Suicide IdeationNCT04414774
Assessing the Effectiveness of a CBT-based App in Reducing Suicidal Ideation
A study testing GG-Suicide-Ideation in people with Suicide Ideation, run by Shahak Yariv at 1 site in Israel.
Trial summary
The aim of this study is to empirically assess the utility of GG-Suicide-Ideation (GGSI), a theory-based mobile application for the prevention of suicide ideation. GGSI is based on principles of Cognitive Behavioral Therapy (CBT), which have been found to be an effective treatment for decreasing suicide risk. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Suicide Ideation
- What is being tested?
- GG-Suicide-Ideation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jun 2020to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Hebrew speakers
- Subjects at a low suicide risk only (see note below).
- Patients who suffered from passive suicide ideation in the past two weeks.
- Participants must have a mobile phone capable of supporting the GGSI app.
Who cannot join
- Patients at moderate to high suicide risk, as determined by The Columbia- Suicide Severity Rating Scale (C-SSRC; Posner et al., 2011)
- Patients diagnosed with psychosis or autism, and drug users.
- Patients who are admitted to the ER, or are hospitalized in the psychiatric wards.
- Suicide risk will be determined by The Columbia- Suicide Severity Rating Scale (C-SSRC; Posner et al., 2011). In accordance with this scale, we defined at a low suicide risk patients who have suicide ideation but without a method of execution, suicide intention, or suicide plan. At moderate to high suicide risk we defined patients who indorse suicide ideation with a method of execution and\or suicide intention and\or suicide plan.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessing the Effectiveness of a CBT-based App in Reducing Suicidal Ideation: An Open Randomized Study
The aim of this study is to empirically assess the utility of GG-Suicide-Ideation (GGSI), a theory-based mobile application for the prevention of suicide ideation. GGSI is based on principles of Cognitive Behavioral Therapy (CBT), which have been found to be an effective treatment for decreasing suicide risk.
In this study half of the participants (i.e. the experiment group) will start an immediate use of GGSI for a period of 15 days. The other half of the participants (i.e. the control group) will be 'on hold' during the first 15 days, after which they will commence use of GGSI for an additional 15 days.
Read more
All participants will complete questionnaires regarding suicide ideation and related risk factors three times during the study: at the beginning of the study (baseline), after 15 days from the beginning of study and after 30 days from the beginning of study.
The investigators hypothesized that in the experimental group, after 15 days of using GGSI app there will be a substantial decrease in the level of suicide ideation and associate risk factors, compared to the control group. If this hypothesis is met, the investigators will examine if the decrease in said measures in the experimental group will maintain after 15 days of follow up. In addition, the investigators hypothesized that in the control group there will be a significant decrease in suicide ideation and related risk factors after 15 days of using GGSI.
Read the detailed description
Introduction:
Suicide is a leading cause of death in many countries. One of the major risk factors of suicide is suicide ideation. Different theories describe the developing path and the association between suicide ideation, suicide attempts, and, eventually, suicide. Given the existing continuum between suicide ideation, suicidal behavior, and suicide, an effective suicide prevention strategy may focus on reducing suicide ideation.
Suicide ideation is an expression of distress and is associated with various risk factors. Among risk factors are depression, mental pain, tolerance of mental pain, hopelessness and helplessness, low self-esteem, thwarted belongingness and perceived burdensomeness.
Suicide ideation and cognition: Historical review on the association between cognition and suicide ideation indicates that there are maladaptive thinking patterns ("cognitive distortions") that exist substantially among suicidal individuals, compared to non-suicidal subjects. Furthermore, David Lester, a well-known researcher in the field of suicidality, examined seven theory-based risk factors for suicide behavior and suggested that they may be considered as the maladaptive cognitive distortions which stand in the core of suicide behavior. The risk factors for suicide ideation, which are mentioned in the head of this paper, are very much congruent to those suggested by Lester, and may be considered as part of the maladaptive thinking patterns that form the basis of suicide ideation and behavior.
Cognitive change as an effective intervention for decreasing suicide ideation: One of the renowned treatments which put a great emphasis on changing maladaptive thinking patterns in order to alleviate the psychological pain of the patient is Cognitive Behavioral Therapy (CBT). CBT is an effective treatment for decreasing suicide risk. CBT is based on the theoretical assumption that the way people think about and interpret life events determines their emotional and behavioral responses to those events. This model suggests that cognitive distortions (repeated distortions in thinking and interpreting reality) are imperative to the formation of suicide thoughts and behavior.
Cognitive-behavioral therapies have been found effective for preventing suicide. After coping with the acute suicide crisis, the treatment emphasizes changing maladaptive schemes and thoughts. According to this and to other findings, it can be assumed that cognitive adaptation is a significant change agent in the reduction of suicide ideation and behavior. Furthermore, it can be said that an intervention designed to challenge dysfunctional thoughts and create accessible adaptive thoughts, in areas previously found to predispose suicidal thoughts, can promote the reduction of suicide ideation.
One way to make this kind of intervention accessible to the general public is through an application. Today there is more awareness to the fact that many individuals who require care do not receive treatment. An application may be a possible solution to overcome this clinical gap and alleviate the suffering of individuals with suicide ideation in the general public. Moreover, an application delivered by smartphones has excellent potential to be acceptable by the user due to its availability, low effort expectancy, and high hedonic motivation.
Suicide prevention and mobile applications: The empirical literature shows an increasing number of mobile applications focusing on preventing suicide. Some of the existing apps contain elements that have been found to be effective for suicide prevention. Most of the apps designated for suicidal crisis and contain multiple interventions. Two applications that were empirically assessed failed to show a substantial decrease in suicide ideation following usage. However, it should be noted that these studies employed a small sample size, and therefore lack statistical power.
