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

Suicide, Attempted Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03600532
• Other study ID #: TU1808
• Status: Terminated
• Phase: N/A
• Start date: July 1, 2018
• Est. completion date: July 1, 2019

Study information

• Verified date: August 2019
• Source: University of Tulsa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: July 1, 2019
• Est. primary completion date: July 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Suicide
• Suicide, Attempted

Intervention

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.

Locations

Country	Name	City	State
United States	Laureate Psychiatric Clinic and Hospital	Tulsa	Oklahoma
United States	University of Tulsa, Psychophysiology Laboratory for Affective Neuroscience (PLAN)	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Tulsa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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).	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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).	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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.	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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).	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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).	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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).	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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.	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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.	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)
Secondary	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.	Assessed immediately before the intervention or rest period (baseline) and immediately after the intervention or rest period (approximately 1 hour from baseline)