Evaluation of a Computerized Intervention for Learning to Re-Evaluate Suicidal Thoughts

NCT04254809 | Terminated Results

• 1 other identifier: 2019.28553
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

As rates of suicide have increased over the last several decades, research has identified that roughly two-thirds of individuals who attempt suicide do so within one year from the time that they begin to think about suicide. This suggests a greater need for interventions designed to specifically help individuals learn to cope with thoughts of suicide to interrupt the process by which thoughts may lead to suicidal behaviors (i.e, attempts). This study aims to develop and test a novel intervention designed to help individuals feel more confident in their ability to manage thoughts of suicide. It is common that individuals with suicidal ideation may not understand where thoughts of suicide come from and are therefore distressed at the prospect they might never escape these thoughts. As a result, these individuals may attempt to distract from or avoid these thoughts in ways that contribute to suicidal ideation becoming more frequent and intense over the long-term. This 'experiential avoidance' of suicidal ideation is therefore an excellent target for treatment and has in fact been shown to help reduce the distress associated with suicidal thoughts in several treatment studies. The intervention to be tested in this study seeks to reduce the distress related to suicidal thoughts by explaining that these thoughts are a normative response to extreme stress, and provides strategies that help individuals observe that suicidal thoughts are temporary (i.e., will not last "forever") and something they can tolerate without needing to rigidly control them. To maximize the potential of this intervention to help the largest number of individuals, it is entirely computerized and takes only 30 minutes to complete. This will help reduce many of the traditional barriers to treatment that individuals with suicidal ideation face (e.g., costs, time restrictions, and stigma of help-seeking). Individuals (N=106) with current suicidal ideation will be randomly assigned to participate in either the experiential avoidance intervention for suicidal thoughts or a control intervention. Experiential avoidance (i.e., distress or avoidance) and severity of suicide risk will be measured one week, and one month after participants complete their assigned intervention. It is expected that, compared to controls, individuals who receive the experiential avoidance intervention will report: 1) less experiential avoidance at one week follow-up, and 2) less severe suicide risk at one-month follow-up.

Conditions

Suicidal Ideation

Outcome Measures

Primary Outcomes (2)

• Standardized Residual Change in Experiential Avoidance of Suicidal Ideation

  Data sourced from Acceptance and Action Questionnaire for Suicidal Ideation (AAQ-SI) self-report measure total scores. AAQ-SI scores range from 4-28, higher scores indicate greater experiential avoidance of suicidal ideation. Standardized residual change calculated by regressing AAQ-SI scores at one week onto AAQ-SI scores at baseline. Positive values mean experiential avoidance of suicidal ideation increased relative to rest of sample. Negative values mean it decreased relative to rest of sample. Values follow a normal distribution, with nearly all falling between -3 and +3.

  Baseline and One week

• Standardized Residual Change in Suicide Risk Severity

  Data sourced from Beck Scale for Suicidal Ideation (BSS) self-report measure total score. BSS scores range from 0-38, higher scores indicate greater suicide risk severity. Standardized residual change calculated by regressing BSS scores at one month onto BSS scores at baseline. Positive values mean suicide risk severity increased relative to rest of sample. Negative values mean it decreased relative to rest of sample.

  Baseline and one month

Secondary Outcomes (1)

• Standardized Residual Change in Cognitive Avoidance of Suicidal Ideation

  Baseline and One week

Study Arms (2)

Re-Evaluating Suicidal Thoughts

EXPERIMENTAL

Participants in this condition will complete the experimental intervention at the baseline appointment.

Behavioral: Re-Evaluating Suicidal Thoughts

Healthy Social Living

SHAM COMPARATOR

Participants in this condition will complete the sham control intervention at the baseline appointment, and given the option to complete the experimental intervention at the conclusion of the follow-up period.

Behavioral: Healthy Social Living

Interventions

Re-Evaluating Suicidal Thoughts BEHAVIORAL

Re-Evaluating Suicidal Thoughts (REST) is a is a computerized intervention designed to mitigate the experiential avoidance of suicidal thoughts. Over the course of approximately 30 minutes, individuals are provided with psychoeducation regarding the incidence rate, origin, conceptualization, and misconceptions of suicidal thoughts. Empirical evidence is presented to provide a scientific understanding of suicidal thoughts, and is aided through the use of metaphors to make concepts more accessible to viewers. REST draws from therapeutic strategies rooted in cognitive behavioral therapy (CBT) and Acceptance and Commitment Therapy (ACT) to further suggest tips for accepting (cp. approving of) the occurrence of suicidal thoughts, and introduces mindfulness and acceptance strategies for coping with them.

Re-Evaluating Suicidal Thoughts

Healthy Social Living BEHAVIORAL

To control for potential effects of time and presentation of educational material on study outcome variables, participants randomized to the control intervention will complete a computerized psychoeducation program regarding the benefits of social support networks. Across approximately 20 minutes of audiovisual slides, participants are informed of the ways in which social connections buffer against loneliness and facilitate social learning, provided tips for expanding and maintaining their social network, and administered a brief quiz to assess for comprehension.

Healthy Social Living

Eligibility Criteria

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

You may qualify if:

• Suicidal ideation during the past two-weeks

You may not qualify if:

• Imminent risk for attempting suicide, requiring hospitalization
• Unmedicated psychotic spectrum or bipolar disorders

Sponsors & Collaborators

• Florida State University: lead

Study Sites (1)

Florida State University

Tallahassee, Florida, 32304, United States

Location

MeSH Terms

Conditions

Suicidal Ideation

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Limitations and Caveats

Early termination prevented achieving recruitment target, but total number analyzed still exceeded the sample size necessary to detect medium effects in a priori power analysis. Intention-to-treat with lost observation carried forward was used to handle missing data and may not account for true scores at follow-up. However, the same pattern of results held for experiential avoidance and suicidal ideation severity among a completer sample. Those results are available upon request from the PI.

Results Point of Contact

• Title: Joseph Boffa, PhD
• Organization: Southeast Louisiana Veterans Health Care System

joseph.boffa@va.gov

504-507-2000

Study Officials

• Joseph Boffa, MS

  Florida State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participant are blind to condition randomization, as are clinicians who provide suicide risk assessments throughout the follow-up period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants are randomized upon enrollment to one of two conditions: Re-Evaluating Suicidal Thoughts (active condition) or Healthy Social Living (control condition).

Study Record Dates

• First Submitted: February 2, 2020
• First Posted: February 5, 2020
• Study Start: September 27, 2018
• Primary Completion: March 1, 2020
• Study Completion: August 1, 2020
• Last Updated: December 6, 2021
• Results First Posted: December 3, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)