The current study: The aim of this study is to empirically assess the utility of GG-Suicide-Ideation (GGSI), a theory-based mobile application for the prevention of suicide ideation. GGSI is based on principles of CBT, which have been found to be an effective treatment for suicidality. Particularly GGSI aims to challenge suicidal maladaptive thoughts and to increase accessibility of adaptive thinking patterns in relevant domains. All of this being done by a daily practice which is delivered in a game-like manner. Moreover, GGSI provides a missing element in the domain of suicide prevention apps: as far as the investigators know, there is no app or internet program for suicide prevention, which is delivered in a game-like manner. In addition, GGSI is designated for daily use, as opposed to most apps, which target suicidal crisis periods specifically. Moreover, the format which GGSI is based on was tested on OCD (Obsessive-Compulsive Disorder) symptoms and found effective.
Considering all of the above, the investigators hypothesize that in the experimental group after 15 days of using GGSI app, there will be a substantial decrease in the level of suicide ideation, mental pain, depression and in measures related to suicidal maladaptive thinking patterns (i.e. tolerance of mental pain, hopelessness, helplessness, low self-esteem, thwarted belongingness and perceived burdensomeness) versus the control group which are on hold for GGSI usage. If this hypothesis will be met, the investigators will examine if the decrease in these measures in the experimental group sustain after 15 days of follow up. In addition, the investigators hypothesize that in the control group there will be a significant decrease in the mentioned measures after 15 days of using GGSI.
Methods
Participant: Participation in the study will be offered to all patients present in the adult-depression unit of the outpatient clinic of Medical Center Ha'emek. Participant recruitment will be done by the treating psychiatrist, who will examine the participants suitability for the study by inclusion and exclusion criteria. Participation in the study will be offered to patients as an adjunct to their proposed psychiatric and psychotherapeutic treatment. The study was approved by the IRB committee.
Sample and power analysis: Power analysis was conducted using G*Power. For α = 0.05, the statistical power is 0.80 and the effect size is medium (f=0.25). Hence, 128 subjects are required for the requested analysis, and this number of participants will be recruited.
Study design: Participants will sign a consent form. The course of the study will be explained to all participant. In the experimental group, after filling out the relevant questionnaires, participants will be explained how to download the GGSI app to their mobile phone, and that they will need to use the app once a day for 15 days. In the control group, participants will be explained that they are now filling out questionnaires and in 15 days they will be invited to another meeting to fill out additional questionnaires and receive the app. The research team will contact participants via a phone call at the following time points: first, seven days after they received the app, the research team will remind and encourage the participants to continue using the GGSI app every day. Second, each time filling out questionnaires is needed (except from when participants fill out questionnaires in the outpatient clinic, see above) the research team will call the subjects, conduct a suicide risk assessment according to the Colombia suicide severity rating scale (C-SSRS). They will also ask participants to fill out questionnaires via the app or a link sent to their phone. Third, after the 15 days app usage period, the participants will be asked to remove the GGSI app from their phone.
Suggested Statistical analysis: As been done before in research on an application with similar interface and with similar study design (waiting list control add on), a series of repeated Measure ANOVA with Bonferroni adjustments, will be calculated in order to asses pre-post scores in both study groups.
Ethical considerations:
The aim of GGSI app is to reduce emotional stress. In any case where participants feel that using the app cause them distress, they can stop the usage in any given time. If the participant requires additional assistance or support, that will be provided to them by the research team. Along the study period, in any case where suicide risk immerges from the questionnaire scores or from subject suicide risk assessment or from any complaint done by a participant, an initial assessment will be made. In case of actual suicide risk, the relevant participant will be referred to suicide risk assessment by the clinic staff or to the emergency room, and their treatment will be transferred to Dr. Yariv Shahak, manager of the depression clinic.
Privacy and information security:
When downloading the app, the information needed for registration is the participant's gender and age. The app does not receive accurate information about the location of the mobile device. While subjects use the app, its output is transmitted to a secure server. The information on the server is stored anonymously, and with no identifying details. The app output will be deleted at the end of the study.
- Conditions
- Suicide Ideation
- Being tested
- GG-Suicide-Ideation
- Keywords
- Suicide ideation, Mental pain, Mobile app, Application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GG-Suicide-IdeationDevice
GG-Suicide-Ideation (GGSI) is a mobile application, consisting of 55 stages. The content of each stage is a list of statements representing core themes, that were found in research and clinical practice to be related to suicide ideation. These are, for example, hopelessness, helplessness, thwarted belongingness, perceived burdensomeness, low self-esteem, tolerance of mental pain, and more. On each stage, several statements are presented on screen, one at a time. The statements express adaptive or maladaptive thinking in the specific core theme of that stage. In case the statement is positive and adaptive, the user needs to drag the statement downwards, towards him. In case the statement is negative and maladaptive, the user needs to drag the statement upwards, away from him. The user advances in stages - three stages per day.
| Study group | Role | What they receive |
|---|---|---|
| using app first | Experimental | The experimental group will immediately start using the GGSI app, for a period of 15 days (T1). After 15 days (T2) the experimental group ceases its use of the app. The end of this period is marked T3. The research team will contact the experimental group on T1, T2 and T3 in order to fill out questionnaires regarding suicide ideation and related risk factors. Receives: Device: GG-Suicide-Ideation |
| waiting list | Active comparator | During the first 15 days, the control group is inactive (T1). After 15 days (T2) the control group will start using GGSI app for additional 15 days (T3). Participants will fill questionnaires about suicide ideation and related risk factors three time during the study on: T1, T2 and T3. Receives: Device: GG-Suicide-Ideation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Adult Suicide Ideation Questionnaire (ASIQ) at Day 15.
Frequency of suicide ideation in the past two weeks will be assessed using a self-report questionnaire (Adult Suicide Ideation Questionnaire (ASIQ) ; Reynolds, 1991). The questionnaire contains 25 items. Each item is scored on a scale of 0-6, yielding a total score of between 0-150. Higher score indicates a greater frequency and severity of suicide ideation. Change= (Day 15 score - baseline score).
Measured: Baseline and Day 15.
Change from Day 15 in Adult Suicide Ideation Questionnaire (ASIQ) at Day 30.
