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

Sponsor
Florida State University (Other)
Overall Status
Terminated
CT.gov ID
NCT04254809
Collaborator
(none)
96
1
2
22.1
4.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Re-Evaluating Suicidal Thoughts
  • Behavioral: Healthy Social Living
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
96 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants are randomized upon enrollment to one of two conditions: Re-Evaluating Suicidal Thoughts (active condition) or Healthy Social Living (control condition).Participants are randomized upon enrollment to one of two conditions: Re-Evaluating Suicidal Thoughts (active condition) or Healthy Social Living (control condition).
Masking:
Double (Participant, Outcomes Assessor)
Masking Description:
Participant are blind to condition randomization, as are clinicians who provide suicide risk assessments throughout the follow-up period.
Primary Purpose:
Treatment
Official Title:
Evaluating a Web-based Intervention for Reactions to Suicidal Thoughts
Actual Study Start Date :
Sep 27, 2018
Actual Primary Completion Date :
Mar 1, 2020
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Re-Evaluating Suicidal Thoughts

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

Behavioral: 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.

Sham Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. Standardized Residual Change in Experiential Avoidance of Suicidal Ideation [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.

  2. Standardized Residual Change in Suicide Risk Severity [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.

Secondary Outcome Measures

  1. Standardized Residual Change in Cognitive Avoidance of Suicidal Ideation [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Suicidal ideation during the past two-weeks
Exclusion Criteria:
  • Imminent risk for attempting suicide, requiring hospitalization

  • Unmedicated psychotic spectrum or bipolar disorders

Contacts and Locations

Locations

Site City State Country Postal Code
1 Florida State University Tallahassee Florida United States 32304

Sponsors and Collaborators

  • Florida State University

Investigators

  • Principal Investigator: Joseph Boffa, MS, Florida State University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Joseph William Boffa, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier:
NCT04254809
Other Study ID Numbers:
  • 2019.28553
First Posted:
Feb 5, 2020
Last Update Posted:
Dec 6, 2021
Last Verified:
Dec 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Re-Evaluating Suicidal Thoughts Healthy Social Living
Arm/Group Description Participants in this condition will complete the experimental intervention at the baseline appointment. 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. 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. 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.
Period Title: Overall Study
STARTED 48 48
COMPLETED 43 38
NOT COMPLETED 5 10

Baseline Characteristics

Arm/Group Title Re-Evaluating Suicidal Thoughts Healthy Social Living Total
Arm/Group Description Participants in this condition will complete the experimental intervention at the baseline appointment. 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. 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. 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. Total of all reporting groups
Overall Participants 48 48 96
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
19.54
(2.53)
19.29
(2.42)
19.42
(2.47)
Sex: Female, Male (Count of Participants)
Female
38
79.2%
39
81.3%
77
80.2%
Male
10
20.8%
9
18.8%
19
19.8%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
14
29.2%
15
31.3%
29
30.2%
Not Hispanic or Latino
34
70.8%
33
68.8%
67
69.8%
Unknown or Not Reported
0
0%
0
0%
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
2.1%
0
0%
1
1%
Asian
5
10.4%
0
0%
5
5.2%
Native Hawaiian or Other Pacific Islander
0
0%
0
0%
0
0%
Black or African American
8
16.7%
6
12.5%
14
14.6%
White
32
66.7%
41
85.4%
73
76%
More than one race
2
4.2%
1
2.1%
3
3.1%
Unknown or Not Reported
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
48
100%
48
100%
96
100%
Patient Health Questionnaire-8 (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]
20.85
(5.50)
22.54
(5.62)
21.70
(5.59)

Outcome Measures

1. Primary Outcome
Title Standardized Residual Change in Experiential Avoidance of Suicidal Ideation
Description 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.
Time Frame Baseline and One week

