Assessing the Effectiveness of a CBT-based App in Reducing Suicidal Ideation: An Open Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Change from Baseline in Adult Suicide Ideation Questionnaire (ASIQ) at Day 15.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 30 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: GG-Suicide-Ideation (Device)
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.
干预措施: GG-Suicide-Ideation (Device)
结局指标
主要结局
Change from Baseline in Adult Suicide Ideation Questionnaire (ASIQ) at Day 15.
时间窗: 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).
Change from Baseline in Quick Inventory of Depressive Symptomatology Questionnaire (QIDS) at Day 15.
时间窗: 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).
Change from Day 15 in Quick Inventory of Depressive Symptomatology Questionnaire (QIDS) at Day 30.
时间窗: 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).
Change from Baseline in Orbach and Mikulincer Mental Pain scale (OMMPI) at Day 15.
时间窗: 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).
Change from Baseline in Tolerance of Mental Pain Scale (TMPS) at Day 15.
时间窗: 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).
Change from Day 15 in Adult Suicide Ideation Questionnaire (ASIQ) at Day 30.
时间窗: 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).
Change from Day 15 in Tolerance of Mental Pain Scale (TMPS) at Day 30.
时间窗: 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).
Change from Day 15 in Interpersonal Needs Questioner (INQ) at Day 30.
时间窗: 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).
Change from Baseline in Helplessness, Hopelessness, and Haplessness Scale (HHH) at Day 15.
时间窗: 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).
Change from Baseline in Interpersonal Needs Questioner (INQ) at Day 15.
时间窗: 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).
Change from Day 15 in Orbach and Mikulincer Mental Pain scale (OMMPI) at Day 30.
时间窗: 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).
Change from Baseline in Rosenberg Self-Esteem Scale (RSES) at Day 15.
时间窗: 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).
Change from Day 15 in Rosenberg Self-Esteem Scale (RSES) at Day 30.
时间窗: 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).
Change from Day 15 in Helplessness, Hopelessness, and Haplessness Scale (HHH) at Day 30.
时间窗: 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).
次要结局
- Change from Day 15 in Cognitive Fusion Questionnaire (CFQ) at Day 30.(Day 15 and Day 30.)
- Change from Baseline in Cognitive Fusion Questionnaire (CFQ) at Day 15.(Baseline and Day 15.)
研究者
Shahak Yariv
Senior physician in mental health care and neuromodulation service manager
HaEmek Medical Center, Israel