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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Suicidal Ideation
• Suicide
• Suicide Ideation

• NCT number: NCT04414774
• Study type: Interventional
• Source: HaEmek Medical Center, Israel
• Status: Completed
• Phase: N/A
• Start date: June 14, 2020
• Completion date: June 15, 2021