Outcome Measure Data

Analysis Population Description
Intention to treat analyses carried last observation forward for all participants enrolled at baseline.
Arm/Group Title Re-Evaluating Suicidal Thoughts Healthy Social Living
Arm/Group Description Participants in this condition will complete the experimental intervention at the baseline appointment. 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. 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. 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.
Measure Participants 48 48
Mean (Standard Deviation) [Unitless]
-0.32
(0.88)
0.32
(1.01)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Re-Evaluating Suicidal Thoughts, Healthy Social Living
Comments Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regressing scores at one-week follow-up onto scores at baseline.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .001
Comments Threshold for statistical significance was p = .05
Method Regression, Linear
Comments
Method of Estimation Estimation Parameter Slope
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-1.02 to -0.25
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.19
Estimation Comments REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL
2. Primary Outcome
Title Standardized Residual Change in Suicide Risk Severity
Description 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.
Time Frame Baseline and one month

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Re-Evaluating Suicidal Thoughts Healthy Social Living
Arm/Group Description Participants in this condition will complete the experimental intervention at the baseline appointment. 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. 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. 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.
Measure Participants 48 48
Mean (Standard Deviation) [Unitless]
-0.31
(0.87)
0.31
(1.03)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Re-Evaluating Suicidal Thoughts, Healthy Social Living
Comments Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-month follow-up onto scores at baseline.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .002
Comments Threshold for significance was p = .05
Method Regression, Linear
Comments
Method of Estimation Estimation Parameter Slope
Estimated Value -0.61
Confidence Interval (2-Sided) 95%
-0.99 to -0.23
Parameter Dispersion Type: Standard Error of the Mean
Value: 0.19
Estimation Comments REST coded as 0, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL
3. Secondary Outcome
Title Standardized Residual Change in Cognitive Avoidance of Suicidal Ideation
Description 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.
Time Frame Baseline and One week

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Re-Evaluating Suicidal Thoughts Healthy Social Living
Arm/Group Description Participants in this condition will complete the experimental intervention at the baseline appointment. 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. 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. 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.
Measure Participants 48 48
Mean (Standard Deviation) [Unitless]
-.23
(1.18)
0.23
(0.71)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Re-Evaluating Suicidal Thoughts, Healthy Social Living
Comments Intention to treat analyses carried last observation forward for all participants enrolled at baseline. Standardized residual change score calculated by regression scores at one-week follow-up onto scores at baseline.
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value .03
Comments Threshold for statistical significance was p = .05
Method Regression, Linear
Comments
Method of Estimation Estimation Parameter Slope
Estimated Value -0.45
Confidence Interval (2-Sided) 95%
-0.86 to -.05
Parameter Dispersion Type: Standard Error of the Mean
Value: .20
Estimation Comments REST coded as -, HSL coded as 1; negative slope reflects greater standardized reductions in outcome among REST compared to HSL.

Adverse Events

Time Frame Up to one month follow-up.
Adverse Event Reporting Description
Arm/Group Title Re-Evaluating Suicidal Thoughts Healthy Social Living
Arm/Group Description Participants in this condition will complete the experimental intervention at the baseline appointment. 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. 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. 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.
All Cause Mortality
Re-Evaluating Suicidal Thoughts Healthy Social Living
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/48 (0%) 0/48 (0%)
Serious Adverse Events
Re-Evaluating Suicidal Thoughts Healthy Social Living
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/48 (0%) 0/48 (0%)
Other (Not Including Serious) Adverse Events
Re-Evaluating Suicidal Thoughts Healthy Social Living
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/48 (0%) 0/48 (0%)

Limitations/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.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Joseph Boffa, PhD
Organization Southeast Louisiana Veterans Health Care System
Phone 504-507-2000 ext 67372
Email joseph.boffa@va.gov
Responsible Party:
Joseph William Boffa, Principal Investigator, Florida State University
ClinicalTrials.gov Identifier:
NCT04254809
Other Study ID Numbers:
  • 2019.28553
First Posted:
Feb 5, 2020
Last Update Posted:
Dec 6, 2021
Last Verified:
Dec 1, 2021