Frequency of suicide ideation in the past two weeks will be assessed using a self-report questionnaire (Adult Suicide Ideation Questionnaire (ASIQ) ; Reynolds, 1991). The questionnaire contains 25 items. Each item is scored on a scale of 0-6, yielding a total score of between 0-150. Higher score indicates a greater frequency and severity of suicide ideation. Change= (Day 30 score - Day 15 score).
Measured: Day 15 and Day 30.
Change from Baseline in Quick Inventory of Depressive Symptomatology Questionnaire (QIDS) at Day 15.
Severity of depressive symptoms in the past week will be assessed using a self-report questionnaire (Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16); Rush et al., 2003). The questionnaire contains 16 items. Each item is scored on a scale of 0-3. Higher score indicates a greater number and severity of depressive symptoms. Change= (Day 15 score - baseline score).
Measured: Baseline and Day 15.
Change from Day 15 in Quick Inventory of Depressive Symptomatology Questionnaire (QIDS) at Day 30.
Severity of depressive symptoms in the past week will be assessed using a self-report questionnaire (Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16); Rush et al., 2003). The questionnaire contains 16 items. Each item is scored on a scale of 0-3. Higher score indicates a greater number and severity of depressive symptoms. Change= (Day 30 score - Day 15 score).
Measured: Day 15 and Day 30.
Change from Baseline in Orbach and Mikulincer Mental Pain scale (OMMPI) at Day 15.
The experience of mental pain will be assessed using a self-report questionnaire (OMMPI; Orbach, Mikulincer, Sirota \& Gilboa-Schechtman, 2003). The questionnaire contains 44 items. Each item is scored on a scale of 1-5, yielding a total score of between 44-220. Higher score indicates a higher level of mental pain. Change= (Day 15 score - baseline score).
Measured: Baseline and Day 15.
Change from Day 15 in Orbach and Mikulincer Mental Pain scale (OMMPI) at Day 30.
The experience of mental pain will be assessed using a self-report questionnaire (OMMPI; Orbach, Mikulincer, Sirota \& Gilboa-Schechtman, 2003). The questionnaire contains 44 items. Each item is scored on a scale of 1-5, yielding a total score of between 44-220. Higher score indicates a higher level of mental pain. Change= (Day 30 score - Day 15 score).
Measured: Day 15 and Day 30.
Change from Baseline in Tolerance of Mental Pain Scale (TMPS) at Day 15.
The perceived ability of the individual to tolerate mental pain will be assessed using a self-report questionnaire (TMPS; Orbach, Gilboa-Schechtman, Johan, Mikulincer, 2004). The questionnaire contains 20 items. Each item is scored on a scale of 1-5, yielding a total score of between 20-100. Higher score indicates a greater perceived ability to tolerate mental pain. Change= (Day 15 score - baseline score).
Measured: Baseline and Day 15.
Change from Day 15 in Tolerance of Mental Pain Scale (TMPS) at Day 30.
The perceived ability of the individual to tolerate mental pain will be assessed using a self-report questionnaire (TMPS; Orbach, Gilboa-Schechtman, Johan, Mikulincer, 2004). The questionnaire contains 20 items. Each item is scored on a scale of 1-5, yielding a total score of between 20-100. Higher score indicates a greater perceived ability to tolerate mental pain. Change= (Day 30 score - Day 15 score).
Measured: Day 15 and Day 30.
Change from Baseline in Helplessness, Hopelessness, and Haplessness Scale (HHH) at Day 15.
Hopelessness and helplessness will be assessed by using a self-report questionnaire (Helplessness, Hopelessness, and Haplessness (HHH); Lester,2001). Originally the questionnaire contained three scales: hopelessness, helplessness, and haplessness. In the current study, only the hopelessness and helplessness scales will be used. Each scale contains 10 items, thus 20 items overall. Each item is scored between 1-6, yielding a total score of 20-120. Higher score indicates greater levels of hopelessness and helplessness. Change= (Day 15 score - baseline score).
Measured: Baseline and Day 15.
Change from Day 15 in Helplessness, Hopelessness, and Haplessness Scale (HHH) at Day 30.
Hopelessness and helplessness will be assessed by using a self-report questionnaire (Helplessness, Hopelessness, and Haplessness (HHH); Lester,2001). Originally the questionnaire contained three scales: hopelessness, helplessness, and haplessness. In the current study, only the hopelessness and helplessness scales will be used. Each scale contains 10 items, thus 20 items overall. Each item is scored between 1-6, yielding a total score of 20-120. Higher score indicates greater levels of hopelessness and helplessness. Change= (Day 30 score - Day 15 score).
Measured: Day 15 and Day 30.
Change from Baseline in Rosenberg Self-Esteem Scale (RSES) at Day 15.
Global self-esteem will be assessed using a self-report questionnaire (Rosenberg Self-Esteem Scale (RSES); Rosenberg, 1965). The questionnaire contains 10 items. Each item is scored on a scale of 1-4, yielding a total score of between 10-40. Higher score indicates higher levels of self-esteem. Change= (Day 15 score - baseline score).
Measured: Baseline and Day 15.
Change from Day 15 in Rosenberg Self-Esteem Scale (RSES) at Day 30.
Global self-esteem will be assessed using a self-report questionnaire (Rosenberg Self-Esteem Scale (RSES); Rosenberg, 1965). The questionnaire contains 10 items. Each item is scored on a scale of 1-4, yielding a total score of between 10-40. Higher score indicates higher levels of self-esteem. Change= (Day 30 score - Day 15 score).
Measured: Day 15 and Day 30.
Change from Baseline in Interpersonal Needs Questioner (INQ) at Day 15.
Interpersonal needs will be assessed using a self-report questionnaire (Interpersonal Needs Questioner (INQ); Van Orden, Cukrowicz, Witte, \& Joiner, 2012). The questionnaire contains two scales: Perceived Burdensomeness (PB) and Thwarted Belongingness (TB). The scales contain 6 and 9 items, respectively. Each item is scored between 1-7, yielding a total score of 6-42 for PB, and 9-63 for TB. Higher scores indicate greater levels of perceived burdensomeness and thwarted belonging. Change= (Day 15 score - baseline score).
