search
Back to results

Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors

Primary Purpose

Suicide Attempt

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Teachable Moment Brief Intervention
Sponsored by
Western Kentucky University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide Attempt

Eligibility Criteria

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

Inclusion Criteria:

  • 18 years of age and above
  • Inpatient on medical/surgical unit either currently or prior to transfer to inpatient psychiatric unit
  • Admitted following a suicide attempt
  • Sufficient English to benefit from psychotherapy in English
  • Consents to be a research participant

Exclusion Criteria:

  • Lack of sufficient English to participate in psychotherapy in English
  • Prisoner/inmate at time of admission
  • Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay in the medical center. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between discussions with research team members and the Adult Psychiatry Consultation Service Physician providing care to the patient, as well as the interventionist's own clinical assessment of the patient at the outset of the brief intervention.

Sites / Locations

  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Care as Usual

Teachable Moment Brief Intervention

Arm Description

Participants will receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management.

The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, functional analysis of the suicidal ideation and behaviors, and crisis response planning. Participants will also receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management.

Outcomes

Primary Outcome Measures

Client Satisfaction Questionnaire
The 8-item Client Satisfaction Questionnaire is a general measure of individual satisfaction with health and human services that takes 3-8 minutes to complete.

Secondary Outcome Measures

Change in Stages of Change Questionnaire
The Stages of Change Questionnaire is an 18-item measure based on the original, 32- item scale created by McConnaughy, Prochaska, and Verlicer. The measure has shown acceptable levels of internal consistency in an adult sample (α = .75 to .87) and predictive validity of response to treatment.
Change in Scale for Suicide Ideation
The Scale for Suicide Ideation is a 19-item assessment used to evaluate the current intensity of the patient's specific attitudes toward, behavior, and plans to commit suicide. The measure has been the primary outcome measure in several trials targeting suicidal patients and has evidence of strong psychometrics
Change in Suicide Attempt Self-Injury Count
The Suicide Attempt Self-Injury Count is a brief 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.
Change in Interpersonal Needs Questionnaire
The Interpersonal Needs Questionnaire is a 25-item measure that inquires about the extent to which individuals feel connected to others (i.e., belongingness) and the extent to which they feel like a burden on the people in their lives (i.e., perceived burdensomeness). The measure has been used in previous research examining mechanisms underlying suicide attempt survivors and has demonstrated acceptable psychometric properties
Change in Reasons for Living Inventory
The Reasons for Living Inventory is a 48-item measure that rates the importance of different reasons why people choose not to kill themselves. It has shown strong internal consistency and test-retest reliability
Change in Health Services and Medication Use
The Health Services and Medication Use measure will be utilized to examine history of mental health services and medication use in lifetime, previous year, and previous month time periods. The measure was developed and utilized in the National Study of Costs and Outcomes for Trauma.

Full Information

First Posted
December 16, 2014
Last Updated
May 2, 2018
Sponsor
Western Kentucky University
Collaborators
Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT02414763
Brief Title
Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors
Official Title
Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 14, 2017 (Actual)
Study Completion Date
June 14, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western Kentucky University
Collaborators
Vanderbilt University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The current study proposes to study the feasibility and acceptability of a brief psychosocial intervention delivered to suicide attempt survivors hospitalized on a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The proposed study will involve training of care providers affiliated with Vanderbilt University Medical Center to deliver the brief intervention. Additionally, the participants will complete baseline, 1, 3, and 12-month assessments on outcomes of interest, including readiness to change problematic behaviors, engagement in outpatient mental health services, suicidal ideation, self-harming behavior, and reasons for living.
Detailed Description
One-hundred participants will be recruited from a medical/surgical floor or inpatient psychiatry unit at Vanderbilt University Medical Center. The PI, other Attending Psychiatrists, Psychiatry Resident Physicians, Clinical Psychology Trainees, Psychiatric Nurse Practitioners, Psychiatric Social Workers, and Psychiatric Nurse Case Managers will serve as study therapists. A member from the Vanderbilt University research team will obtain informed consent for the participants and then administer the baseline assessment battery. Patients will then be randomized to either (1) a group receiving care as usual plus an experimental intervention targeting suicidal thoughts and behaviors or to (2) a group receiving care as usual. Patients randomized to the experimental group will receive the intervention prior to discharge from the medical center, 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. All study participants will then complete telephone follow-up assessments at 1, 3, and 12 months. The intervention will consist of no more than 90 minutes of 1:1 interaction with a study clinician. The baseline assessment battery will take approximately 30 minutes, the post-intervention measures will take approximately 10 minutes, and the 1-, 3-, and 12-month assessment batteries will take approximately 30 minutes. Maximum length of time in the study is approximately 3.75 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide Attempt

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
69 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care as Usual
Arm Type
No Intervention
Arm Description
Participants will receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management.
Arm Title
Teachable Moment Brief Intervention
Arm Type
Experimental
Arm Description
The brief intervention consists of engaging the patient in conversation regarding suicidal ambivalence (desire to live vs. desire to die), collaborative discovery of primary and secondary drivers of suicidality, functional analysis of the suicidal ideation and behaviors, and crisis response planning. Participants will also receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management.
Intervention Type
Behavioral
Intervention Name(s)
Teachable Moment Brief Intervention
Intervention Description
functional analysis, collaborative interpersonal style
Primary Outcome Measure Information:
Title
Client Satisfaction Questionnaire
Description
The 8-item Client Satisfaction Questionnaire is a general measure of individual satisfaction with health and human services that takes 3-8 minutes to complete.
Time Frame
Immediately following Brief Intervention
Secondary Outcome Measure Information:
Title
Change in Stages of Change Questionnaire
Description
The Stages of Change Questionnaire is an 18-item measure based on the original, 32- item scale created by McConnaughy, Prochaska, and Verlicer. The measure has shown acceptable levels of internal consistency in an adult sample (α = .75 to .87) and predictive validity of response to treatment.
Time Frame
Baseline, 1-, 3-, and 12-months interviews
Title
Change in Scale for Suicide Ideation
Description
The Scale for Suicide Ideation is a 19-item assessment used to evaluate the current intensity of the patient's specific attitudes toward, behavior, and plans to commit suicide. The measure has been the primary outcome measure in several trials targeting suicidal patients and has evidence of strong psychometrics
Time Frame
Baseline, 1-, 3-, and 12-months interviews
Title
Change in Suicide Attempt Self-Injury Count
Description
The Suicide Attempt Self-Injury Count is a brief 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.
Time Frame
Baseline, 1-, 3-, and 12-months interviews
Title
Change in Interpersonal Needs Questionnaire
Description
The Interpersonal Needs Questionnaire is a 25-item measure that inquires about the extent to which individuals feel connected to others (i.e., belongingness) and the extent to which they feel like a burden on the people in their lives (i.e., perceived burdensomeness). The measure has been used in previous research examining mechanisms underlying suicide attempt survivors and has demonstrated acceptable psychometric properties
Time Frame
Baseline, 1-, 3-, and 12-months interviews
Title
Change in Reasons for Living Inventory
Description
The Reasons for Living Inventory is a 48-item measure that rates the importance of different reasons why people choose not to kill themselves. It has shown strong internal consistency and test-retest reliability
Time Frame
Baseline, 1-, 3-, and 12-months interviews
Title
Change in Health Services and Medication Use
Description
The Health Services and Medication Use measure will be utilized to examine history of mental health services and medication use in lifetime, previous year, and previous month time periods. The measure was developed and utilized in the National Study of Costs and Outcomes for Trauma.
Time Frame
1-, 3-, and 12-months interviews

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age and above Inpatient on medical/surgical unit either currently or prior to transfer to inpatient psychiatric unit Admitted following a suicide attempt Sufficient English to benefit from psychotherapy in English Consents to be a research participant Exclusion Criteria: Lack of sufficient English to participate in psychotherapy in English Prisoner/inmate at time of admission Too cognitively impaired, delirious, or psychotic to respond to psychotherapeutic intervention before end of stay in the medical center. Determination of cognitive impairment, delirium, agitation, and psychosis will be determined through the referral phone call between discussions with research team members and the Adult Psychiatry Consultation Service Physician providing care to the patient, as well as the interventionist's own clinical assessment of the patient at the outset of the brief intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen S O'Connor, Ph.D.
Organizational Affiliation
Western Kentucky University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33884617
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.
Results Reference
derived
PubMed Identifier
30389316
Citation
O'Connor SS, Mcclay MM, Choudhry S, Shields AD, Carlson R, Alonso Y, Lavin K, Venanzi L, Comtois KA, Wilson JE, Nicolson SE. Pilot randomized clinical trial of the Teachable Moment Brief Intervention for hospitalized suicide attempt survivors. Gen Hosp Psychiatry. 2020 Mar-Apr;63:111-118. doi: 10.1016/j.genhosppsych.2018.08.001. Epub 2018 Aug 10.
Results Reference
derived

Learn more about this trial

Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors

We'll reach out to this number within 24 hrs