NCT03682406

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 24, 2018

Completed
7 days until next milestone

Study Start

First participant enrolled

October 1, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 28, 2019

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2022

Completed
Last Updated

April 21, 2022

Status Verified

April 1, 2022

Enrollment Period

1.2 years

First QC Date

September 21, 2018

Last Update Submit

April 13, 2022

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    6 months

  • 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)

    6 months

  • 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).

    6 months

  • 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.

    6 months

  • 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).

    6 months

  • Changes in Outcome Questionnaire-45

    45-item tracking/assessment instrument measuring overall symptom distress, which ranges from 0 (low distress) to 180 (high distress)

    6 months

  • 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)

    6 months

Other Outcomes (1)

  • Group Cohesion Scale

    3 months

Study Arms (2)

CAMS-G

EXPERIMENTAL

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

Care as Usual

OTHER

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

Interventions

CAMS-GBEHAVIORAL

Group-based suicide-specific intervention based upon the Collaborative Assessment and Management of Suicidality.

CAMS-GCare as Usual

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robley Rex VAMC

Louisville, Kentucky, 40206-1433, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

SuicideSelf-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Eleanor Lederer, MD

    Louisville VAMC

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessors will remain blinded to the treatment condition for all participants.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned in even numbers to CAMS-G or care as usual.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Facilitator

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 24, 2018

Study Start

October 1, 2018

Primary Completion

December 28, 2019

Study Completion

April 1, 2022

Last Updated

April 21, 2022

Record last verified: 2022-04

Data Sharing

IPD Sharing
Will not share

Locations