- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02414763
Pilot Study of a Brief Intervention for Medically Hospitalized Suicide Attempt Survivors
May 2, 2018 updated by: Western Kentucky University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
69
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232
- Vanderbilt University Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Care as Usual
Participants will receive usual care services provided to suicide attempt survivors, including inpatient psychiatry, outpatient psychotherapy, and case management.
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Experimental: Teachable Moment Brief Intervention
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.
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functional analysis, collaborative interpersonal style
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Client Satisfaction Questionnaire
Time Frame: Immediately following Brief Intervention
|
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.
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Immediately following Brief Intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Stages of Change Questionnaire
Time Frame: Baseline, 1-, 3-, and 12-months interviews
|
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.
|
Baseline, 1-, 3-, and 12-months interviews
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Change in Scale for Suicide Ideation
Time Frame: Baseline, 1-, 3-, and 12-months interviews
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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
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Baseline, 1-, 3-, and 12-months interviews
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|
Change in Suicide Attempt Self-Injury Count
Time Frame: Baseline, 1-, 3-, and 12-months interviews
|
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.
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Baseline, 1-, 3-, and 12-months interviews
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Change in Interpersonal Needs Questionnaire
Time Frame: Baseline, 1-, 3-, and 12-months interviews
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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
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Baseline, 1-, 3-, and 12-months interviews
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Change in Reasons for Living Inventory
Time Frame: Baseline, 1-, 3-, and 12-months interviews
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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
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Baseline, 1-, 3-, and 12-months interviews
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Change in Health Services and Medication Use
Time Frame: 1-, 3-, and 12-months interviews
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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.
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1-, 3-, and 12-months interviews
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Stephen S O'Connor, Ph.D., Western Kentucky University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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:CD013668. doi: 10.1002/14651858.CD013668.pub2.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2014
Primary Completion (Actual)
June 14, 2017
Study Completion (Actual)
June 14, 2017
Study Registration Dates
First Submitted
December 16, 2014
First Submitted That Met QC Criteria
April 7, 2015
First Posted (Estimate)
April 13, 2015
Study Record Updates
Last Update Posted (Actual)
May 3, 2018
Last Update Submitted That Met QC Criteria
May 2, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 131757
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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