Measured: Baseline and Day 15.
Change from Day 15 in Interpersonal Needs Questioner (INQ) at Day 30.
Interpersonal needs will be assessed using a self-report questionnaire (Interpersonal Needs Questioner (INQ); Van Orden, Cukrowicz, Witte, \& Joiner, 2012). The questionnaire contains two scales: Perceived Burdensomeness (PB) and Thwarted Belongingness (TB). The scales contain 6 and 9 items, respectively. Each item is scored between 1-7, yielding a total score of 6-42 for PB, and 9-63 for TB. Higher scores indicate greater levels of perceived burdensomeness and thwarted belonging. Change= (Day 30 score - Day 15 score).
Measured: Day 15 and Day 30.
Secondary outcomes (2)
Change from Baseline in Cognitive Fusion Questionnaire (CFQ) at Day 15.
The extent to which a person is entangled in his thoughts and perceives them as unchangeable, will be assessed using a self-report questionnaire (Cognitive Fusion Questionnaire (CFQ); Gillanders et al., 2014). The questionnaire contains 7 items. Each item is scored on a scale of 1-7, yielding a total score of between 1-49. Higher score indicates greater levels of Cognitive fusion. Change= (Day 15 score - baseline score).
Measured: Baseline and Day 15.
Change from Day 15 in Cognitive Fusion Questionnaire (CFQ) at Day 30.
The extent to which a person is entangled in his thoughts and perceives them as unchangeable, will be assessed using a self-report questionnaire (Cognitive Fusion Questionnaire (CFQ); Gillanders et al., 2014). The questionnaire contains 7 items. Each item is scored on a scale of 1-7, yielding a total score of between 1-49. Higher score indicates greater levels of Cognitive fusion. Change= (Day 30 score - Day 15 score).
Measured: Day 15 and Day 30.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start14 Jun 2020
- Primary completion15 Jun 2021
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (41)Papers the sponsor has linked to this study.
- Other trials for Suicide 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 will be randomly assigned to either the control or experimental group. The experimental group will immediately start using the GGSI app, for a period of 15 days (T1), while the control group waits. After 15 days (T2) the experimental group ceases its use of the app. At the same time, the control group will start its 15-days usage of the app. The end of these 15 days is marked T3.
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahak Yariv
- Sponsor type
- University, hospital or other
- Collaborators
- Interdisciplinary Center Herzliya
- Responsible party
- Sponsor-investigator, Shahak Yariv, HaEmek Medical Center, Israel
- Investigators
- Sahak Yariv, Doctor, Principal investigator, Emek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414774
- Sponsor's protocol ID
- EMC-0108-19
- Other IDs
- 201912001
- Status last verified
- Dec 2023
- First submitted
- 20 May 2020
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Andreasson K, Krogh J, Bech P, Frandsen H, Buus N, Stanley B, Kerkhof A, Nordentoft M, Erlangsen A. MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):171. doi: 10.1186/s13063-017-1876-9.
PubMed 28399909Bhar S, Ghahramanlou-Holloway M, Brown G, Beck AT. Self-esteem and suicide ideation in psychiatric outpatients. Suicide Life Threat Behav. 2008 Oct;38(5):511-6. doi: 10.1521/suli.2008.38.5.511.
PubMed 19014303Allen NB. Cognitive therapy of depression. Aaron T Beck, A John Rush, Brian F Shaw, Gary Emery. New York: Guilford Press, 1979. Aust N Z J Psychiatry. 2002 Apr;36(2):275-8. doi: 10.1046/j.1440-1614.2002.t01-5-01015.x. No abstract available.
PubMed 11982561Beck AT, Brown G, Berchick RJ, Stewart BL, Steer RA. Relationship between hopelessness and ultimate suicide: a replication with psychiatric outpatients. Am J Psychiatry. 1990 Feb;147(2):190-5. doi: 10.1176/ajp.147.2.190.
PubMed 2278535Berk, M. S., Henriques, G. R., Warman, D. M., Brown, G. K., & Beck, A. T. (2004). A cognitive therapy intervention for suicide attempters: An overview of the treatment and case examples. Cognitive and Behavioral Practice, 11(3), 265-277.
Brown GK, Beck AT, Steer RA, Grisham JR. Risk factors for suicide in psychiatric outpatients: a 20-year prospective study. J Consult Clin Psychol. 2000 Jun;68(3):371-7.
PubMed 10883553Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
PubMed 16077050Chandrashekar P. Do mental health mobile apps work: evidence and recommendations for designing high-efficacy mental health mobile apps. Mhealth. 2018 Mar 23;4:6. doi: 10.21037/mhealth.2018.03.02. eCollection 2018. No abstract available.
PubMed 29682510Chu C, Buchman-Schmitt JM, Stanley IH, Hom MA, Tucker RP, Hagan CR, Rogers ML, Podlogar MC, Chiurliza B, Ringer FB, Michaels MS, Patros CHG, Joiner TE. The interpersonal theory of suicide: A systematic review and meta-analysis of a decade of cross-national research. Psychol Bull. 2017 Dec;143(12):1313-1345. doi: 10.1037/bul0000123. Epub 2017 Oct 26.
PubMed 29072480DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005 Apr;62(4):409-16. doi: 10.1001/archpsyc.62.4.409.
PubMed 15809408Ducasse D, Holden RR, Boyer L, Artero S, Calati R, Guillaume S, Courtet P, Olie E. Psychological Pain in Suicidality: A Meta-Analysis. J Clin Psychiatry. 2018 May/Jun;79(3):16r10732. doi: 10.4088/JCP.16r10732.
PubMed 28872267Ellis, T. E., & Rutherford, B. (2008). Cognition and Suicide: Two Decades of Progress. International Journal of Cognitive Therapy, 1(1), 47-68.
