A Randomized Clinical Trial Testing the Effectiveness of Telemental Health for Suicidal Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-12

Study Completion Date

2024-12-30

Brief Summary

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The long-term goal of this study is to reduce suicidal thoughts and behaviors among treatment-seeking individuals who are experiencing suicidal thoughts or have recently made a suicide attempt. Brief cognitive behavioral therapies for suicide prevention (BCBT) has demonstrated empirical support for reducing suicide attempts as compared to treatment as usual. However, no studies to date have assessed their effectiveness when delivered via telehealth, highlighting an important knowledge gap in light of increased use of telehealth subsequent to the outbreak of the novel coronavirus (COVID-19) in the U.S. In light of this knowledge gap, the primary objective of this study will be to test the effectiveness of brief cognitive behavioral therapy (BCBT) as compared to present-centered therapy (PCT), an active comparator, for the reduction of suicide ideations and attempts when delivered via telehealth.

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Detailed Description

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Suicide remains one of the top 10 causes of death in the United States. Since 1999, the age-adjusted suicide rate has increased by approximately 33%, from 10.5 per 100,000 in 1999 up to 14.0 per 100,000 in 2017. Cognitive behavioral therapies are empirically supported for the rapid reduction of suicidal thoughts and behaviors, especially when they are delivered in an individual therapy (versus group therapy) format. One particular protocol-brief cognitive behavioral therapy for suicide prevention (BCBT)-was developed by our research team and tested in a sample of active duty military personnel in a randomized clinical trial. Results of that study showed that service members receiving BCBT were 60% less likely to attempt suicide during the two-year follow-up and showed faster reductions in suicide ideation as compared to service members receiving treatment as usual (TAU). A recently completed pilot randomized clinical trial similarly found a large reduction in suicide attempt rates among adolescents and young adults who received BCBT as compared to TAU (0% vs. 25%).

Unfortunately, fewer than half of suicide decedents and individuals with past-year suicide ideation seek out mental health treatment. While several factors influence the decision to use (or not use) mental health services, logistical barriers such as insufficient time and/or geographic location are among the most commonly cited reasons for choosing not to access treatment. Telehealth services can address this disparity due to reduced need for travel and less time away from school and/or work, which can increase attendance rates to medical appointments. Evidence also suggests that delivering mental health services via telehealth improves help-seeking behaviors. Although numerous studies indicate that the efficacy of empirically-supported treatments for a wide range of mental health conditions are not diminished when delivered via telehealth, no studies have examined the effects of suicide-focused treatment protocols when delivered in this format.

The present study aims to address this knowledge gap by testing the effectiveness of BCBT when delivered via telehealth as compared to present-centered therapy (PCT), an active comparator that has been shown to significantly reduce suicide ideation. The results of this study would provide critical information about the effectiveness of BCBT when delivered via telehealth.

Conditions

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Suicide Suicidal Ideation Suicide Attempt

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Brief Cognitive Behavioral Therapy (BCBT)

Group Type EXPERIMENTAL

Brief Cognitive Behavioral Therapy (BCBT)

Intervention Type BEHAVIORAL

BCBT is divided into three phrases. In phase I (5 sessions), the therapist conducts a detailed assessment of the patient's most recent suicidal episode or suicide attempt, identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills such as relaxation and mindfulness. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.

Present-Centered Therapy (PCT)

Group Type ACTIVE_COMPARATOR

Present-Centered Therapy (PCT)

Intervention Type BEHAVIORAL

PCT includes (1) psychoeducation about the typical symptoms and features associated with suicidal thoughts and behaviors; (2) normalization of symptoms; (3) experience of receipt of support and feedback from a licensed professional; and (4) positive interpersonal interactions. PCT differs from BCBT in several key ways including less structure (i.e., patients are allowed to have more input into PCT session agendas) and no systematic training in behavioral or cognitive strategies for managing emotions and changing suicide-focused thoughts. PCT will be used as an active comparator because it is an empirically supported treatment for depression and PTSD that also reduces suicidal ideation (Bryan et al., 2016; Resick et al., 2017), but contains unique elements that distinguish the treatment from BCBT.

Interventions

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Brief Cognitive Behavioral Therapy (BCBT)

BCBT is divided into three phrases. In phase I (5 sessions), the therapist conducts a detailed assessment of the patient's most recent suicidal episode or suicide attempt, identifies patient-specific factors that contribute to and maintain suicidal behaviors, provides a cognitive-behavioral conceptualization, collaboratively develops a crisis response plan, and teaches basic emotion regulation skills such as relaxation and mindfulness. In phase II (5 sessions), the therapist applies cognitive strategies to reduce beliefs and assumptions that serve as vulnerabilities to suicidal behavior. In phase III (2 sessions), a relapse prevention task is conducted.

Intervention Type BEHAVIORAL

Present-Centered Therapy (PCT)

PCT includes (1) psychoeducation about the typical symptoms and features associated with suicidal thoughts and behaviors; (2) normalization of symptoms; (3) experience of receipt of support and feedback from a licensed professional; and (4) positive interpersonal interactions. PCT differs from BCBT in several key ways including less structure (i.e., patients are allowed to have more input into PCT session agendas) and no systematic training in behavioral or cognitive strategies for managing emotions and changing suicide-focused thoughts. PCT will be used as an active comparator because it is an empirically supported treatment for depression and PTSD that also reduces suicidal ideation (Bryan et al., 2016; Resick et al., 2017), but contains unique elements that distinguish the treatment from BCBT.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* 18 years of age or older;
* a score of 5 or higher on the Scale for Suicide Ideation and/or a suicide attempt within the past month;
* ability to understand and speak the English language;
* ability to complete the informed consent process;
* regular access to a stable internet connection; and
* ownership of an internet-enable communication device (e.g., computer, tablet, smartphone).

Exclusion Criteria

* substance use disorder requiring acute medical management;
* imminent suicide risk warranting inpatient hospitalization; and
* impaired mental status that precludes the ability to provide informed consent (e.g., intoxication, psychosis, mania).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No