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Trial record 5 of 5944 for:    Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

Group ("Project Life Force") vs. Individual Suicide Safety Planning RCT (PLF)

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ClinicalTrials.gov Identifier: NCT03653637
Recruitment Status : Recruiting
First Posted : August 31, 2018
Last Update Posted : November 6, 2018
Sponsor:
Collaborator:
Corporal Michael J. Crescenz VA Medical Center
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Suicide Behavioral: Project Life Force Behavioral: Treatment as Usual Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are assigned to one of two groups in parallel for the duration of the study.
Masking: Single (Outcomes Assessor)
Masking Description: The individual who evaluates the outcomes of interest will not know the assigned condition of the participants.
Primary Purpose: Treatment
Official Title: Group (Project Life Force) vs. Individual Suicide Safety Planning RCT
Actual Study Start Date : October 15, 2018
Estimated Primary Completion Date : June 3, 2022
Estimated Study Completion Date : March 3, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: Project Life Force
A novel, 10-session intervention to enhance currently mandated VA suicide safety planning in a group setting to support its implementation. PLF is a manualized, weekly 90-minute group treatment lasting 10 weeks coinciding with the time frame for enhanced monitoring of Veterans identified as "high-risk". Session content is described in Table 1 (see appendix A). Six of the PLF sessions correspond to a step of the safety plan and teach skills to maximize the use of that particular step of the plan. The use of emotion regulation skills in PLF differs from other DBT interventions in that it focuses primarily on emotion regulation, distraction and developing social support in the specific context of implementing a safety plan. Mindfulness is not covered. PLF is augmented with additional skill modules on physical health management, education pertaining to suicide risk, promoting positive emotion and suicide prevention mobile apps. PLF patients also receive usual care.
Behavioral: Project Life Force
A novel, 10-session group intervention to enhance currently mandated VA suicide safety planning by involving Veterans who are at high-risk for suicidal. The PLF intervention augments the SSP in a group treatment with skills training, and psychoeducation, to maximize use and effectiveness of the plan. Overall, PLF aims to enhance suicide coping skills, safety planning and connection to others. The primary purpose is to enhance the safety plan with skills training in emotion regulation, building of support and distress tolerance, and enable even acutely-suicidal Veterans to be able to implement the steps of the safety plan.
Other Name: PLF

Active Comparator: Treatment-As-Usual
The comparison condition will be an assessment-only treatment-as-usual (TAU). Research team will track number of individual mental health appointments, SPC outreach contacts, and usage patterns of safety plans. Veterans in both randomized conditions will be receiving the mandated monitoring, outreach, and involvement of SPC staff and clinical team management that constitutes standard VA care for suicidal individuals.
Behavioral: Treatment as Usual
The comparison condition will be an assessment-only treatment-as-usual (TAU). Participants in the TAU condition will receive safety planning and specified clinical support, as mandated by their high-risk status.
Other Name: TAU




Primary Outcome Measures :
  1. Columbia Suicide Rating Scale (C-SSRS) [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]

    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.


  2. Suicidal behavior by Chart Abstraction [ Time Frame: 12 Month ]
    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.

  3. Death by suicide by National Death Index Survey Findings [ Time Frame: 12 Month ]
    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.


Secondary Outcome Measures :
  1. Beck Depression Inventory-II Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    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.

  2. Beck Hopelessness Scale Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    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.

  3. Suicide-related Coping Scale Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    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).

  4. Outpatient Mental Health Treatment Utilization [ Time Frame: 12 Month ]
    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.


Other Outcome Measures:
  1. The Group Cohesion Scale-Revised Change [ Time Frame: Weeks 1, 5, 10 ]
    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.

  2. Interpersonal Needs Questionnaire Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    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.

  3. Buss-Perry Aggression Questionnaire Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    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).

  4. Reasons for Living Scale (RFL) - Military Version Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    Reasons for Living Scale - Military Version includes 20 distinct items which were added to Linehan's original list of 48 (known as Reasons for Living). There are six additional categories factors that have been labeled as follows: Survival and Coping Beliefs, Military Values, Responsibility to Family, Fear of Suicide/Disability/Unknown, Moral Objections and Child-Related Concerns. The subscale of Military Values is a new factor reflecting the addition of military items to the original RFL.

  5. Attitudes Towards Suicide Questionnaire [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    The Attitudes Towards Suicide Questionnaire was used to measure attitudes toward suicide. This scale is comprised of 37 items. Each item is rated on a 5-point Likert scale ranging from Strongly Disagree (1) to Strongly Agree (5). The total score of all 37 items was used for evaluation.

  6. Insomnia Severity Index Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    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.

  7. Beck Lethality Scale Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    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.

  8. Beck Suicide Intent Scale Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    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.

  9. Deliberate Self-Harm Inventory (DSHI) Change [ Time Frame: Baseline, 3 Month, 6 Month, 12 Month ]
    Deliberate Self-Harm Inventory is a 17-item, yes/no, self-report questionnaire that explores the number of times and methods that participants have done to hurt themselves intentionally.

  10. Ohio State University Traumatic Brain Injury Identification Method [ Time Frame: Baseline ]
    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.

  11. Mini International Neuropsychiatric Interview [ Time Frame: Baseline ]
    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.

  12. Mini Mental State Exam [ Time Frame: Baseline ]
    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.



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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03653637


Contacts
Contact: Sarah R Sullivan (718) 584-9000 Sarah.Sullivan@va.gov

Locations
United States, New York
James J. Peters VA Medical Center, Bronx, NY Recruiting
Bronx, New York, United States, 10468
Contact: Toy Mordiglia, BS    718-584-9000 ext 6017    Toy.Mordiglia@va.gov   
Contact: Juan C Bandres, MD    (718) 584-9000 ext 6667    juan.bandres2@va.gov   
Principal Investigator: Marianne S. Goodman, MD         
United States, Pennsylvania
Corporal Michael J. Crescenz VA Medical Center, Philadelphia, PA Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Eileen McCarthy-Dorsey    215-823-6029    Eileen.McCarthy-Dorsey@va.gov   
Sponsors and Collaborators
VA Office of Research and Development
Corporal Michael J. Crescenz VA Medical Center
Investigators
Principal Investigator: Marianne S. Goodman, MD James J. Peters Veterans Affairs Medical Center

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03653637     History of Changes
Other Study ID Numbers: MHBB-025-17F
1I01CX001705-01A1 ( U.S. NIH Grant/Contract )
First Posted: August 31, 2018    Key Record Dates
Last Update Posted: November 6, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
Suicide
Safety Plan
Group Treatment
Veterans

Additional relevant MeSH terms:
Suicide
Self-Injurious Behavior
Behavioral Symptoms