NCT03533075

Brief Summary

The overall objective is to determine the acceptability and feasibility of the Teachable Moment Brief Intervention (TMBI) + follow-up consultation for Veterans treated on an inpatient psychiatry unit following a suicide attempt. The study will also determine whether there is a signal of effectiveness supporting the TMBI in improving the recovery trajectory of Veterans following discharge to the community.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2018

Typical duration 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

Study Start

First participant enrolled

April 23, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 26, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2020

Completed
Last Updated

September 11, 2020

Status Verified

September 1, 2020

Enrollment Period

2.4 years

First QC Date

April 26, 2018

Last Update Submit

September 10, 2020

Conditions

Outcome Measures

Primary Outcomes (6)

  • Changes in Stages of Change Questionnaire, which measures motivation

    18-item measure that measures motivation to engage in treatment/work on problems. Total score will be summed from all items, with range from 18 (low motivation) to 90 (high motivation). Four subscales will also be reported as follows: Precontemplation ranges from 5 (low) to 25 (high) with higher scores indicating higher motivation. Contemplation ranges from 4 (low) to 20 (high) with higher scores indicating higher motivation. Action ranges from 5 (low) to 25 (high) with higher scores indicating higher motivation. Maintenance ranges from 4 (low) to 20 (high) with higher scores indicating higher motivation.

    3 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).

    3 months

  • Changes in State Hope Scale

    6-item measure of ongoing self-directed thinking. Total score will be reported, which ranges from 6 (low hope) to 48 (high hope).

    3 months

  • Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness.

    15-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).

    3 months

  • Changes in Beck Scale for Suicide 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)

    3 months

  • Suicide Attempt Self-Injury Count

    two-page instrument determining for the first, most recent, and most severe suicide attempt or non-suicidal self-injury (SASI) the date, method of SASI attempt used in index and previous attempts according to the definitions of Linehan et al. (e.g., using definitions of self-inflicted injuries which include situations of actual tissue damage and situations where tissue damage would have occurred except for outside intervention or sheer luck \[e.g., firearm jammed\]), intent to die (i.e., intent to die, ambivalent, no intent to die), highest level of medical treatment received, and lethality

    3 months

Secondary Outcomes (3)

  • Outpatient Health Services Engagement

    12 months

  • Acute Care Health Services

    12 months

  • Self-Directed Violence

    12 months

Study Arms (2)

Teachable Moment Brief Intervention

EXPERIMENTAL

The TMBI is informed by evidence based strategies to collaboratively identify 1) drivers of suicidal ideation, 2) functional aspects of the recent suicide attempt, 3) the patient's relationship with the concept of suicide, 4) what has been lost and gained as a result of the suicide attempt, 5) short term management suicide prevention management strategies, and 6) documentation of factors to address in a suicide-specific treatment plan.

Behavioral: Teachable Moment Brief Intervention

Care as Usual

NO INTERVENTION

Usual care at Veterans Affairs Medical Centers (VAMC) for Veterans who have attempted suicide involves psychiatric evaluation/treatment and ongoing medical stabilization.

Interventions

Behavioral intervention informed by Collaborative Assessment and Management of Suicidality and Dialectical Behavior Therapy/Cognitive Behavior Therapy to assist in positive recovery trajectory following a suicide attempt

Teachable Moment Brief Intervention

Eligibility Criteria

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

You may qualify if:

  • Veteran service member
  • Recently admitted to an inpatient psychiatry unit at the VAMC site following a suicide attempt
  • or more years of age
  • Consents to participate in baseline and follow-up interviews and gives permission to review records for previous year and subsequent year.
  • Consents to randomization and participation in TMBI + follow-up or Care as Usual
  • Consents to audio recording in order for PI to conduct adherence rating

You may not qualify if:

  • Significant psychosis, cognitive, or other problems that prevent participant from understanding the study procedures or renders them unable to provide informed consent (suggesting that psychosocial therapeutic care is contra-indicated)
  • Judicially-ordered to treatment (e.g., subsequent to domestic violence) such that participation in study procedures could not be considered voluntary and participant is not free to drop out without significant negative consequences.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Robley Rex VA Medical Center

Louisville, Kentucky, 40206-1433, United States

Location

Related Publications (1)

  • Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Psychosocial interventions for self-harm in adults. Cochrane Database Syst Rev. 2021 Apr 22;4(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

MeSH Terms

Conditions

Suicide, Attempted

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Stephen O'Connor, PhD

    Robley Rex VA Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor 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 TMBI + follow-up consultation or care as usual.
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Facilitator

Study Record Dates

First Submitted

April 26, 2018

First Posted

May 22, 2018

Study Start

April 23, 2018

Primary Completion

August 30, 2020

Study Completion

August 30, 2020

Last Updated

September 11, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

Locations