NCT03600532

Brief Summary

This study is looking at the helpfulness of a brief treatment targeting suicidality (Teachable Moment Brief Intervention \[TMBI\]) and experimental pain responses in an inpatient population as well as collecting comparison data from the community.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Geographic Reach
1 country

2 active sites

Status
terminated

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

July 1, 2018

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2018

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 26, 2018

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

August 14, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

July 3, 2018

Last Update Submit

August 12, 2019

Conditions

Keywords

experimental pain

Outcome Measures

Primary Outcomes (1)

  • 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).

    Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

Secondary Outcomes (10)

  • Changes in Stages of Change Questionnaire

    Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

  • Changes in Reasons for Living Inventory

    Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

  • Changes in Adult State Hope Scale

    Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

  • Change in Positive and Negative Affect Schedule

    Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

  • Changes in Ischemic Pain Outcomes

    Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

  • +5 more secondary outcomes

Study Arms (3)

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 (TMBI)

Treatment as Usual (TAU)

NO INTERVENTION

Usual care at Laureate Psychiatric Clinic and Hospital Adult Stabilization Unit who have attempted suicide involves psychiatric evaluation/treatment and ongoing medical stabilization. Patients will engage in usual care or a rest period before completing the post-assessment.

Community Control Group (CCG)

NO INTERVENTION

Patients will engage in a rest period before completing the post-assessment.

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 VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • admitted to LPCH subsequent to a suicide attempt

You may not qualify if:

  • acute psychosis,
  • inability to read English, or
  • taking narcotic or opioid pain medication
  • CCG (data collection in the Psychophysiology Laboratory for Affective Neuroscience \[PLAN\] on the University of Tulsa campus)
  • acute psychosis,
  • current suicide ideation,
  • history of self-harm,
  • inability to read English, or
  • taking narcotic or opioid pain medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Tulsa, Psychophysiology Laboratory for Affective Neuroscience (PLAN)

Tulsa, Oklahoma, 74104, United States

Location

Laureate Psychiatric Clinic and Hospital

Tulsa, Oklahoma, 74136, 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

  • Cassandra A Sturycz, MA

    University of Tulsa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants will be assigned in even numbers to TMBI \& TAU or recruited as part of a CCG
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 3, 2018

First Posted

July 26, 2018

Study Start

July 1, 2018

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

August 14, 2019

Record last verified: 2019-08

Locations