Pilot Randomized Controlled Trial of the Mobile Intervention for Suicidal Thoughts
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Number of participants recruited
研究概览
简要总结
One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions that been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.
详细描述
One of the factors that contributes to suicide risk is what is known as a "suicidal belief system." This belief system is made up of several cognitions, including hopelessness, thwarted belongingness, perceived burdensomeness, unlovability, unbearability, and unsolvability. These cognitions have all been associated with suicide risk among military personnel. Modification of these cognitions may reduce suicidal thoughts and behaviors. The study team has developed a brief mobile intervention entitled the Mobile Intervention for Suicidal Thoughts (MIST) that uses evidence-based interpretation bias modification techniques to reduce these suicide cognitions. The goal of this project is to is to conduct a pilot trial of the MIST intervention to evaluate whether it is feasible an acceptable as an adjunct treatment for Veterans with suicidal ideation.
The investigators will conduct a pilot randomized controlled trial (RCT), in which 50 Veterans with suicidal ideation will be randomized to either MIST plus Treatment as Usual and Safety Planning versus Treatment as Usual and Safety Planning. The central hypothesis is that Veterans will find MIST acceptable and will be willing to use it to reduce their suicidal thoughts.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The investigator and outcomes assessors will be blinded to the participant condition.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Veterans using the Durham VA Health Care System
- •Endorsing suicidal ideation without intent in the last 30 days, established via Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Meet at least every 4 months with a mental health provider, established via chart review chart
- •Can read at least 6th grade level material, established by their demonstrated ability to read the consent form and answer basic questions about it
排除标准
- •Currently in a period of active psychosis or mania, established via the Structured Clinical Interview for DSM-5 (SCID-5)
- •Currently meeting criteria for a moderate or severe alcohol or substance use disorder, established via the SCID-5
- •Endorsing suicidal intent, established via Columbia-Suicide Severity Rating Scale (C-SSRS)
- •Exhibit current prominent suicidal or homicidal ideation requiring immediate intervention
- •Have used the Mobile Intervention for Suicidal Thoughts (MIST) intervention before as part of another research study
研究组 & 干预措施
Safety planning and treatment as usual
Participants will get a safety plan and treatment as usual.
干预措施: Safety planning (Behavioral)
Safety planning, treatment as usual, and Mobile Intervention for Suicidal Thoughts (MIST)
Participants will get a safety plan, treatment as usual, and the MIST intervention.
干预措施: Safety planning (Behavioral)
Safety planning, treatment as usual, and Mobile Intervention for Suicidal Thoughts (MIST)
Participants will get a safety plan, treatment as usual, and the MIST intervention.
干预措施: MIST Intervention (Behavioral)
Safety planning, treatment as usual, and Mobile Intervention for Suicidal Thoughts (MIST)
Participants will get a safety plan, treatment as usual, and the MIST intervention.
干预措施: Treatment as usual (Behavioral)
Safety planning and treatment as usual
Participants will get a safety plan and treatment as usual.
干预措施: Treatment as usual (Behavioral)
结局指标
主要结局
Number of participants recruited
时间窗: Through study completion (approximately 18 months)
Participant feasibility goal will be met if recruitment is 75% or greater of recruitment expectation.
Percentage of enrolled participants who complete the study intervention
时间窗: Post-treatment visit (approximately one month after enrollment)
Treatment retention feasibility goal will be met if attrition is no more than 25%.
Patient satisfaction for MIST app: Client Satisfaction Questionnaire
时间窗: Post-treatment visit (approximately one month after enrollment)
Patient satisfaction will be assessed with item #7 from the Client Satisfaction Questionnaire. This item is scored on a scale of 1 to 4, with one indicating lower satisfaction and 4 indicating greater satisfaction. The patient satisfaction goal will be met if 80% or greater of participants indicate score a 3 or 4 on this item.
MIST intervention utilization
时间窗: Post-MIST assessment visit (approximately one month after enrollment)
MIST utilization goal will be met if MIST app utilization rates are greater than 50% of expected use.
次要结局
未报告次要终点