Clinical trial NCT03533075: Teachable Moment Brief Intervention for Veterans Following a Suicide Attempt
Official title: A Pilot Effectiveness Trial of the Teachable Moment Brief Intervention (TMBI) for Veterans Hospitalized Following a Suicide Attempt
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Suicide, Attempted
Lead sponsor: Louisville VA Medical Center
Sponsor class: FED
Collaborators: name: University of Louisville
First posted: 2018-05-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned in even numbers to TMBI + follow-up consultation or care as usual.
Primary purpose: TREATMENT

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.

Detailed description: A total of 50 patients will be recruited from the inpatient psychiatry unit for the study. A member from the research team will obtain informed consent for the participants and then administer the baseline assessment battery. Patients will then be randomized to either (a) an experimental group receiving TMBI + follow-up consultation or (b) a group receiving care as usual. Patients randomized to the experimental group will receive the intervention prior to discharge from the hospital, most likely on the same day as the baseline assessment battery. Patients receiving the experimental intervention will then be asked to complete a brief post-intervention client satisfaction survey administered by a research team member. All study participants will then complete telephone follow-up assessments at 1 and 3-month time points administered by members of the research team and supervised by the PI. Additionally, patient electronic medical records will be abstracted to document the following health services and clinical characteristics in the 12 months following enrollment in the study: death for any reason, inpatient hospitalization (both medical/surgical and psychiatric), emergency department visits, suicide attempt and other forms of self-directed violence, all outpatient appointments with VA service providers, and diagnosis. The PI will rate the TMBI sessions for the interventionists. When the PI delivers the intervention, a trained member of the research team will review the PI's sessions and rate for adherence. The intervention will consist of no more than 90 minutes (expected mean is 45 minutes for the intervention based upon previous studies of the TMBI) of 1:1 interaction with a study clinician. The baseline assessment battery will take approximately 30 minutes, the post-intervention measure will take approximately 5 minutes, and the 1 and 3-month assessment batteries will take approximately 30 minutes. The PI and potentially 2 to 3 members of the Suicide Prevention Program will provide the intervention to \~25 randomized patients.

Notes will be kept on patients who decided to drop out of the intervention and/or the study. We will examine the mean and standard deviation for the total score and individual items on the Client Satisfaction Questionnaire. Notes will be kept documenting all contacts for recruitment and the number of eligible patients per month. Reasons for inclusion and exclusion of potential participants will be documented as well as reasons participants give for choosing not to participate. Number of patients enrolled and randomized each month will be documented. Notes will be kept of rates of on-time outcome assessments and days late and any assessments missed or participants lost to contact.

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. 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 brief intervention effect. Any baseline demographic or clinical variables found to be statistically significant in the analysis will be included as covariates in all analytic models. We will use an intent-to-treat sample to complete our analyses. We will utilize mixed-effects regression models to obtain between-groups effect sizes for the impact of the TMBI + consultation on elevating motivation, hope, reasons for living and social connection.

Eligibility criteria: Inclusion Criteria:

1. Veteran service member
2. Recently admitted to an inpatient psychiatry unit at the VAMC site following a suicide attempt
3. 18 or more years of age
4. Consents to participate in baseline and follow-up interviews and gives permission to review records for previous year and subsequent year.
5. Consents to randomization and participation in TMBI + follow-up or Care as Usual
6. Consents to audio recording in order for PI to conduct adherence rating

Exclusion Criteria:

1. 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)
2. 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.

Primary outcomes:
measure: Changes in Stages of Change Questionnaire, which measures motivation
timeFrame: 3 months
measure: Changes in Reasons for Living Inventory
timeFrame: 3 months
measure: Changes in State Hope Scale
timeFrame: 3 months
measure: Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness.
timeFrame: 3 months
measure: Changes in Beck Scale for Suicide Ideation
timeFrame: 3 months
measure: Suicide Attempt Self-Injury Count
timeFrame: 3 months
Secondary outcomes:
measure: Outpatient Health Services Engagement
timeFrame: 12 months
measure: Acute Care Health Services
timeFrame: 12 months
measure: Self-Directed Violence
timeFrame: 12 months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Robley Rex VA Medical Center
state: Kentucky
Study officials:
affiliation: Robley Rex VA Medical Center
name: Stephen O'Connor, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.