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CAMS-G Group Therapy for Suicidal Veterans

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ClinicalTrials.gov Identifier: NCT03682406
Recruitment Status : Active, not recruiting
First Posted : September 24, 2018
Last Update Posted : February 21, 2020
Sponsor:
Collaborator:
Rocky Mountain MIRECC for Suicide Prevention
Information provided by (Responsible Party):
Lora Johnson, Louisville VA Medical Center

Brief Summary:
The primary aim of this pilot study is to determine the feasibility and acceptability of CAMS-G. Our aim is to determine if CAMS-G is an effective treatment and whether it has the potential to be tested in a large-scale setting.

Condition or disease Intervention/treatment Phase
Suicide and Self-harm Behavioral: CAMS-G Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be assigned in even numbers to CAMS-G or care as usual.
Masking: Single (Outcomes Assessor)
Masking Description: The outcomes assessors will remain blinded to the treatment condition for all participants.
Primary Purpose: Treatment
Official Title: Pilot Study of the Collaborative Assessment and Management of Suicidality - Group (CAMS-G)
Actual Study Start Date : October 1, 2018
Actual Primary Completion Date : December 28, 2019
Estimated Study Completion Date : December 28, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: CAMS-G
CAMS-G is an group-based adaptation of the Collaborative Assessment and Management of Suicidality (CAMS) that has been developed to address perceived burdensomeness and thwarted belongingness, two drivers of suicide risk. Ongoing assessment and treatment planning are completed using the CAMS Suicide Status Form in the group modality, with involvement from group members and group facilitators. Driver-focused intervention strategies and group process also occur in the group based upon the unique needs of the group members. Groups are 90-minutes in length and occur on a weekly basis.
Behavioral: CAMS-G
Group-based suicide-specific intervention based upon the Collaborative Assessment and Management of Suicidality.

Care as Usual
Care as usual includes access to all existing forms of treatment that currently exist at the Robley Rex VAMC and affiliated CBOCs, such as individual and group psychotherapy, suicide prevention programming and case management, psychiatric care, social work services, and substance use disorder counseling. We will essentially track the control condition over time as they engage in the typical services provided to suicidal Veterans through the Robley Rex VAMC. The CAMS-G study participants will have access to the same services delivered as part of care as usual, with the only difference being their participation in the CAMS-G treatment for suicidality.
Behavioral: CAMS-G
Group-based suicide-specific intervention based upon the Collaborative Assessment and Management of Suicidality.




Primary Outcome Measures :
  1. Self-Harm Behavior Questionnaire [ Time Frame: 6 months ]
    Self-report measure composed of four sections, each assessing different facets of suicidality. Each subsection will be scored for occurrence and severity, including non-suicidal self-injury, suicide attempts, suicide threats, and suicidal ideation.

  2. Changes Beck Scale for Suicidal Ideation [ Time Frame: 6 months ]
    19-item assessment used to evaluate the current intensity of the patient's specific attitudes toward, behavior, and plans to commit suicide. Total score will be reported which ranges from 0 (no suicidal ideation) to 38 (high suicidal ideation)

  3. Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness [ Time Frame: 6 months ]
    12-item measure of the extent to which individuals feel connected to others (i.e., belongingness) and like a burden on people in their lives (i.e., perceived burdensomeness). Subscale total scores for thwarted belongingness and perceived burdensomeness will be reported. For thwarted belongingness, scores range from 9 (low) to 63 (high). For perceived burdensomeness, scores range from 6 (low) to 42 (high).

  4. Changes in Beck Hopelessness Scale [ Time Frame: 6 months ]
    20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents over the previous week. Scores range from 0 to 20 representing nil (0-3), mild (4-8), moderate (9-14), and severe (> 14) levels of hopelessness.

  5. Changes in Reasons for Living Inventory [ Time Frame: 6 months ]
    48-item measure that rates the importance of different reasons why people choose not to kill themselves. Total score will be reported, which ranges from 48 (low reasons for living) to 288 (High reasons for living).

  6. Changes in Outcome Questionnaire-45 [ Time Frame: 6 months ]
    45-item tracking/assessment instrument measuring overall symptom distress, which ranges from 0 (low distress) to 180 (high distress)

  7. Changes in Optimism and Hope Scale [ Time Frame: 6 months ]
    14-item self-report measure combining a measure of dispositional optimism and trait hopefulness, with scores ranging from 0 (low) to 42 (high)


Other Outcome Measures:
  1. Group Cohesion Scale [ Time Frame: 3 months ]
    9-item scale used in this study to assess participants' perceptions of how well the group members form feelings of interpersonal bonds in the group, scores range from 1 (low) to 63 (high)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. Adult 18-89 years old
  2. Endorses suicidality (acknowledges recent/current suicidal thoughts, plans, and/or behavior and wish to work on it clinically).
  3. Veteran is willing to engage in treatment around the suicidality.
  4. Eligible to receive care at the Robley Rex VA Medical Center
  5. English speaking based on the need to participate in group treatment

Exclusion Criteria:

  1. CAMS-G is designed to be as broadly inclusive as possible. On a case-by-case basis, psychopathology and/or cognitive limitations that significantly interfere with the patient's ability to interact effectively and/or benefit from a group intervention could preclude the patient from participating in the group.
  2. A Veteran could be excluded if he or she has a circumstance that could be harmful to other members who are already in the group (e.g., we will not enroll a sex offender who is working on that issue into a group with a victim of sexual abuse).
  3. A Veteran who is unwilling to meaningfully engage in treatment (e.g., unwilling to reduce access to lethal means, directly address suicidal drivers, engage in collaborative treatment planning, develop a safety plan, participate in group discussion, etc.) is inappropriate for participation in the group on an outpatient basis.
  4. Veterans will be excluded if they have previously been in a CAMS-G treatment

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): NCT03682406


Locations
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United States, Kentucky
Robley Rex VAMC
Louisville, Kentucky, United States, 40206-1433
Sponsors and Collaborators
Louisville VA Medical Center
Rocky Mountain MIRECC for Suicide Prevention
Investigators
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Study Chair: Eleanor Lederer, MD Louisville VAMC
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Responsible Party: Lora Johnson, Research Facilitator, Louisville VA Medical Center
ClinicalTrials.gov Identifier: NCT03682406    
Other Study ID Numbers: 00467
First Posted: September 24, 2018    Key Record Dates
Last Update Posted: February 21, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms