Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide

VA Office of Research and Development55 enrolled

Overview

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.

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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). * 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. * 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

Outcomes

Primary Outcomes

Columbia Suicide Severity Rating Scale (CSSRS) (Suicide Composite)

The Columbia suicide severity rating scale is an interview-administered assessment of suicide ideation and behavior. The full CSSRS interview consists of two subscales, an ideation and behavior subscale. The primary outcome measure for this study utilized the behavior subscale. A study-created composite score was calculated by adding the total number of: 1) suicide attempts, 2) interrupted attempts, and 3) aborted attempts in the specified time frame. At baseline total number of behaviors covered lifetime number of total behaviors prior to baseline. Each subsequent assessment period assesses total number of behaviors since time of last assessment (e.g., endpoint = total number of behaviors from baseline to end of 12-week BCBT course, 6-month follow up = total number of behaviors from endpoint to 6 months post-baseline, 12 months = total number of behaviors from 6 month follow up to 12 month follow up.

Time frame: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up

Secondary Outcomes

Beck Scale for Suicide Ideation (BSSI)

The BSSI is a 21-item measure designed to assess the severity of suicidal thoughts in the week prior to evaluation. 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 scored based on an ordinal scale from 0-2 and the total score range is 0-38 with higher scores indicating greater severity. The SSI total score is obtained by adding up the ratings (0-2) from the first 19 items.

Time frame: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up

The Longitudinal Interval Follow-up Evaluation (LIFE): Psychiatric Status Rating Scale for Suicidal Ideation

The Longitudinal Interval Follow-up Evaluation (LIFE) is a timeline follow up interview measure that is administered at each of the assessment period. Participants are asked to describe their weekly suicidal thoughts and interviewers rate them on a 6-point Likert score ranging from 1 (not at all) to 6 (Extreme: has made preparations for a potentially serious suicide attempt). Data is then converted into the presence/absence of suicidal thoughts for each week of the follow up period. Data reported includes the mean number of weeks with reported suicidal thoughts (scores above 2).

Time frame: Endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up

Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)

The WHODAS 2.0 is a 36-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. Total score is calculated by summing the item scores and then converted into a standardized score ranging from 0-100 with higher scores indicating greater disability.

Time frame: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up

Treatment History Interview THI: Emergency Services

The THI is an interview used to collect information about psychotherapy, hospitalizations, medical treatment, pharmacotherapy, and other means of psychologically-related help that a person may use. For this study we assessed the use of emergency services (emergency room visits for psychiatric reasons and hospitalizations for psychiatric reasons). Outcome was the number of times a participant used either emergency department or was hospitalized for mental health reasons.

Time frame: Endpoint (following a 12-week course of BCBT), 6-month follow-up, 12-month follow-up

Brief Symptom Inventory: Psychiatric Symptoms

The BSI is a 53-item self-report questionnaire developed by Derogatis and Melisarotos to measure psychological distress and assess the severity of symptom across the following dimensions: Somatization, Obsession-compulsion, interpersonal sensitivity , depression, anxiety, hostility, phobic anxiety, paranoid ideation, psychoticism. Items are rated on a 5-point Likert scale from 0-4. The Global severity index (GSI) was used and reported. GSI is a mean score for all items across all dimensions. Higher scores are indicative of greater psychological distress.

Time frame: Baseline, endpoint (end of 12-week BCBT course), 6-month follow-up, and 12 month follow up

Combined TMS and Brief Cognitive Behavioral Therapy to Reduce Suicide

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes