Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting (TMBI-IP)

August 12, 2019 updated by: University of Tulsa

Testing the Efficacy of the Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting: Effects on Psychosocial and Experimental Pain Outcomes

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed study will use an innovative one-session psychotherapeutic intervention called the Teachable Moment Brief Intervention (TMBI) for suicide attempters admitted to a psychiatric inpatient unit. A total of 60 patients will be recruited from the inpatient psychiatry unit at Laureate Psychiatric Clinic and Hospital and 30 healthy community members for the study. Informed consent will be obtained for all participants and administration of the baseline assessment battery will be completed prior to randomization for patients. Patients will then be randomized to either (a) an experimental group receiving TMBI or (b) a group receiving treatment as usual (TAU). 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. All participants will complete a follow-up assessment immediately following TMBI, TAU, or a rest period. Further, patients receiving the experimental intervention will then be asked to complete a client satisfaction survey. The aim will be to assess whether TMBI affects psychological, experimental pain, and autonomic nervous system responses as compared to TAU and community controls.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
7

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74136
        • Laureate Psychiatric Clinic and Hospital
      • Tulsa, Oklahoma, United States, 74104
        • University of Tulsa, Psychophysiology Laboratory for Affective Neuroscience (PLAN)

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

TMBI & TAU (data collection at Laureate Psychiatric Clinic and Hospital [LPCH])

Inclusion:

-admitted to LPCH subsequent to a suicide attempt

Exclusion:

  • 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)

Exclusion:

  • acute psychosis,
  • current suicide ideation,
  • history of self-harm,
  • inability to read English, or
  • taking narcotic or opioid pain medication

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
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: 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.
Behavioral: Teachable Moment Brief Intervention (TMBI)
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.
NO_INTERVENTION: Treatment as Usual (TAU)
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.
NO_INTERVENTION: Community Control Group (CCG)
Patients will engage in a rest period before completing the post-assessment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Beck Scale for Suicide Ideation
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Stages of Change Questionnaire
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
18-item measure that measures motivation to engage in treatment/work on problems. Total score will be summed from all items, with range from 18 (low motivation) to 90 (high motivation). Four subscales will also be reported as follows: Precontemplation ranges from 5 (low) to 25 (high) with higher scores indicating higher motivation. Contemplation ranges from 4 (low) to 20 (high) with higher scores indicating higher motivation. Action ranges from 5 (low) to 25 (high) with higher scores indicating higher motivation. Maintenance ranges from 4 (low) to 20 (high) with higher scores indicating higher motivation.
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
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
48-item measure that rates the importance of different reasons why people choose not to kill themselves. Total score will be reported, which ranges from 48 (low reasons for living) to 288 (High reasons for living).
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
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
6-item measure of ongoing self-directed thinking. Total score will be reported, which ranges from 6 (low hope) to 48 (high hope).
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
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
20-item self-report measure of Positive (PANAS-PA; 10 items) and Negative (PANAS-NA; 10 items) Affect. Each PANAS emotion word is rated on a 5-point scale, 1 (very slightly) to 5 (extremely) corresponding to the extent to which each emotion is experienced at the time of administration. Thus, higher scores indicate more and/or stronger positive (PANAS-PA) or negative (PANAS-NA) emotions.
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
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Ischemia produces a pain akin to clinical musculoskeletal pain syndromes. 120 handgrip exercises will be conducted at a rate of 1/sec at 50% maximal effort using a dynamometer (handgrip force meter), and then the arm will be raised to promote exsanguination. A blood pressure cuff will then be inflated around the arm biceps to 220 mm/Hg to produce ischemia. The participants will be instructed to inform the experimenter when they first experience pain (pain threshold). The cuff will be deflated when the pain is no longer tolerable or after 3 minutes (pain tolerance). After 3 minutes as measured by a stopwatch (or when the participant discontinues the task), they will be asked to rate the average and peak pain intensity during the task on a scale from 0 (no pain) to 100 (intolerable pain).
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Changes in Mechanical Pressure Pain Outcomes
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Delivered using von Frey hairs (i.e., monofilament = brush with only one bristle) on the back of the nondominant hand. The monofilament, sized 6.45, will be applied to the skin at a 90 degree angle, which exerts 180 grams of force. The participant will be asked to rate their pain on a scale of 0 (no pain) to 100 (intolerable pain).
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Changes in Temporal Summation of Pain
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Delivered using von Frey hairs (i.e., monofilament = brush with only one bristle) on the back of the nondominant hand. The 6.45 monofilament will be applied to the skin at a 90 degree angle 10 times, once per second. The participant will be asked to rate their peak pain during these 10 stimuli on a scale of 0 (no pain) to 100 (intolerable pain). Temporal summation is the extent by which pain experience increases over the course of repeated stimulus presentation. Therefore, it will be measured as the difference between the peak pain over the course of these 10 stimuli and the rating of the single stimulus (mechanical pressure pain).
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Changes in Skin Conductance Level
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Sympathetic arousal will be measured from skin conductance level (SCL), measured from a BioDerm meter (UFI Model 2701) and corresponding electrodes filled with isotonic paste and placed on the volar surface of the medial digit on the index and middle fingers of the left hand. SCL will be assessed during the resting BP measurement prior to any testing, for one minute prior to pain testing during the BP measurement, during pain testing, and for one minute following pain testing during the second BP measurement. SCL will be recorded every 15 seconds manually by the experimenter. A pain-related change score will be created to find the difference between the average SCL during baseline and during pain testing. A recovery-related change score will be created to find the difference between average SCL during pain testing and the average post pain testing SCL.
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Changes in Blood Pressure
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Resting systolic and diastolic blood pressure (BP) will be measured using a medical blood pressure monitor prior to testing. BP will also be measured just prior to and immediately following the pain testing. BP will be measured on the right arm. A pain-related change score will be created to find the difference between the BP before and after pain testing.
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Changes in Cardiovascular Measurements
Time Frame: Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Resting heart rate (HR; e.g., beats per minute [BPM]) will be measured using a medical blood pressure monitor prior to testing. HR will also be measured just prior to and immediately following the pain testing. HR will be measured on the right arm. A pain-related change score will be created to find the difference between the HR before and after pain testing.
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Tulsa

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Cassandra A Sturycz, MA, University of Tulsa

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

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 (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 3, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 14, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 12, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TU1808

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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