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

Primary Purpose

Suicide, Attempted

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Teachable Moment Brief Intervention (TMBI)
Sponsored by
University of Tulsa
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring experimental pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Tulsa, Psychophysiology Laboratory for Affective Neuroscience (PLAN)
  • Laureate Psychiatric Clinic and Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Teachable Moment Brief Intervention

Treatment as Usual (TAU)

Community Control Group (CCG)

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Changes in Stages of Change Questionnaire
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.
Changes in Reasons for Living Inventory
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).
Changes in Adult State Hope Scale
6-item measure of ongoing self-directed thinking. Total score will be reported, which ranges from 6 (low hope) to 48 (high hope).
Change in Positive and Negative Affect Schedule
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.
Changes in Ischemic Pain Outcomes
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).
Changes in Mechanical Pressure Pain Outcomes
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).
Changes in Temporal Summation of Pain
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).
Changes in Skin Conductance Level
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.
Changes in Blood Pressure
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.
Changes in Cardiovascular Measurements
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.

Full Information

First Posted
July 3, 2018
Last Updated
August 12, 2019
Sponsor
University of Tulsa
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1. Study Identification

Unique Protocol Identification Number
NCT03600532
Brief Title
Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting
Acronym
TMBI-IP
Official Title
Testing the Efficacy of the Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting: Effects on Psychosocial and Experimental Pain Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Due to lack of participant recruitment
Study Start Date
July 1, 2018 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Tulsa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
experimental pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be assigned in even numbers to TMBI & TAU or recruited as part of a CCG
Masking
None (Open Label)
Allocation
Randomized
Enrollment
7 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teachable Moment Brief Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Treatment as Usual (TAU)
Arm Type
No Intervention
Arm Description
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.
Arm Title
Community Control Group (CCG)
Arm Type
No Intervention
Arm Description
Patients will engage in a rest period before completing the post-assessment.
Intervention Type
Behavioral
Intervention Name(s)
Teachable Moment Brief Intervention (TMBI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Beck Scale for Suicide Ideation
Description
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).
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary Outcome Measure Information:
Title
Changes in Stages of Change Questionnaire
Description
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.
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Changes in Reasons for Living Inventory
Description
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).
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Changes in Adult State Hope Scale
Description
6-item measure of ongoing self-directed thinking. Total score will be reported, which ranges from 6 (low hope) to 48 (high hope).
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Change in Positive and Negative Affect Schedule
Description
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.
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Changes in Ischemic Pain Outcomes
Description
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).
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Changes in Mechanical Pressure Pain Outcomes
Description
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).
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Changes in Temporal Summation of Pain
Description
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).
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Changes in Skin Conductance Level
Description
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.
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Changes in Blood Pressure
Description
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.
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Title
Changes in Cardiovascular Measurements
Description
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.
Time Frame
Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cassandra A Sturycz, MA
Organizational Affiliation
University of Tulsa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tulsa, Psychophysiology Laboratory for Affective Neuroscience (PLAN)
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Facility Name
Laureate Psychiatric Clinic and Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
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

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Teachable Moment Brief Intervention for Suicide Attempt Survivors in an Inpatient Setting

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