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CAMS-G Group Therapy for Suicidal Veterans

Primary Purpose

Suicide and Self-harm

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CAMS-G
Sponsored by
Louisville VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide and Self-harm

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robley Rex VAMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

CAMS-G

Care as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Self-Harm Behavior Questionnaire
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.
Changes Beck Scale for Suicidal Ideation
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)
Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness
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).
Changes in Beck Hopelessness Scale
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.
Changes in Reasons for Living Inventory
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).
Changes in Outcome Questionnaire-45
45-item tracking/assessment instrument measuring overall symptom distress, which ranges from 0 (low distress) to 180 (high distress)
Changes in Optimism and Hope Scale
14-item self-report measure combining a measure of dispositional optimism and trait hopefulness, with scores ranging from 0 (low) to 42 (high)

Secondary Outcome Measures

Full Information

First Posted
September 21, 2018
Last Updated
April 13, 2022
Sponsor
Louisville VA Medical Center
Collaborators
Rocky Mountain MIRECC for Suicide Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03682406
Brief Title
CAMS-G Group Therapy for Suicidal Veterans
Official Title
Pilot Study of the Collaborative Assessment and Management of Suicidality - Group (CAMS-G)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2018 (Actual)
Primary Completion Date
December 28, 2019 (Actual)
Study Completion Date
April 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Louisville VA Medical Center
Collaborators
Rocky Mountain MIRECC for Suicide Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
Detailed Description
A total of 60 patients from either the Robley Rex VAMC inpatient psychiatry unit or outpatient clinics will be enrolled in the study. If the Veteran is referred from inpatient psychiatry, study staff will meet with the Veteran to determine eligibility and consent the Veterans on the inpatient unit prior to discharge. A phone interview will be scheduled to complete the baseline interview after the Veteran has been discharged from the inpatient psychiatry unit. Outpatient referrals will be handled similarly. Whenever possible, to reduce participant burden, the study team will meet Veterans at a community based outpatient clinic (CBOC) to consent outpatients either immediately prior to or after a scheduled appointment. A phone interview will be scheduled to complete the baseline prior to the start of their group. Patients will then be randomized to either (a) an experimental group receiving CAMS-G or (b) a group receiving care as usual. All study participants will then complete telephone follow-up assessments at 1-, 3-, and 6-month time points administered by members of the research team. Dr. Gutierrez and his study team will rate the CAMS-G sessions for adherence to the treatment manual. Individual Veterans remain in the CAMS-G sessions until their suicidal crisis is resolved. The baseline assessment battery will take approximately 60 minutes and the 1-, 3-, and 6-month assessment batteries will take approximately 45 minutes. The Client Satisfaction Questionnaire will be administered at three- and six-month follow-up for each study participant. This will allow reflection on the acceptability and perceived utility of CAMS-G. Notes will be kept on patients who decided to drop out of the intervention and/or the study. The outcome of this aim is evidence that the final CAMS-G manual and study procedures that would be used in an efficacy trial are acceptable to participants. The investigators will examine the mean and standard deviation for the total score and individual items to determine if study participants report acceptable ratings of satisfaction. The investigators will review the responses to open ended questions regarding what Veterans perceived as being helpful about their group experience and what they could do in the future if they become suicidal. The investigators will tabulate average scores and standard deviations for the overall rating and each individual item on the CAMS-G Rating Scale to determine whether the facilitators maintained fidelity to the treatment manual over the course of the study. The investigators will tally the different services received by study participants in order to accurately describe what care as usual consisted of for all study participants, regardless of their assigned treatment condition. This will also the investigators to control for any major differences in care as usual between treatment conditions, for example more individual psychotherapy for one condition, when examining between group differences on outcomes of interest. At the termination of data collection, the investigators will complete a data cleansing process. Descriptive statistics for demographic and clinical variables will be tabulated. All scales will be scored and subscales described. This process will include examining the data for missing values, appropriate ranges, and outliers, with transformations to skewed data applied as needed. Although the randomization design should ensure balance between the two groups, it is essential to control for any known confounders in the design and analysis to prevent a biased assessment of the suicide assessment effect. Any baseline demographic or clinical variables found to be statistically significant in the analysis and significantly associated with the outcomes of interest will be included as covariates in all analytic models. Dropouts and missing data. The investigators will use an intent-to-treat sample to complete our analyses. That is, all participants who provide consent, are randomized to a treatment condition, and attend at least one group therapy session will be included in the analyses regardless of whether they drop out or complete a full course of group therapy. To understand whether treatment drops were completely random, random, or informative, the investigators will analyze our missing data and adjust our interpretation of the results accordingly. The investigators will use generalized linear mixed models (GLMM) to measure differences at 1-, 3-, and 6-months follow-up between veterans in the CAMS-G treatment condition and those in the control treatment condition on constructs of Hopelessness, Thwarted Belongingness, Perceived Burdensomeness, Overall Symptom Distress, and Reasons for Living. The investigators will use Poisson or similar variant of generlized linear mixed modeling (GLMM) for skewed and count data to measure differences at 1-, 3-, and 6-months follow-up between Veterans in the CAMS-G treatment condition and those in the control treatment condition on severity of suicidal ideation and incidence of self-directed violence.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned in even numbers to CAMS-G or care as usual.
Masking
Outcomes Assessor
Masking Description
The outcomes assessors will remain blinded to the treatment condition for all participants.
Allocation
Randomized
Enrollment
41 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAMS-G
Arm Type
Experimental
Arm Description
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.
Arm Title
Care as Usual
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CAMS-G
Intervention Description
Group-based suicide-specific intervention based upon the Collaborative Assessment and Management of Suicidality.
Primary Outcome Measure Information:
Title
Self-Harm Behavior Questionnaire
Description
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.
Time Frame
6 months
Title
Changes Beck Scale for Suicidal Ideation
Description
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)
Time Frame
6 months
Title
Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness
Description
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).
Time Frame
6 months
Title
Changes in Beck Hopelessness Scale
Description
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.
Time Frame
6 months
Title
Changes in Reasons for Living Inventory
Description
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).
Time Frame
6 months
Title
Changes in Outcome Questionnaire-45
Description
45-item tracking/assessment instrument measuring overall symptom distress, which ranges from 0 (low distress) to 180 (high distress)
Time Frame
6 months
Title
Changes in Optimism and Hope Scale
Description
14-item self-report measure combining a measure of dispositional optimism and trait hopefulness, with scores ranging from 0 (low) to 42 (high)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Group Cohesion Scale
Description
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)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult 18-89 years old Endorses suicidality (acknowledges recent/current suicidal thoughts, plans, and/or behavior and wish to work on it clinically). Veteran is willing to engage in treatment around the suicidality. Eligible to receive care at the Robley Rex VA Medical Center English speaking based on the need to participate in group treatment Exclusion Criteria: 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. 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). 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. Veterans will be excluded if they have previously been in a CAMS-G treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eleanor Lederer, MD
Organizational Affiliation
Louisville VAMC
Official's Role
Study Chair
Facility Information:
Facility Name
Robley Rex VAMC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206-1433
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34780099
Citation
Gutierrez PM, Johnson L, Podlogar MC, Hagman S, Muehler TA, Hanson J, Pierson JT, Brown AA, O'Connor S. Pilot study of the Collaborative Assessment and Management of Suicidality-Group. Suicide Life Threat Behav. 2022 Apr;52(2):244-255. doi: 10.1111/sltb.12817. Epub 2021 Nov 15.
Results Reference
result

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CAMS-G Group Therapy for Suicidal Veterans

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