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Suicidal IdeationRESTNCT04254809

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

A study testing Re-Evaluating Suicidal Thoughts and Healthy Social Living in people with Suicidal Ideation, run by Florida State University at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Suicidal Ideation
What is being tested?
Re-Evaluating Suicidal Thoughts and Healthy Social Living
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
96 participants
Where
1 siteUnited States
Study dates
27 Sep 2018to 1 Aug 2020
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Suicidal ideation during the past two-weeks

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Florida State University

    Tallahassee, Florida, 32304

Other trials in United States

About this study

Official title: Evaluating a Web-based Intervention for Reactions to Suicidal Thoughts

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.

Read more

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.

Read the 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.

Being tested
Re-Evaluating Suicidal Thoughts, Healthy Social Living
Medical subject headings
Suicidal Ideation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Re-Evaluating Suicidal ThoughtsBehavioural

    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 LivingBehavioural

    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.

Study groups in NCT04254809
Study groupRoleWhat they receive
Re-Evaluating Suicidal ThoughtsExperimentalParticipants in this condition will complete the experimental intervention at the baseline appointment.
Receives: Behavioral: Re-Evaluating Suicidal Thoughts
Healthy Social LivingSham comparatorParticipants 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.
Receives: Behavioral: Healthy Social Living

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and One week

  2. 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.

    Measured: Baseline and one month

Secondary outcomes (1)
  1. Standardized Residual Change in Cognitive Avoidance of Suicidal Ideation

    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.

    Measured: Baseline and One week

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2020
  2. Study start27 Sep 2018
  3. Primary completion1 Mar 2020
  4. Study completion1 Aug 2020

Why it stopped: Face-to-face appointments, which were required by the IRB for suicide risk evaluation, were suspended by the IRB during the COVID-19 pandemic. During this pause, the PI left the institution. Thus, all study activities were terminated.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomized upon enrollment to one of two conditions: Re-Evaluating Suicidal Thoughts (active condition) or Healthy Social Living (control condition).
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
96 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04254809
Sponsor's protocol ID
2019.28553
Other IDs
2019
Acronym
REST
Status last verified
Dec 2021
First submitted
2 Feb 2020
Last updated
6 Dec 2021
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Re-Evaluating Suicidal Thoughts and Healthy Social Living in people with Suicidal Ideation, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Standardized Residual Change in Experiential Avoidance of Suicidal Ideation (time frame: Baseline and One week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2021.

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