Garlow SJ, Rosenberg J, Moore JD, Haas AP, Koestner B, Hendin H, Nemeroff CB. Depression, desperation, and suicidal ideation in college students: results from the American Foundation for Suicide Prevention College Screening Project at Emory University. Depress Anxiety. 2008;25(6):482-8. doi: 10.1002/da.20321.
PubMed 17559087Gillanders DT, Bolderston H, Bond FW, Dempster M, Flaxman PE, Campbell L, Kerr S, Tansey L, Noel P, Ferenbach C, Masley S, Roach L, Lloyd J, May L, Clarke S, Remington B. The development and initial validation of the cognitive fusion questionnaire. Behav Ther. 2014 Jan;45(1):83-101. doi: 10.1016/j.beth.2013.09.001. Epub 2013 Sep 18.
PubMed 24411117Jang JM, Park JI, Oh KY, Lee KH, Kim MS, Yoon MS, Ko SH, Cho HC, Chung YC. Predictors of suicidal ideation in a community sample: roles of anger, self-esteem, and depression. Psychiatry Res. 2014 Apr 30;216(1):74-81. doi: 10.1016/j.psychres.2013.12.054. Epub 2014 Jan 9.
PubMed 24507544
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effectiveness of a CBT-based App in Reducing Suicidal Ideation: An Open Randomized Study
- ClinicalTrials.gov ID
- NCT04414774
- Acronym / sponsor ID
- EMC-0108-19
- Conditions
- Suicide Ideation
- Keywords
- Suicide ideation, Mental pain, Mobile app, Application
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Shahak YarivUniversity, hospital or other
- Collaborators
- Interdisciplinary Center Herzliya
- Study start
- 14 Jun 2020 (actual)
- Primary completion
- 15 Jun 2021 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 4 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to empirically assess the utility of GG-Suicide-Ideation (GGSI), a theory-based mobile application for the prevention of suicide ideation. GGSI is based on principles of Cognitive Behavioral Therapy (CBT), which have been found to be an effective treatment for decreasing suicide risk.
In this study half of the participants (i.e. the experiment group) will start an immediate use of GGSI for a period of 15 days. The other half of the participants (i.e. the control group) will be 'on hold' during the first 15 days, after which they will commence use of GGSI for an additional 15 days.
All participants will complete questionnaires regarding suicide ideation and related risk factors three times during the study: at the beginning of the study (baseline), after 15 days from the beginning of study and after 30 days from the beginning of study.
The investigators hypothesized that in the experimental group, after 15 days of using GGSI app there will be a substantial decrease in the level of suicide ideation and associate risk factors, compared to the control group. If this hypothesis is met, the investigators will examine if the decrease in said measures in the experimental group will maintain after 15 days of follow up. In addition, the investigators hypothesized that in the control group there will be a significant decrease in suicide ideation and related risk factors after 15 days of using GGSI.
Detailed description
Introduction:
Suicide is a leading cause of death in many countries. One of the major risk factors of suicide is suicide ideation. Different theories describe the developing path and the association between suicide ideation, suicide attempts, and, eventually, suicide. Given the existing continuum between suicide ideation, suicidal behavior, and suicide, an effective suicide prevention strategy may focus on reducing suicide ideation.
Suicide ideation is an expression of distress and is associated with various risk factors. Among risk factors are depression, mental pain, tolerance of mental pain, hopelessness and helplessness, low self-esteem, thwarted belongingness and perceived burdensomeness.
Suicide ideation and cognition: Historical review on the association between cognition and suicide ideation indicates that there are maladaptive thinking patterns ("cognitive distortions") that exist substantially among suicidal individuals, compared to non-suicidal subjects. Furthermore, David Lester, a well-known researcher in the field of suicidality, examined seven theory-based risk factors for suicide behavior and suggested that they may be considered as the maladaptive cognitive distortions which stand in the core of suicide behavior. The risk factors for suicide ideation, which are mentioned in the head of this paper, are very much congruent to those suggested by Lester, and may be considered as part of the maladaptive thinking patterns that form the basis of suicide ideation and behavior.
Cognitive change as an effective intervention for decreasing suicide ideation: One of the renowned treatments which put a great emphasis on changing maladaptive thinking patterns in order to alleviate the psychological pain of the patient is Cognitive Behavioral Therapy (CBT). CBT is an effective treatment for decreasing suicide risk. CBT is based on the theoretical assumption that the way people think about and interpret life events determines their emotional and behavioral responses to those events. This model suggests that cognitive distortions (repeated distortions in thinking and interpreting reality) are imperative to the formation of suicide thoughts and behavior.
Cognitive-behavioral therapies have been found effective for preventing suicide. After coping with the acute suicide crisis, the treatment emphasizes changing maladaptive schemes and thoughts. According to this and to other findings, it can be assumed that cognitive adaptation is a significant change agent in the reduction of suicide ideation and behavior. Furthermore, it can be said that an intervention designed to challenge dysfunctional thoughts and create accessible adaptive thoughts, in areas previously found to predispose suicidal thoughts, can promote the reduction of suicide ideation.
One way to make this kind of intervention accessible to the general public is through an application. Today there is more awareness to the fact that many individuals who require care do not receive treatment. An application may be a possible solution to overcome this clinical gap and alleviate the suffering of individuals with suicide ideation in the general public. Moreover, an application delivered by smartphones has excellent potential to be acceptable by the user due to its availability, low effort expectancy, and high hedonic motivation.
Suicide prevention and mobile applications: The empirical literature shows an increasing number of mobile applications focusing on preventing suicide. Some of the existing apps contain elements that have been found to be effective for suicide prevention. Most of the apps designated for suicidal crisis and contain multiple interventions. Two applications that were empirically assessed failed to show a substantial decrease in suicide ideation following usage. However, it should be noted that these studies employed a small sample size, and therefore lack statistical power.
