopelessness Scale, a 20-item self-report measure with true-false items that assess hopelessness and the extent of positive and negative beliefs about the future. Summed scores range from 0 to 20. Scores provide a measure of the severity of self-reported hopelessness: 0-3 minimal, 4-8 mild, 9-14 moderate, and 15-20 severe. Adequate reliability and concurrent validity data exist for this measure, which has been shown to be predictive of eventual suicide in psychiatric inpatients. | Baseline, 3 Month, 6 Month, 12 Month | |
Secondary | Suicide-related Coping Scale Change | Suicide-related coping will be evaluated by the Suicide-related Coping Scale, a 21-item self-report measure developed by Stanley and colleagues to evaluate appraisal of one's ability to cope with suicidal ideation and urges, as well as ability to use the Safety Plan. Examples of items include: "I am at the mercy of my suicidal thoughts", "I have several things I can do to get through a suicidal crisis". The scale has high internal consistency reliability (Cronbach's = 0.88) and demonstrated sensitivity to change in SAFEVET (t(65) = 6.8, p < .001;Dr. Stanley, personal communication). | Baseline, 3 Month, 6 Month, 12 Month | |
Secondary | Outpatient Mental Health Treatment Utilization | Outpatient Mental Health Treatment Utilization will be quantified Using CPRS investigators will count the number of outpatient non-PLF mental health visits attended by participants three months prior to the intervention and compare it to the number of outpatient visits attended during and three months post intervention. | 12 Month | |
Secondary | Drug Abuse Screening Test 10 (DAST-10) | The DAST-10 is a brief, 10-item self-report assesses consequences related to drug abuse, excluding alcohol and tobacco. This is a 10-item questionnaire with no-yes answers (0-1). Higher scores are positively correlated with higher levels of drug dependence. Minimum score = 0 : maximum score = 10. | 12 Month | |
Secondary | Alcohol Use Disorders Identification Test-Consumption (AUDIT-C) | The AUDIT-C is a widely used 3-item self-report screen for hazardous or harmful alcohol consumption that is based off of the 10-item original AUDIT. | 12 Month |
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