Suicide, AttemptedNCT03533075
Teachable Moment Brief Intervention for Veterans Following a Suicide Attempt
A study testing Teachable Moment Brief Intervention in people with Suicide, Attempted, run by Louisville VA Medical Center at 1 site in United States.
Trial summary
The overall objective is to determine the acceptability and feasibility of the Teachable Moment Brief Intervention (TMBI) + follow-up consultation for Veterans treated on an inpatient psychiatry unit following a suicide attempt. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Teachable Moment Brief Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Apr 2018to 30 Aug 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Veteran service member
- Recently admitted to an inpatient psychiatry unit at the VAMC site following a suicide attempt
- 18 or more years of age
- Consents to participate in baseline and follow-up interviews and gives permission to review records for previous year and subsequent year.
- Consents to randomization and participation in TMBI + follow-up or Care as Usual
- Consents to audio recording in order for PI to conduct adherence rating
Who cannot join
- Significant psychosis, cognitive, or other problems that prevent participant from understanding the study procedures or renders them unable to provide informed consent (suggesting that psychosocial therapeutic care is contra-indicated)
- Judicially-ordered to treatment (e.g., subsequent to domestic violence) such that participation in study procedures could not be considered voluntary and participant is not free to drop out without significant negative consequences.
Trial locations and contacts
1 site in 1 country.
United States1 site
Robley Rex VA Medical Center
Louisville, Kentucky, 40206-1433
About this study
Official title: A Pilot Effectiveness Trial of the Teachable Moment Brief Intervention (TMBI) for Veterans Hospitalized Following a Suicide Attempt
The overall objective is to determine the acceptability and feasibility of the Teachable Moment Brief Intervention (TMBI) + follow-up consultation for Veterans treated on an inpatient psychiatry unit following a suicide attempt. The study will also determine whether there is a signal of effectiveness supporting the TMBI in improving the recovery trajectory of Veterans following discharge to the community.
Read the detailed description
A total of 50 patients will be recruited from the inpatient psychiatry unit for the study. A member from the research team will obtain informed consent for the participants and then administer the baseline assessment battery. Patients will then be randomized to either (a) an experimental group receiving TMBI + follow-up consultation or (b) a group receiving care as usual. Patients randomized to the experimental group will receive the intervention prior to discharge from the hospital, most likely on the same day as the baseline assessment battery. Patients receiving the experimental intervention will then be asked to complete a brief post-intervention client satisfaction survey administered by a research team member. All study participants will then complete telephone follow-up assessments at 1 and 3-month time points administered by members of the research team and supervised by the PI. Additionally, patient electronic medical records will be abstracted to document the following health services and clinical characteristics in the 12 months following enrollment in the study: death for any reason, inpatient hospitalization (both medical/surgical and psychiatric), emergency department visits, suicide attempt and other forms of self-directed violence, all outpatient appointments with VA service providers, and diagnosis. The PI will rate the TMBI sessions for the interventionists. When the PI delivers the intervention, a trained member of the research team will review the PI's sessions and rate for adherence. 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. The baseline assessment battery will take approximately 30 minutes, the post-intervention measure will take approximately 5 minutes, and the 1 and 3-month assessment batteries will take approximately 30 minutes. The PI and potentially 2 to 3 members of the Suicide Prevention Program will provide the intervention to ~25 randomized patients.
Notes will be kept on patients who decided to drop out of the intervention and/or the study. We will examine the mean and standard deviation for the total score and individual items on the Client Satisfaction Questionnaire. Notes will be kept documenting all contacts for recruitment and the number of eligible patients per month. Reasons for inclusion and exclusion of potential participants will be documented as well as reasons participants give for choosing not to participate. Number of patients enrolled and randomized each month will be documented. Notes will be kept of rates of on-time outcome assessments and days late and any assessments missed or participants lost to contact.
Descriptive statistics for demographic and clinical variables will be tabulated. All scales will be scored and subscales described. This process will include examining the data for missing values, appropriate ranges, and outliers. Although the randomization design should ensure balance between the two groups, it is essential to control for any known confounders in the design and analysis to prevent a biased assessment of the brief intervention effect. Any baseline demographic or clinical variables found to be statistically significant in the analysis will be included as covariates in all analytic models. We will use an intent-to-treat sample to complete our analyses. We will utilize mixed-effects regression models to obtain between-groups effect sizes for the impact of the TMBI + consultation on elevating motivation, hope, reasons for living and social connection.
- Conditions
- Suicide, Attempted
- Being tested
- Teachable Moment Brief Intervention
- 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 InterventionBehavioural
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Teachable Moment Brief Intervention |
| Care as Usual | No intervention | Usual care at Veterans Affairs Medical Centers (VAMC) for Veterans who have attempted suicide involves psychiatric evaluation/treatment and ongoing medical stabilization. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Stages of Change Questionnaire, which measures motivation
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: 3 months
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: 3 months
Changes in 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: 3 months
Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness.
15-item measure of the extent to which individuals feel connected to others (i.e., belongingness) and like a burden on people in their lives (i.e., perceived burdensomeness). Subscale total scores for thwarted belongingness and perceived burdensomeness will be reported. For thwarted belongingness, scores range from 9 (low) to 63 (high). For perceived burdensomeness, scores range from 6 (low) to 42 (high).
Measured: 3 months
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: 3 months
Suicide Attempt Self-Injury Count
two-page instrument determining for the first, most recent, and most severe suicide attempt or non-suicidal self-injury (SASI) the date, method of SASI attempt used in index and previous attempts according to the definitions of Linehan et al. (e.g., using definitions of self-inflicted injuries which include situations of actual tissue damage and situations where tissue damage would have occurred except for outside intervention or sheer luck [e.g., firearm jammed]), intent to die (i.e., intent to die, ambivalent, no intent to die), highest level of medical treatment received, and lethality
Measured: 3 months
Secondary outcomes (3)
Outpatient Health Services Engagement
all outpatient appointments with VA service providers using electronic health record data
Measured: 12 months
Acute Care Health Services
inpatient hospitalization (both medical/surgical and psychiatric) and emergency department visits using electronic health record data
Measured: 12 months
Self-Directed Violence
All documented self-directed violence across 12 months using electronic health record data
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2018
- Study start23 Apr 2018
- Primary completion30 Aug 2020
- Study completion30 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 + follow-up consultation or care as usual.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Louisville VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Louisville
- Responsible party
- Principal investigator, Stephen O'Connor, Ph.D., Louisville VA Medical Center
- Investigators
- Stephen O'Connor, PhD, Principal investigator, Robley Rex VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03533075
- Sponsor's protocol ID
- 00466
- Status last verified
- Sep 2020
- First submitted
- 26 Apr 2018
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Effectiveness Trial of the Teachable Moment Brief Intervention (TMBI) for Veterans Hospitalized Following a Suicide Attempt
- ClinicalTrials.gov ID
- NCT03533075
- Acronym / sponsor ID
- 00466
- Conditions
- Suicide, Attempted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Louisville VA Medical CenterUS federal agency
- Collaborators
- University of Louisville
- Study start
- 23 Apr 2018 (actual)
- Primary completion
- 30 Aug 2020 (actual)
- Study completion
- 30 Aug 2020 (actual)
- First posted
- 22 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The overall objective is to determine the acceptability and feasibility of the Teachable Moment Brief Intervention (TMBI) + follow-up consultation for Veterans treated on an inpatient psychiatry unit following a suicide attempt. The study will also determine whether there is a signal of effectiveness supporting the TMBI in improving the recovery trajectory of Veterans following discharge to the community.
Detailed description
A total of 50 patients will be recruited from the inpatient psychiatry unit for the study. A member from the research team will obtain informed consent for the participants and then administer the baseline assessment battery. Patients will then be randomized to either (a) an experimental group receiving TMBI + follow-up consultation or (b) a group receiving care as usual. Patients randomized to the experimental group will receive the intervention prior to discharge from the hospital, most likely on the same day as the baseline assessment battery. Patients receiving the experimental intervention will then be asked to complete a brief post-intervention client satisfaction survey administered by a research team member. All study participants will then complete telephone follow-up assessments at 1 and 3-month time points administered by members of the research team and supervised by the PI. Additionally, patient electronic medical records will be abstracted to document the following health services and clinical characteristics in the 12 months following enrollment in the study: death for any reason, inpatient hospitalization (both medical/surgical and psychiatric), emergency department visits, suicide attempt and other forms of self-directed violence, all outpatient appointments with VA service providers, and diagnosis. The PI will rate the TMBI sessions for the interventionists. When the PI delivers the intervention, a trained member of the research team will review the PI's sessions and rate for adherence. 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. The baseline assessment battery will take approximately 30 minutes, the post-intervention measure will take approximately 5 minutes, and the 1 and 3-month assessment batteries will take approximately 30 minutes. The PI and potentially 2 to 3 members of the Suicide Prevention Program will provide the intervention to ~25 randomized patients.
Notes will be kept on patients who decided to drop out of the intervention and/or the study. We will examine the mean and standard deviation for the total score and individual items on the Client Satisfaction Questionnaire. Notes will be kept documenting all contacts for recruitment and the number of eligible patients per month. Reasons for inclusion and exclusion of potential participants will be documented as well as reasons participants give for choosing not to participate. Number of patients enrolled and randomized each month will be documented. Notes will be kept of rates of on-time outcome assessments and days late and any assessments missed or participants lost to contact.
Descriptive statistics for demographic and clinical variables will be tabulated. All scales will be scored and subscales described. This process will include examining the data for missing values, appropriate ranges, and outliers. Although the randomization design should ensure balance between the two groups, it is essential to control for any known confounders in the design and analysis to prevent a biased assessment of the brief intervention effect. Any baseline demographic or clinical variables found to be statistically significant in the analysis will be included as covariates in all analytic models. We will use an intent-to-treat sample to complete our analyses. We will utilize mixed-effects regression models to obtain between-groups effect sizes for the impact of the TMBI + consultation on elevating motivation, hope, reasons for living and social connection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be assigned in even numbers to TMBI + follow-up consultation or care as usual.
| Arm | Type | Receives |
|---|---|---|
| Teachable Moment Brief Intervention | Experimental | Behavioral: Teachable Moment Brief InterventionThe 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. |
| Care as Usual | No intervention | –Usual care at Veterans Affairs Medical Centers (VAMC) for Veterans who have attempted suicide involves psychiatric evaluation/treatment and ongoing medical stabilization. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Veteran service member
- Recently admitted to an inpatient psychiatry unit at the VAMC site following a suicide attempt
- 18 or more years of age
- Consents to participate in baseline and follow-up interviews and gives permission to review records for previous year and subsequent year.
- Consents to randomization and participation in TMBI + follow-up or Care as Usual
Key exclusion criteria (2 listed)
- Significant psychosis, cognitive, or other problems that prevent participant from understanding the study procedures or renders them unable to provide informed consent (suggesting that psychosocial therapeutic care is contra-indicated)
- Judicially-ordered to treatment (e.g., subsequent to domestic violence) such that participation in study procedures could not be considered voluntary and participant is not free to drop out without significant negative consequences.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teachable Moment Brief InterventionBehavioral 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 | Behavioural | Teachable Moment Brief Intervention |
Primary outcome
Changes in Stages of Change Questionnaire, which measures motivation
Time frame: 3 months
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
Time frame: 3 months
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 State Hope Scale
Time frame: 3 months
6-item measure of ongoing self-directed thinking. Total score will be reported, which ranges from 6 (low hope) to 48 (high hope).
Changes in Interpersonal Needs Questionnaire, which measures constructs of thwarted belongingness and perceived burdensomeness.
Time frame: 3 months
15-item measure of the extent to which individuals feel connected to others (i.e., belongingness) and like a burden on people in their lives (i.e., perceived burdensomeness). Subscale total scores for thwarted belongingness and perceived burdensomeness will be reported. For thwarted belongingness, scores range from 9 (low) to 63 (high). For perceived burdensomeness, scores range from 6 (low) to 42 (high).
Changes in Beck Scale for Suicide Ideation
Time frame: 3 months
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)
Suicide Attempt Self-Injury Count
Time frame: 3 months
two-page instrument determining for the first, most recent, and most severe suicide attempt or non-suicidal self-injury (SASI) the date, method of SASI attempt used in index and previous attempts according to the definitions of Linehan et al. (e.g., using definitions of self-inflicted injuries which include situations of actual tissue damage and situations where tissue damage would have occurred except for outside intervention or sheer luck [e.g., firearm jammed]), intent to die (i.e., intent to die, ambivalent, no intent to die), highest level of medical treatment received, and lethality
3 secondary outcomes
Outpatient Health Services Engagement
Time frame: 12 months
Acute Care Health Services
Time frame: 12 months
Self-Directed Violence
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2020.
- Derived from this study: PubMed 33884617Witt 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen O'Connor, PhD principal investigator
Robley Rex VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teachable Moment Brief Intervention in people with Suicide, Attempted, run by Louisville VA Medical Center at 1 site 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 6 inclusion and 2 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: finished, as of the sponsor's last update on 11 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Stages of Change Questionnaire, which measures motivation (time frame: 3 months). The study lists 6 primary outcomes in all. 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 NCT03533075, 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 11 Sep 2020.