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Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Suicide | Device: Transcranial Magnetic Stimulation Other: Brief Cognitive Behavioral Therapy | Phase 2 Phase 3 |
The goal of the proposed study is to test the effect of adding Transcranial Magnetic Stimulation (TMS) to Brief Cognitive Behavioral Therapy (BCBT) to reduce Veterans' rates of suicide ideation and related behaviors. Over 20 Veterans die each day of suicide and rates have not appreciably decreased in the last ten years.
BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems. However, not all patients respond to BCBT. Thus finding ways to enhance treatment efficacy for reducing suicide is critical. Transcranial Magnetic Stimulation (TMS) may be an optimal treatment to use in conjunction with psychotherapy. TMS is a noninvasive technique that uses a pulsed magnetic field to induce neuronal depolarization in a targeted brain region, typically the left dorsolateral prefrontal cortex. TMS can reduce psychiatric symptoms associated with suicide risk in Veterans, including depression and PTSD. Furthermore, TMS is not associated with the systemic and costly side effects associated with medications used for these disorders (e.g., weight gain, diabetes, sexual side effects).
The primary objective of this study is to conduct a fully-powered randomized controlled trial evaluating the effect of adding a standard TMS course of treatment to BCBT to reduce suicide behaviors in a sample of Veterans hospitalized for suicide behavior. One hundred and thirty (130) Veterans admitted to the psychiatric unit for suicide ideation or attempts will be randomly assigned to either active TMS plus BCBT or to sham TMS plus BCBT. Participants will be assessed at baseline, post treatment, six, and 12 months post hospital discharge. Efficacy of the program will be determined by examining a primary suicide composite outcome and several secondary outcomes including suicide attempt, time to first attempt, number of re-hospitalizations and severity and severity of suicidal ideation. Secondary analyses will be conducted to help identify the types of patients who will receive the most benefit from the addition of TMS to BCBT Brief Cognitive Behavioral Therapy for suicide.
If successful, this study would result in a combined treatment to decrease suicide ideation and related behaviors. The proposal addresses HSRD post-deployment health priority, specifically suicide prevention and is innovative in that it will be the first study to examine efficacy of combined treatment specifically for suicide prevention.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 130 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | 130 Veterans admitted to the Providence VAMC psychiatric inpatient unit due to suicide attempt or ideation with intent to make an attempt will be recruited and randomly assigned to receive: a) active TMS+BCBT or b) sham TMS+BCBT. Both interventions will begin within the week following hospital discharge, and Veterans will be followed for 12 months post-discharge. |
| Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
| Masking Description: | Prior to each TMS session, un-blinded study staff will attach the appropriate (i.e., active or sham) coil according to the participants' randomization code (obtained from the urn randomization computer program). This will facilitate "triple blind" stimulation, where the participant, TMS provider, and outcome rater are blind to group assignation. |
| Primary Purpose: | Treatment |
| Official Title: | Combined Transcranial Magnetic Stimulation and Brief Cognitive Therapy to Reduce Suicide Behavior in High-Risk Veterans |
| Actual Study Start Date : | November 4, 2019 |
| Estimated Primary Completion Date : | March 31, 2023 |
| Estimated Study Completion Date : | March 31, 2023 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: TMS + Brief Cognitive Behavioral Therapy
Combined transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide
|
Device: Transcranial Magnetic Stimulation
Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex.
Other Name: TMS
Other: Brief Cognitive Behavioral Therapy BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems.
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Sham Comparator: Sham TMS + Brief cognitive behavioral therapy
Sham Transcranial magnetic stimulation and brief cognitive behavioral therapy for suicide
|
Device: Transcranial Magnetic Stimulation
Administration of rapidly fluctuating magnetic field, delivered over the dorsolateral prefrontal cortex.
Other Name: TMS
Other: Brief Cognitive Behavioral Therapy BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems.
|
- Change in Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 12 month follow up ]Interview administered assessment of suicide ideation and behavior. The interview consists of two subscales, an ideation and behavior subscale. The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
- Change in Beck Scale for Suicide Ideation (SSI) [ Time Frame: 12 month follow up ]
A 21-item interview administered measure. The first 5 items are screeners (wish to live, wish to die, and desire to attempt suicide), followed by 14 items to assess suicidal risk factors. The last 2 items capture previous suicide attempts.
Each item is rated on a 3-point scale ranging from 0 to 2 according to suicidal intensity. The SSI is scored by adding up the ratings (0-2) from the first 19 items.
- Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: 12 month follow up ]The WHODAS 2.0 is a 12-question, self-administered questionnaire and generic assessment instrument for health and disability that covers six domains: Cognition (items 3 and 6), Mobility (items 1 and 7), Self-care (items 8 and 9), Getting Along (items 10 and 11), Life Activities (items 2 and 12), and Participation (items 4 and 5). Items are rated from "None," "Mild," "Moderate," "Severe," to "Extreme or cannot do," indicating difficulty over the past month.
- Change in Treatment History Questionnaire [ Time Frame: 12 month follow up ]Interview based assessment of treatment use including hospitalizations, outpatient treatment, medication use, and emergency services. Participants report the number and type of outpatient, inpatient, residential, and emergency/crisis treatment received since last visit.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
-Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS.
Exclusion Criteria:
- Primary psychotic disorder
- Bipolar disorder
- Cognitive impairment which would interfere with adequate participation in the project (MMSE < 20).
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For safety, participants must meet established screening criteria safety during MRI, which is implemented as a conservative measure given the application of TMS in this population, since MRI involves magnetic fields at similar intensity to those emitted from the stimulation coil. These measures require a patient not having the following (unless MRI-safe):
- Cardiac pacemaker
- Implanted device (deep brain stimulation) or metal in the brain, cervical spinal cord, or upper thoracic spinal cord.
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TMS-specific exclusions are:
- pregnancy/lactation, or planning to become pregnant during the study
- lifetime history of moderate or severe traumatic brain injury (TBI)
- Current unstable medical conditions
- Current (or past if appropriate) significant neurological disorder
- Lifetime history seizure disorder
- Primary or secondary CNS tumors
- Stroke
- Cerebral aneurysm.
- Other exclusions are conditions that would like to be worsened by TMS, such as bipolar disorder
- Place Veterans at greater risk of seizures from TMS, such as severe and uncontrolled substance use disorder
- Inability to participate in CBT
- Other conditions or circumstance that, in the opinion of the investigator team, has the potential to prevent study completion and/or to have a confounding effect on outcome assessments
| Contact: Jennifer M Primack, PhD MA | (401) 273-7100 ext 13400 | Jennifer.Primack@va.gov | |
| Contact: Noah S Philip, MD | (401) 273-7100 ext 6200 | noah.philip@va.gov |
| United States, Rhode Island | |
| Providence VA Medical Center, Providence, RI | Recruiting |
| Providence, Rhode Island, United States, 02908 | |
| Contact: Candace M Shuman (401) 273-7100 ext 13872 Candace.Shuman@va.gov | |
| Contact: Debra D'Allesandro, BA (401) 273-7100 ext 6238 Debra.D'Allesandro@va.gov | |
| Principal Investigator: Jennifer Marie Primack, PhD MA | |
| Principal Investigator: | Jennifer Marie Primack, PhD MA | Providence VA Medical Center, Providence, RI |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 3, 2019 | ||||||||
| First Posted Date ICMJE | May 16, 2019 | ||||||||
| Last Update Posted Date | February 21, 2021 | ||||||||
| Actual Study Start Date ICMJE | November 4, 2019 | ||||||||
| Estimated Primary Completion Date | March 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Change in Columbia Suicide Severity Rating Scale (CSSRS) [ Time Frame: 12 month follow up ] Interview administered assessment of suicide ideation and behavior. The interview consists of two subscales, an ideation and behavior subscale. The severity of ideation subscale is rated on a 5-point ordinal scale: 1 = wish to be dead, 2 = nonspecific active suicidal thoughts, 3 = suicidal thoughts with methods, 4 = suicidal intent, and 5 = suicidal intent with plan. The suicidal behavior subscale is rated on a nominal scale that includes actual, aborted, and interrupted attempts; preparatory behavior; and nonsuicidal self-injurious behavior.
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide | ||||||||
| Official Title ICMJE | Combined Transcranial Magnetic Stimulation and Brief Cognitive Therapy to Reduce Suicide Behavior in High-Risk Veterans | ||||||||
| Brief Summary | High rates of Veteran suicide remain a tragedy. Rates of Veteran suicide have not decreased for 10 years, despite the best efforts of the field. Those interventions that do exist have only modest effects, which are simply insufficient for the magnitude of the problem. This proposal will combine two treatments - brief cognitive behavioral therapy (BCBT) and repetitive transcranial magnetic stimulation (TMS). Both of these interventions can reduce suicide and are available at Veterans Affairs Medical Centers across the country, yet to date no one has combined these therapies. This proposal will test the effect of this combination, and, if successful, will lead to a novel yet implementable new treatment to reduce Veteran suicide. | ||||||||
| Detailed Description |
The goal of the proposed study is to test the effect of adding Transcranial Magnetic Stimulation (TMS) to Brief Cognitive Behavioral Therapy (BCBT) to reduce Veterans' rates of suicide ideation and related behaviors. Over 20 Veterans die each day of suicide and rates have not appreciably decreased in the last ten years. BCBT is a well-established and efficacious treatment that is an extension of Cognitive Behavioral Therapy, a treatment that is widely implemented across VA health care systems. However, not all patients respond to BCBT. Thus finding ways to enhance treatment efficacy for reducing suicide is critical. Transcranial Magnetic Stimulation (TMS) may be an optimal treatment to use in conjunction with psychotherapy. TMS is a noninvasive technique that uses a pulsed magnetic field to induce neuronal depolarization in a targeted brain region, typically the left dorsolateral prefrontal cortex. TMS can reduce psychiatric symptoms associated with suicide risk in Veterans, including depression and PTSD. Furthermore, TMS is not associated with the systemic and costly side effects associated with medications used for these disorders (e.g., weight gain, diabetes, sexual side effects). The primary objective of this study is to conduct a fully-powered randomized controlled trial evaluating the effect of adding a standard TMS course of treatment to BCBT to reduce suicide behaviors in a sample of Veterans hospitalized for suicide behavior. One hundred and thirty (130) Veterans admitted to the psychiatric unit for suicide ideation or attempts will be randomly assigned to either active TMS plus BCBT or to sham TMS plus BCBT. Participants will be assessed at baseline, post treatment, six, and 12 months post hospital discharge. Efficacy of the program will be determined by examining a primary suicide composite outcome and several secondary outcomes including suicide attempt, time to first attempt, number of re-hospitalizations and severity and severity of suicidal ideation. Secondary analyses will be conducted to help identify the types of patients who will receive the most benefit from the addition of TMS to BCBT Brief Cognitive Behavioral Therapy for suicide. If successful, this study would result in a combined treatment to decrease suicide ideation and related behaviors. The proposal addresses HSRD post-deployment health priority, specifically suicide prevention and is innovative in that it will be the first study to examine efficacy of combined treatment specifically for suicide prevention. |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase ICMJE | Phase 2 Phase 3 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: 130 Veterans admitted to the Providence VAMC psychiatric inpatient unit due to suicide attempt or ideation with intent to make an attempt will be recruited and randomly assigned to receive: a) active TMS+BCBT or b) sham TMS+BCBT. Both interventions will begin within the week following hospital discharge, and Veterans will be followed for 12 months post-discharge. Masking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Prior to each TMS session, un-blinded study staff will attach the appropriate (i.e., active or sham) coil according to the participants' randomization code (obtained from the urn randomization computer program). This will facilitate "triple blind" stimulation, where the participant, TMS provider, and outcome rater are blind to group assignation. Primary Purpose: Treatment
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| Condition ICMJE | Suicide | ||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE |
130 | ||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||
| Estimated Study Completion Date ICMJE | March 31, 2023 | ||||||||
| Estimated Primary Completion Date | March 31, 2023 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria: -Suicide attempt or suicidal ideation with intent to make a suicide attempt within 48 hours of hospitalization as indicated on the hospital chart and confirmed by administration of the C-SSRS. Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT03952468 | ||||||||
| Other Study ID Numbers ICMJE | IIR 17-201 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | VA Office of Research and Development | ||||||||
| Study Sponsor ICMJE | VA Office of Research and Development | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| PRS Account | VA Office of Research and Development | ||||||||
| Verification Date | February 2021 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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