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

Suicide Ideation Clinical Trial

Official title:

Assessing the Effectiveness of a CBT-based App in Reducing Suicidal Ideation: An Open Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04414774
• Other study ID #: EMC-0108-19
• Secondary ID: 201912001
• Status: Completed
• Phase: N/A
• Start date: June 14, 2020
• Est. completion date: June 15, 2021

Study information

• Verified date: December 2023
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: June 15, 2021
• Est. primary completion date: June 15, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Ideation

Intervention

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.

Locations

Country	Name	City	State
Israel	Emek Medical Center	Afula

Sponsors (2)

Lead Sponsor	Collaborator
Shahak Yariv	Interdisciplinary Center Herzliya

Country where clinical trial is conducted

Israel, 

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Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline and Day 15.
Primary	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).	Day 15 and Day 30.
Primary	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).	Baseline and Day 15.
Primary	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).	Day 15 and Day 30.
Primary	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).	Baseline and Day 15.
Primary	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).	Day 15 and Day 30.
Primary	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).	Baseline and Day 15.
Primary	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).	Day 15 and Day 30.
Primary	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).	Baseline and Day 15.
Primary	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).	Day 15 and Day 30.
Primary	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).	Baseline and Day 15.
Primary	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).	Day 15 and Day 30.
Primary	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).	Baseline and Day 15.
Primary	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).	Day 15 and Day 30.
Secondary	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).	Baseline and Day 15.
Secondary	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).	Day 15 and Day 30.