Assessing the Effectiveness of a CBT-based App in Reducing Suicidal Ideation
Condition: Suicide Ideation
MeSH terms: Suicide; Suicidal Ideation
Study type: Interventional

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.
    

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.
    

Intervention name(s): GG-Suicide-Ideation
Intervention type(s): Device
Intervention description(s): 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.
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)
Primary purpose: Treatment
Keywords: Suicide ideation; Mental pain; Mobile app; Application