Last reviewed · How we verify

NCT04254809: REST

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

Terminated NA Results posted Last updated 6 December 2021
What this trial tests

NA trial testing Re-Evaluating Suicidal Thoughts in Suicidal Ideation in 96 participants. Terminated before completion.

Timeline
27 September 2018
Primary endpoint
1 March 2020
1 August 2020

Quick facts

Lead sponsorFlorida State University
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment96
Start date27 September 2018
Primary completion1 March 2020
Estimated completion1 August 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Florida State University

Who can join

18 and older, any sex, with Suicidal Ideation. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Standardized Residual Change in Experiential Avoidance of Suicidal Ideation Primary · Baseline and One week

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.

GroupValue95% CI
Re-Evaluating Suicidal Thoughts-0.32± 0.88
Healthy Social Living0.32± 1.01
Standardized Residual Change in Suicide Risk Severity Primary · Baseline and one month

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.

GroupValue95% CI
Re-Evaluating Suicidal Thoughts-0.31± 0.87
Healthy Social Living0.31± 1.03
Standardized Residual Change in Cognitive Avoidance of Suicidal Ideation Secondary · Baseline and One week

Data sourced from White Bear Suppression Inventory for Suicidal Ideation (WBSI-SI) self-report measure distraction and suppression subscale score. WBSI-SI avoidance subscale scores range from 7-35, higher scores indicate greater cognitive avoidance of suicidal ideation. Standardized residual change calculated by regressing WBSI-SI avoidance scores at one week onto WBSI-SI avoidance scores at baseline. Positive values mean cognitive avoidance of suicidal ideation increased relative to rest of sample. Negative values mean it decreased relative to rest of sample.

GroupValue95% CI
Re-Evaluating Suicidal Thoughts-.23± 1.18
Healthy Social Living0.23± 0.71

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other trials of Re-Evaluating Suicidal Thoughts

Trials testing the same drug.

Other recruiting trials for Suicidal Ideation

Currently open trials in the same condition.

Other Florida State University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04254809.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing