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Assessing the Effectiveness of a CBT-based App in Reducing Suicidal Ideation

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ClinicalTrials.gov Identifier: NCT04414774
Recruitment Status : Recruiting
First Posted : June 4, 2020
Last Update Posted : June 23, 2020
Sponsor:
Collaborator:
Interdisciplinary Center Herzliya
Information provided by (Responsible Party):
Shahak Yariv, HaEmek Medical Center, Israel

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Suicide Ideation Device: GG-Suicide-Ideation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Masking Description: There is no masking in this research, since the research team needs to know what stage the subjects are in in order to conduct the study. Due to ethical considerations, the subjects are aware that the purpose of the app is to reduce mental distress and suicidal ideation.
Primary Purpose: Treatment
Official Title: Assessing the Effectiveness of a CBT-based App in Reducing Suicidal Ideation: An Open Randomized Study
Actual Study Start Date : June 14, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
Experimental: using app first
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.
Device: GG-Suicide-Ideation
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.

Active Comparator: waiting list
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.
Device: GG-Suicide-Ideation
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.




Primary Outcome Measures :
  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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).

  12. 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).

  13. 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).

  14. 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).


Secondary Outcome Measures :
  1. Change from Baseline in Cognitive Fusion Questionnaire (CFQ) at Day 15. [ Time Frame: Baseline and 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).

  2. Change from Day 15 in Cognitive Fusion Questionnaire (CFQ) at Day 30. [ Time Frame: Day 15 and 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).



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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04414774


Contacts
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Contact: Ilanit Elbaz Shchory, Doctor 0544923334 drilanitel@gmail.com
Contact: Sahak Yariv, Doctor yariv_sh@clalit.org.il

Locations
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Israel
Emek Medical Center Recruiting
Afula, Israel, 1834111
Contact: Ilanit Elbaz Shchory, Doctor    0544923334    drilanitel@gmail.com   
Contact: Danielle benayaue    0547938571    daniellec2030@gmail.com   
Sponsors and Collaborators
Shahak Yariv
Interdisciplinary Center Herzliya
Investigators
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Principal Investigator: Sahak Yariv, Doctor Emek Medical Center
Publications:
Berk, 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.
Ellis, T. E., & Rutherford, B. (2008). Cognition and Suicide: Two Decades of Progress. International Journal of Cognitive Therapy, 1(1), 47-68.
Lester, D. (2012). The role of irrational thinking in suicidal behavior. Comprehensive Psychology, 1, 12-02.
Orbach, I., Gilboa-Schechtman, E., Johan, M., Mikulincer, M., (2004). Tolerance for Mental Pain Scale. Bar-Ilan University, Ramat-Gan, Israel.
Reynolds, W. (1991). ASIQ, adult suicidal ideation questionnaire: Professional manual. Psychological Assessment Resources, Incorporated.
Rosenberg, M. (1965). Rosenberg self-esteem scale (SES). Society and the adolescent self-image.
Scott, A., & Guo, B. (2012). For which strategies of suicide prevention is there evidence of effectiveness. Denmark: World Health Organization.
W.H.O. Preventing Suicide: A Global Imperative. Luxembourg: World Health Organization (2014).

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Responsible Party: Shahak Yariv, Senior physician in mental health care and neuromodulation service manager, HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier: NCT04414774    
Other Study ID Numbers: EMC-0108-19
201912001 ( Other Identifier: Ministry of Health Israel )
First Posted: June 4, 2020    Key Record Dates
Last Update Posted: June 23, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shahak Yariv, HaEmek Medical Center, Israel:
Suicide ideation
Mental pain
Mobile app
Application
Additional relevant MeSH terms:
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Suicide
Suicidal Ideation
Self-Injurious Behavior
Behavioral Symptoms