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

NCT04414774 | Completed

• 2 other identifiers: EMC-0108-19201912001
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide Ideation

Keywords

Suicide ideation; Mental pain; Mobile app; Application

Outcome Measures

Primary Outcomes (14)

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (2)

• Change from Baseline in Cognitive Fusion Questionnaire (CFQ) at Day 15.

  Baseline and Day 15.

• Change from Day 15 in Cognitive Fusion Questionnaire (CFQ) at Day 30.

  Day 15 and Day 30.

Study Arms (2)

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.

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.

Device: GG-Suicide-Ideation

Interventions

GG-Suicide-Ideation DEVICE

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.

using app first; waiting list

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shahak Yariv: lead
• Interdisciplinary Center Herzliya: collaborator

Study Sites (1)

Emek Medical Center

Afula, 1834111, Israel

Location

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Study Officials

• Sahak Yariv, Doctor

  Emek Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior physician in mental health care and neuromodulation service manager

Model Details: 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.

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: June 4, 2020
• Study Start: June 14, 2020
• Primary Completion: June 15, 2021
• Study Completion: June 15, 2021
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)