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

NCT ID: NCT04254809

Last Updated: 2021-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-27
• Study Completion Date: 2020-08-01

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.

Detailed Description

Each year in the United States nearly 47,000 people die by suicide. Despite over 50 years of suicide prevention research, the field is no closer to identifying specific factors which influence the transition of suicidal ideation to suicide attempts. Research suggests upwards of 60% of individuals with suicidal ideation progress to making suicide plans or attempts within 1 year, suggesting a specific, pernicious process is involved in this escalation. Identifying which mechanisms contribute to the escalation of new-onset suicidal ideation is crucial to developing interventions that target these underlying processes.

Conceptual models of suicide have long viewed suicidal ideation and behaviors as a form of escape or avoidance from psychological distress with which individuals do not know how to cope. Indeed, psychiatric disorders are roughly 4 times as prevalent among suicidal ideators compared to non-ideators, and it is estimated 90% of suicide decedents evinced at least one psychiatric disorder. Several empirical models of psychiatric disorders implicate behavioral or experiential (i.e., emotional) avoidance as a driving mechanism of symptom severity (i.e., psychological distress. Similar to other psychiatric symptoms, suicidal ideation is distressing insofar as some individuals view such thoughts as incompatible with their natural instinct for self-preservation. To the extent that individuals respond to suicidal ideation with avoidance, such responses may in part be responsible for the escalation of suicidal ideation to plans or attempts.

Incidentally, models of psychological flexibility indicate a primary role for experiential avoidance and have been applied to suicidal ideation and behaviors. Higher levels of experiential avoidance are prospectively and concurrently associated with suicidal thoughts and behaviors. Moreover, as a cognitive-behavioral indicator of experiential avoidance, efforts to avoid or suppress suicidal thoughts are associated with greater concurrent levels of suicidal ideation and risk, and relate to a paradoxical increase in the severity of suicidal ideation over time.

Taken together, these studies suggest that individuals high in experiential avoidance with concomitant suicidal ideation may benefit from interventions that mitigate experience avoidance. Such interventions would ideally limit the psychological distress associated with the occurrence of suicidal thoughts, and improve one's ability to adaptively cope with suicidal thoughts rather than seeking to avoid, control, or suppress such thoughts. Indeed, preliminary evidence suggests treatment modalities that incorporate this approach (i.e., Acceptance and Commitment Therapy [ACT]) reduce suicidal ideation. Unfortunately, as with most traditional psychotherapies, this evidence stems from studies that required participants to attend numerous in-person sessions with a trained psychotherapist. Outside of treatment studies, the time and costs associated with this treatment would likely serve as a barrier to individuals with suicidal ideation, who represent a segment of the population that critically underutilize these types of mental health services. In order to increase suicide prevention efforts, it would be beneficial to develop ACT-based interventions that are more scalable and thus have the potential to address the needs of a greater number of individuals with suicidal ideation.

The current study therefore aims to develop and test a brief, web-based intervention primarily focused on reducing experiential avoidance of suicidal ideation among individuals with current SI (N = 106). The study will consist of one baseline appointment (in person), and two follow-up appointments one week (phone/online) and one month (phone/online) following their baseline appointment. At the baseline appointment, participants will complete measures of suicidal ideation severity and experiential avoidance. They will then be randomized to complete either the computerized experiential avoidance intervention or a healthy living control video safety planning with a clinician. Per best practices for maintaining participant safety, following intervention condition, all participants will receive the Safety Planning Intervention. One week after the baseline appointment, participants will complete a suicide risk assessment over the telephone, during which time they will also complete self-report measures of experiential avoidance and suicidal ideation severity. These same procedures will be conducted again one month after baseline.

It is hypothesized that, compared to healthy living controls, individuals who receive the experiential avoidance intervention will report: 1) less experiential avoidance at one week follow-up, and 2) less severe suicidal ideation at one-month follow-up.

Conditions

Suicidal Ideation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Re-Evaluating Suicidal Thoughts

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

Group Type: EXPERIMENTAL

Re-Evaluating Suicidal Thoughts

Intervention Type: 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.

Healthy Social Living

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.

Group Type: SHAM_COMPARATOR

Healthy Social Living

Intervention Type: 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.

Interventions

Re-Evaluating Suicidal Thoughts

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.

Intervention Type: BEHAVIORAL

Healthy Social Living

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Suicidal ideation during the past two-weeks

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Florida State University

OTHER

Sponsor Role: lead

Responsible Party

Joseph William Boffa

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joseph Boffa, MS

Role: PRINCIPAL_INVESTIGATOR

Florida State University

Locations

Florida State University

Tallahassee, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

2019.28553

Identifier Type: -

Identifier Source: org_study_id