Teachable Moment Brief Intervention for Veterans Following a Suicide Attempt

NCT ID: NCT03533075

Last Updated: 2020-09-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-23
• Study Completion Date: 2020-08-30

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.

Conditions

Suicide, Attempted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Teachable Moment Brief Intervention

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.

Group Type: EXPERIMENTAL

Teachable Moment Brief Intervention

Intervention Type: BEHAVIORAL

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

Care as Usual

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Teachable Moment Brief Intervention

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Louisville

OTHER

Sponsor Role: collaborator

Louisville VA Medical Center

FED

Sponsor Role: lead

Responsible Party

Stephen O'Connor, Ph.D.

Research Facilitator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Stephen O'Connor, PhD

Role: PRINCIPAL_INVESTIGATOR

Robley Rex VA Medical Center

Locations

Robley Rex VA Medical Center

Louisville, Kentucky, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33884617 (View on PubMed)

Other Identifiers

00466

Identifier Type: -

Identifier Source: org_study_id