The current study: The aim of this study is to empirically assess the utility of GG-Suicide-Ideation (GGSI), a theory-based mobile application for the prevention of suicide ideation. GGSI is based on principles of CBT, which have been found to be an effective treatment for suicidality. Particularly GGSI aims to challenge suicidal maladaptive thoughts and to increase accessibility of adaptive thinking patterns in relevant domains. All of this being done by a daily practice which is delivered in a game-like manner. Moreover, GGSI provides a missing element in the domain of suicide prevention apps: as far as the investigators know, there is no app or internet program for suicide prevention, which is delivered in a game-like manner. In addition, GGSI is designated for daily use, as opposed to most apps, which target suicidal crisis periods specifically. Moreover, the format which GGSI is based on was tested on OCD (Obsessive-Compulsive Disorder) symptoms and found effective.
Considering all of the above, the investigators hypothesize that in the experimental group after 15 days of using GGSI app, there will be a substantial decrease in the level of suicide ideation, mental pain, depression and in measures related to suicidal maladaptive thinking patterns (i.e. tolerance of mental pain, hopelessness, helplessness, low self-esteem, thwarted belongingness and perceived burdensomeness) versus the control group which are on hold for GGSI usage. If this hypothesis will be met, the investigators will examine if the decrease in these measures in the experimental group sustain after 15 days of follow up. In addition, the investigators hypothesize that in the control group there will be a significant decrease in the mentioned measures after 15 days of using GGSI.
Methods
Participant: Participation in the study will be offered to all patients present in the adult-depression unit of the outpatient clinic of Medical Center Ha'emek. Participant recruitment will be done by the treating psychiatrist, who will examine the participants suitability for the study by inclusion and exclusion criteria. Participation in the study will be offered to patients as an adjunct to their proposed psychiatric and psychotherapeutic treatment. The study was approved by the IRB committee.
Sample and power analysis: Power analysis was conducted using G*Power. For α = 0.05, the statistical power is 0.80 and the effect size is medium (f=0.25). Hence, 128 subjects are required for the requested analysis, and this number of participants will be recruited.
Study design: Participants will sign a consent form. The course of the study will be explained to all participant. In the experimental group, after filling out the relevant questionnaires, participants will be explained how to download the GGSI app to their mobile phone, and that they will need to use the app once a day for 15 days. In the control group, participants will be explained that they are now filling out questionnaires and in 15 days they will be invited to another meeting to fill out additional questionnaires and receive the app. The research team will contact participants via a phone call at the following time points: first, seven days after they received the app, the research team will remind and encourage the participants to continue using the GGSI app every day. Second, each time filling out questionnaires is needed (except from when participants fill out questionnaires in the outpatient clinic, see above) the research team will call the subjects, conduct a suicide risk assessment according to the Colombia suicide severity rating scale (C-SSRS). They will also ask participants to fill out questionnaires via the app or a link sent to their phone. Third, after the 15 days app usage period, the participants will be asked to remove the GGSI app from their phone.
Suggested Statistical analysis: As been done before in research on an application with similar interface and with similar study design (waiting list control add on), a series of repeated Measure ANOVA with Bonferroni adjustments, will be calculated in order to asses pre-post scores in both study groups.
Ethical considerations:
The aim of GGSI app is to reduce emotional stress. In any case where participants feel that using the app cause them distress, they can stop the usage in any given time. If the participant requires additional assistance or support, that will be provided to them by the research team. Along the study period, in any case where suicide risk immerges from the questionnaire scores or from subject suicide risk assessment or from any complaint done by a participant, an initial assessment will be made. In case of actual suicide risk, the relevant participant will be referred to suicide risk assessment by the clinic staff or to the emergency room, and their treatment will be transferred to Dr. Yariv Shahak, manager of the depression clinic.
Privacy and information security:
When downloading the app, the information needed for registration is the participant's gender and age. The app does not receive accurate information about the location of the mobile device. While subjects use the app, its output is transmitted to a secure server. The information on the server is stored anonymously, and with no identifying details. The app output will be deleted at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to either the control or experimental group. The experimental group will immediately start using the GGSI app, for a period of 15 days (T1), while the control group waits. After 15 days (T2) the experimental group ceases its use of the app. At the same time, the control group will start its 15-days usage of the app. The end of these 15 days is marked T3.
| Arm | Type | Receives |
|---|---|---|
| using app first | Experimental | Device: GG-Suicide-IdeationThe experimental group will immediately start using the GGSI app, for a period of 15 days (T1). After 15 days (T2) the experimental group ceases its use of the app. The end of this period is marked T3. The research team will contact the experimental group on T1, T2 and T3 in order to fill out questionnaires regarding suicide ideation and related risk factors. |
| waiting list | Active comparator | Device: GG-Suicide-IdeationDuring the first 15 days, the control group is inactive (T1). After 15 days (T2) the control group will start using GGSI app for additional 15 days (T3). Participants will fill questionnaires about suicide ideation and related risk factors three time during the study on: T1, T2 and T3. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Hebrew speakers
- Subjects at a low suicide risk only (see note below).
- Patients who suffered from passive suicide ideation in the past two weeks.
- Participants must have a mobile phone capable of supporting the GGSI app.
Key exclusion criteria (4 listed)
- Patients at moderate to high suicide risk, as determined by The Columbia- Suicide Severity Rating Scale (C-SSRC; Posner et al., 2011)
- Patients diagnosed with psychosis or autism, and drug users.
- Patients who are admitted to the ER, or are hospitalized in the psychiatric wards.
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 |
|---|---|---|
| GG-Suicide-IdeationGG-Suicide-Ideation (GGSI) is a mobile application, consisting of 55 stages. The content of each stage is a list of statements representing core themes, that were found in research and clinical practice to be related to suicide ideation. These are, for example, hopelessness, helplessness, thwarted belongingness, perceived burdensomeness, low self-esteem, tolerance of mental pain, and more. On each stage, several statements are presented on screen, one at a time. The statements express adaptive or maladaptive thinking in the specific core theme of that stage. In case the statement is positive and adaptive, the user needs to drag the statement downwards, towards him. In case the statement is negative and maladaptive, the user needs to drag the statement upwards, away from him. The user advances in stages - three stages per day. | Device | using app first, waiting list |
Primary outcome
Change from Baseline in Adult Suicide Ideation Questionnaire (ASIQ) at Day 15.
Time frame: Baseline and Day 15.
Frequency of suicide ideation in the past two weeks will be assessed using a self-report questionnaire (Adult Suicide Ideation Questionnaire (ASIQ) ; Reynolds, 1991). The questionnaire contains 25 items. Each item is scored on a scale of 0-6, yielding a total score of between 0-150. Higher score indicates a greater frequency and severity of suicide ideation. Change= (Day 15 score - baseline score).
Change from Day 15 in Adult Suicide Ideation Questionnaire (ASIQ) at Day 30.
Time frame: Day 15 and Day 30.
Frequency of suicide ideation in the past two weeks will be assessed using a self-report questionnaire (Adult Suicide Ideation Questionnaire (ASIQ) ; Reynolds, 1991). The questionnaire contains 25 items. Each item is scored on a scale of 0-6, yielding a total score of between 0-150. Higher score indicates a greater frequency and severity of suicide ideation. Change= (Day 30 score - Day 15 score).
Change from Baseline in Quick Inventory of Depressive Symptomatology Questionnaire (QIDS) at Day 15.
Time frame: Baseline and Day 15.
Severity of depressive symptoms in the past week will be assessed using a self-report questionnaire (Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16); Rush et al., 2003). The questionnaire contains 16 items. Each item is scored on a scale of 0-3. Higher score indicates a greater number and severity of depressive symptoms. Change= (Day 15 score - baseline score).
Change from Day 15 in Quick Inventory of Depressive Symptomatology Questionnaire (QIDS) at Day 30.
Time frame: Day 15 and Day 30.
Severity of depressive symptoms in the past week will be assessed using a self-report questionnaire (Quick Inventory of Depressive Symptomatology Self-Report (QIDS-SR16); Rush et al., 2003). The questionnaire contains 16 items. Each item is scored on a scale of 0-3. Higher score indicates a greater number and severity of depressive symptoms. Change= (Day 30 score - Day 15 score).
Change from Baseline in Orbach and Mikulincer Mental Pain scale (OMMPI) at Day 15.
Time frame: Baseline and Day 15.
The experience of mental pain will be assessed using a self-report questionnaire (OMMPI; Orbach, Mikulincer, Sirota \& Gilboa-Schechtman, 2003). The questionnaire contains 44 items. Each item is scored on a scale of 1-5, yielding a total score of between 44-220. Higher score indicates a higher level of mental pain. Change= (Day 15 score - baseline score).
Change from Day 15 in Orbach and Mikulincer Mental Pain scale (OMMPI) at Day 30.
Time frame: Day 15 and Day 30.
The experience of mental pain will be assessed using a self-report questionnaire (OMMPI; Orbach, Mikulincer, Sirota \& Gilboa-Schechtman, 2003). The questionnaire contains 44 items. Each item is scored on a scale of 1-5, yielding a total score of between 44-220. Higher score indicates a higher level of mental pain. Change= (Day 30 score - Day 15 score).
Change from Baseline in Tolerance of Mental Pain Scale (TMPS) at Day 15.
Time frame: Baseline and Day 15.
The perceived ability of the individual to tolerate mental pain will be assessed using a self-report questionnaire (TMPS; Orbach, Gilboa-Schechtman, Johan, Mikulincer, 2004). The questionnaire contains 20 items. Each item is scored on a scale of 1-5, yielding a total score of between 20-100. Higher score indicates a greater perceived ability to tolerate mental pain. Change= (Day 15 score - baseline score).
Change from Day 15 in Tolerance of Mental Pain Scale (TMPS) at Day 30.
Time frame: Day 15 and Day 30.
The perceived ability of the individual to tolerate mental pain will be assessed using a self-report questionnaire (TMPS; Orbach, Gilboa-Schechtman, Johan, Mikulincer, 2004). The questionnaire contains 20 items. Each item is scored on a scale of 1-5, yielding a total score of between 20-100. Higher score indicates a greater perceived ability to tolerate mental pain. Change= (Day 30 score - Day 15 score).
Change from Baseline in Helplessness, Hopelessness, and Haplessness Scale (HHH) at Day 15.
Time frame: Baseline and Day 15.
Hopelessness and helplessness will be assessed by using a self-report questionnaire (Helplessness, Hopelessness, and Haplessness (HHH); Lester,2001). Originally the questionnaire contained three scales: hopelessness, helplessness, and haplessness. In the current study, only the hopelessness and helplessness scales will be used. Each scale contains 10 items, thus 20 items overall. Each item is scored between 1-6, yielding a total score of 20-120. Higher score indicates greater levels of hopelessness and helplessness. Change= (Day 15 score - baseline score).
Change from Day 15 in Helplessness, Hopelessness, and Haplessness Scale (HHH) at Day 30.
Time frame: Day 15 and Day 30.
Hopelessness and helplessness will be assessed by using a self-report questionnaire (Helplessness, Hopelessness, and Haplessness (HHH); Lester,2001). Originally the questionnaire contained three scales: hopelessness, helplessness, and haplessness. In the current study, only the hopelessness and helplessness scales will be used. Each scale contains 10 items, thus 20 items overall. Each item is scored between 1-6, yielding a total score of 20-120. Higher score indicates greater levels of hopelessness and helplessness. Change= (Day 30 score - Day 15 score).
Change from Baseline in Rosenberg Self-Esteem Scale (RSES) at Day 15.
Time frame: Baseline and Day 15.
Global self-esteem will be assessed using a self-report questionnaire (Rosenberg Self-Esteem Scale (RSES); Rosenberg, 1965). The questionnaire contains 10 items. Each item is scored on a scale of 1-4, yielding a total score of between 10-40. Higher score indicates higher levels of self-esteem. Change= (Day 15 score - baseline score).
Change from Day 15 in Rosenberg Self-Esteem Scale (RSES) at Day 30.
Time frame: Day 15 and Day 30.
