AzTrials
AzTrials

Suicide, AttemptedTMBI-IPNCT03600532

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

A study testing Teachable Moment Brief Intervention (TMBI) in people with Suicide, Attempted, run by University of Tulsa at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Suicide, Attempted
What is being tested?
Teachable Moment Brief Intervention (TMBI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7 participants
Where
2 sitesUnited States
Study dates
1 Jul 2018to 1 Jul 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • -admitted to LPCH subsequent to a suicide attempt

Who cannot join

  • 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,
Show all 9Show fewer
  • history of self-harm,
  • inability to read English, or
  • taking narcotic or opioid pain medication

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • University of Tulsa, Psychophysiology Laboratory for Affective Neuroscience (PLAN)

    Tulsa, Oklahoma, 74104

  • Laureate Psychiatric Clinic and Hospital

    Tulsa, Oklahoma, 74136

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
Teachable Moment Brief Intervention (TMBI)
Keywords
experimental pain
Medical subject headings
Suicide, Attempted

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Teachable Moment Brief Intervention (TMBI)Behavioural

    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.

Study groups in NCT03600532
Study groupRoleWhat they receive
Teachable Moment Brief InterventionExperimentalThe 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.
Receives: Behavioral: Teachable Moment Brief Intervention (TMBI)
Treatment as Usual (TAU)No interventionUsual 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 interventionPatients will engage in a rest period before completing the post-assessment.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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)
  1. 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.

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

  2. 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).

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

  3. 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).

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

  4. 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.

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

  5. 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).

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

  6. 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).

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

  7. 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).

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

  8. 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.

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

  9. 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.

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

  10. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2018
  2. Study start1 Jul 2018
  3. Primary completion1 Jul 2019
  4. Study completion1 Jul 2019

Why it stopped: Due to lack of participant recruitment

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be assigned in even numbers to TMBI \& TAU or recruited as part of a CCG
Masking
None (open label)
Enrolment
7 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03600532
Sponsor's protocol ID
TU1808
Acronym
TMBI-IP
Status last verified
Aug 2019
First submitted
3 Jul 2018
Last updated
14 Aug 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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(4):CD013668. doi: 10.1002/14651858.CD013668.pub2.

    PubMed 33884617

Questions about this trial

What is this clinical trial studying?

A study testing Teachable Moment Brief Intervention (TMBI) in people with Suicide, Attempted, run by University of Tulsa at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Due to lack of participant recruitment). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03600532, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2019.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in