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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Suicidal Ideation
- 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 group | Role | What they receive |
|---|---|---|
| Re-Evaluating Suicidal Thoughts | Experimental | Participants in this condition will complete the experimental intervention at the baseline appointment. Receives: 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. Receives: Behavioral: Healthy Social Living |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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)
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.
- First posted5 Feb 2020
- Study start27 Sep 2018
- Primary completion1 Mar 2020
- 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
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Florida State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph William Boffa, Florida State University
- Investigators
- Joseph Boffa, MS, Principal investigator, Florida State University
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Web-based Intervention for Reactions to Suicidal Thoughts
- ClinicalTrials.gov ID
- NCT04254809
- Acronym / sponsor ID
- REST / 2019.28553
- Conditions
- Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- TerminatedReason 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.
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Florida State UniversityUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 1 Mar 2020 (actual)
- Study completion
- 1 Aug 2020 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Posted 3 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are randomized upon enrollment to one of two conditions: Re-Evaluating Suicidal Thoughts (active condition) or Healthy Social Living (control condition).
| Arm | Type | Receives |
|---|---|---|
| Re-Evaluating Suicidal Thoughts | Experimental | Behavioral: Re-Evaluating Suicidal ThoughtsParticipants in this condition will complete the experimental intervention at the baseline appointment. |
| Healthy Social Living | Sham comparator | Behavioral: Healthy Social LivingParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suicidal ideation during the past two-weeks
Key exclusion criteria (2 listed)
- Imminent risk for attempting suicide, requiring hospitalization
- Unmedicated psychotic spectrum or bipolar disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Re-Evaluating Suicidal ThoughtsRe-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. | Behavioural | Re-Evaluating Suicidal Thoughts |
| Healthy Social LivingTo 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. | Behavioural | Healthy Social Living |
Primary outcome
Standardized Residual Change in Experiential Avoidance of Suicidal Ideation
Time frame: 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.
Standardized Residual Change in Suicide Risk Severity
Time frame: 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.
1 secondary outcome
Standardized Residual Change in Cognitive Avoidance of Suicidal Ideation
Time frame: Baseline and One week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph Boffa, MS principal investigator
Florida State University
1 site in 1 country: see every site and its status.
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.