Global self-esteem will be assessed using a self-report questionnaire (Rosenberg Self-Esteem Scale (RSES); Rosenberg, 1965). The questionnaire contains 10 items. Each item is scored on a scale of 1-4, yielding a total score of between 10-40. Higher score indicates higher levels of self-esteem. Change= (Day 30 score - Day 15 score).
Change from Baseline in Interpersonal Needs Questioner (INQ) at Day 15.
Time frame: Baseline and Day 15.
Interpersonal needs will be assessed using a self-report questionnaire (Interpersonal Needs Questioner (INQ); Van Orden, Cukrowicz, Witte, \& Joiner, 2012). The questionnaire contains two scales: Perceived Burdensomeness (PB) and Thwarted Belongingness (TB). The scales contain 6 and 9 items, respectively. Each item is scored between 1-7, yielding a total score of 6-42 for PB, and 9-63 for TB. Higher scores indicate greater levels of perceived burdensomeness and thwarted belonging. Change= (Day 15 score - baseline score).
Change from Day 15 in Interpersonal Needs Questioner (INQ) at Day 30.
Time frame: Day 15 and Day 30.
Interpersonal needs will be assessed using a self-report questionnaire (Interpersonal Needs Questioner (INQ); Van Orden, Cukrowicz, Witte, \& Joiner, 2012). The questionnaire contains two scales: Perceived Burdensomeness (PB) and Thwarted Belongingness (TB). The scales contain 6 and 9 items, respectively. Each item is scored between 1-7, yielding a total score of 6-42 for PB, and 9-63 for TB. Higher scores indicate greater levels of perceived burdensomeness and thwarted belonging. Change= (Day 30 score - Day 15 score).
2 secondary outcomes
Change from Baseline in Cognitive Fusion Questionnaire (CFQ) at Day 15.
Time frame: Baseline and Day 15.
Change from Day 15 in Cognitive Fusion Questionnaire (CFQ) at Day 30.
Time frame: Day 15 and Day 30.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 28399909Andreasson K, Krogh J, Bech P, Frandsen H, Buus N, Stanley B, Kerkhof A, Nordentoft M, Erlangsen A. MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial. Trials. 2017 Apr 11;18(1):171. doi: 10.1186/s13063-017-1876-9.
- Background: PubMed 19014303Bhar S, Ghahramanlou-Holloway M, Brown G, Beck AT. Self-esteem and suicide ideation in psychiatric outpatients. Suicide Life Threat Behav. 2008 Oct;38(5):511-6. doi: 10.1521/suli.2008.38.5.511.
- Background: PubMed 11982561Allen NB. Cognitive therapy of depression. Aaron T Beck, A John Rush, Brian F Shaw, Gary Emery. New York: Guilford Press, 1979. Aust N Z J Psychiatry. 2002 Apr;36(2):275-8. doi: 10.1046/j.1440-1614.2002.t01-5-01015.x. No abstract available.
- Background: PubMed 2278535Beck AT, Brown G, Berchick RJ, Stewart BL, Steer RA. Relationship between hopelessness and ultimate suicide: a replication with psychiatric outpatients. Am J Psychiatry. 1990 Feb;147(2):190-5. doi: 10.1176/ajp.147.2.190.
- BackgroundBerk, M. S., Henriques, G. R., Warman, D. M., Brown, G. K., & Beck, A. T. (2004). A cognitive therapy intervention for suicide attempters: An overview of the treatment and case examples. Cognitive and Behavioral Practice, 11(3), 265-277.
- Background: PubMed 10883553Brown GK, Beck AT, Steer RA, Grisham JR. Risk factors for suicide in psychiatric outpatients: a 20-year prospective study. J Consult Clin Psychol. 2000 Jun;68(3):371-7.
- Background: PubMed 16077050Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005 Aug 3;294(5):563-70. doi: 10.1001/jama.294.5.563.
- Background: PubMed 29682510Chandrashekar P. Do mental health mobile apps work: evidence and recommendations for designing high-efficacy mental health mobile apps. Mhealth. 2018 Mar 23;4:6. doi: 10.21037/mhealth.2018.03.02. eCollection 2018. No abstract available.
- Background: PubMed 29072480Chu C, Buchman-Schmitt JM, Stanley IH, Hom MA, Tucker RP, Hagan CR, Rogers ML, Podlogar MC, Chiurliza B, Ringer FB, Michaels MS, Patros CHG, Joiner TE. The interpersonal theory of suicide: A systematic review and meta-analysis of a decade of cross-national research. Psychol Bull. 2017 Dec;143(12):1313-1345. doi: 10.1037/bul0000123. Epub 2017 Oct 26.
- Background: PubMed 15809408DeRubeis RJ, Hollon SD, Amsterdam JD, Shelton RC, Young PR, Salomon RM, O'Reardon JP, Lovett ML, Gladis MM, Brown LL, Gallop R. Cognitive therapy vs medications in the treatment of moderate to severe depression. Arch Gen Psychiatry. 2005 Apr;62(4):409-16. doi: 10.1001/archpsyc.62.4.409.
- Background: PubMed 28872267Ducasse D, Holden RR, Boyer L, Artero S, Calati R, Guillaume S, Courtet P, Olie E. Psychological Pain in Suicidality: A Meta-Analysis. J Clin Psychiatry. 2018 May/Jun;79(3):16r10732. doi: 10.4088/JCP.16r10732.
- BackgroundEllis, T. E., & Rutherford, B. (2008). Cognition and Suicide: Two Decades of Progress. International Journal of Cognitive Therapy, 1(1), 47-68.
- 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.
Sahak Yariv, Doctor principal investigator
Emek Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GG-Suicide-Ideation in people with Suicide Ideation, run by Shahak Yariv at 1 site in Israel.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 12 Dec 2023. 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 Israel. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from Baseline in Adult Suicide Ideation Questionnaire (ASIQ) at Day 15. (time frame: Baseline and Day 15.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414774, which also lists 41 linked publications.
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 12 Dec 2023.