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

NCT04844294 | Completed

• 1 other identifier: 2020B0396
• Study Type: interventional
• Target: 98
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Suicide; Suicidal Ideation; Suicide Attempt

Keywords

Telemental health; Telemedicine; Cognitive Behavioral Therapy

Outcome Measures

Primary Outcomes (2)

• Change in number of suicide attempts from baseline.

  The change in number of suicide attempts will be assessed using the Self-injurious thoughts and behaviors interview-Revised (SITBI-R). The SITBI-R is an empirically-supported researcher-administered structured interview for assessing the characteristics and features of self-injurious thoughts and behaviors, and to distinguish different types of suicidal and self-injurious behaviors. An increased number of suicide attempts at any assessment is considered a worse outcome.

  Baseline, 3, 6, 9, and 12 month follow-up.

• Change in severity of suicide ideation from baseline.

  The change in severity of suicide ideation will be assessed using the Scale for Suicide Ideation (SSI), a 19-item 3-point likert scale where higher scores indicate increased severity of suicide ideation. Summed total scores for these items range from 0-38. The SSI is an empirically-supported researcher-administered interview that assesses the intensity of suicide-related thoughts, urges, intentions, and behaviors. All participants complete the first 5 items. If a subject positively endorses either item 4 (active ideation) or item 5 (passive ideation), they are directed to complete an additional 14 items.

  Baseline, during treatment, 3, 6, 9, and 12 month follow-up.

Secondary Outcomes (1)

• Change in psychiatric symptom severity will be measured across multiple time points post-treatment.

  Baseline, during treatment, 3, 6, 9, and 12 month follow-up.

Study Arms (2)

Brief Cognitive Behavioral Therapy (BCBT)

EXPERIMENTAL

Behavioral: Brief Cognitive Behavioral Therapy (BCBT)

Present-Centered Therapy (PCT)

ACTIVE COMPARATOR

Behavioral: Present-Centered Therapy (PCT)

Interventions

Brief Cognitive Behavioral Therapy (BCBT) 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.

Brief Cognitive Behavioral Therapy (BCBT)

Present-Centered Therapy (PCT) 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.

Present-Centered Therapy (PCT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (5)

• Rudd MD, Bryan CJ, Wertenberger EG, Peterson AL, Young-McCaughan S, Mintz J, Williams SR, Arne KA, Breitbach J, Delano K, Wilkinson E, Bruce TO. Brief cognitive-behavioral therapy effects on post-treatment suicide attempts in a military sample: results of a randomized clinical trial with 2-year follow-up. Am J Psychiatry. 2015 May;172(5):441-9. doi: 10.1176/appi.ajp.2014.14070843. Epub 2015 Feb 13.

  PMID: 25677353 BACKGROUND

• Sinyor M, Williams M, Mitchell R, Zaheer R, Bryan CJ, Schaffer A, Westreich N, Ellis J, Goldstein BI, Cheung AH, Selchen S, Kiss A, Tien H. Cognitive behavioral therapy for suicide prevention in youth admitted to hospital following an episode of self-harm: A pilot randomized controlled trial. J Affect Disord. 2020 Apr 1;266:686-694. doi: 10.1016/j.jad.2020.01.178. Epub 2020 Jan 30.

  PMID: 32056945 BACKGROUND

• Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.

  PMID: 16077050 BACKGROUND

• Bryan CJ, Clemans TA, Hernandez AM, Mintz J, Peterson AL, Yarvis JS, Resick PA; STRONG STAR Consortium. EVALUATING POTENTIAL IATROGENIC SUICIDE RISK IN TRAUMA-FOCUSED GROUP COGNITIVE BEHAVIORAL THERAPY FOR THE TREATMENT OF PTSD IN ACTIVE DUTY MILITARY PERSONNEL. Depress Anxiety. 2016 Jun;33(6):549-57. doi: 10.1002/da.22456. Epub 2015 Dec 4.

  PMID: 26636426 BACKGROUND

• Baker JC, Starkey A, Ammendola E, Bauder CR, Daruwala SE, Hiser J, Khazem LR, Rademacher K, Hay J, Bryan AO, Bryan CJ. Telehealth Brief Cognitive Behavioral Therapy for Suicide Prevention: A Randomized Clinical Trial. JAMA Netw Open. 2024 Nov 4;7(11):e2445913. doi: 10.1001/jamanetworkopen.2024.45913.

  PMID: 39531231 DERIVED

MeSH Terms

Conditions

Suicide; Suicidal Ideation; Suicide, Attempted

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Justin C Baker, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 31, 2021
• First Posted: April 14, 2021
• Study Start: April 12, 2021
• Primary Completion: September 30, 2024
• Study Completion: December 30, 2024
• Last Updated: March 5, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)