Digital Dialectical Behavioral Therapy (d-DBT) Skills for Treatment of Acute Suicidality in Psychiatric Inpatients: Randomized Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Client Satisfaction Questionnaire 8 (CSQ-8)
研究概览
简要总结
Suicidality (ideation about taking one's life, suicide plans, and attempts) is a major public health concern in Ontario and worldwide. Psychiatric inpatients with suicidality represent a group that is high-risk for subsequent suicide. Current standard-care for suicidal psychiatric inpatients focuses on containment of risk and indirect treatment of suicidality by treating any underlying mental disorder. Though there is evidence that addressing suicidality directly is more effective than an indirect approach, there are limited evidence based treatments that target suicidality. Furthermore, there are few high-quality studies that have included inpatients. Psychotherapeutic interventions are under-utilized for inpatients and COVID-19 has further widened this gap given attempts by hospitals to reduce face-to-face contact with patients. Digital psychotherapy interventions have the ability to bridge this gap given their lower cost, ease of dissemination, acceptability by patients, and effectiveness. To our knowledge, there are no studies that have assessed the feasibility, acceptability and effectiveness of digital interventions for suicidal inpatients. Our study is a feasibility trial of a previously studied digital Dialectical Behavioural Therapy (d-DBT) skills intervention in suicidal psychiatric inpatients.
The study is a two arm randomized parallel group-controlled trial, 6-10 day, flexible timeline, randomized feasibility trial of a d-DBT skills intervention added to standard care for patients admitted to psychiatric inpatient units with suicidality. There will be 20 patients who will receive the intervention in addition to standard care and 20 patients who will receive standard care alone. There will also be a 4 week follow-up after discharge from hospital.
Participants will be admitted for psychiatric care at the Complex and Critical Care Units, Centre for Addiction and Mental Health (CAMH), Toronto.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
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
- •patients with any DSM-5 diagnosis aged 18 years and above;
- •admitted to CAMH with suicidality and a baseline BSI score of > 6;
- •capable and willing to give informed consent;
- •anticipated length of admission is greater than 5 days;
- •deemed suitable by the primary team to take part in a psychotherapeutic intervention as part of standard care
- •Capacity to consent will be evaluated by the research staff performing the informed consent process. It will be assessed as the participant's ability to understand and appreciate the risks and benefits of taking part in the proposed study.
排除标准
- •presence of psychiatric symptoms that interfere with the ability to complete the d-DBT
- •Concurrent treatment with ECT or MST
结局指标
主要结局
Client Satisfaction Questionnaire 8 (CSQ-8)
时间窗: 6-10 days
Acceptability - whether the intervention is appropriate for the acute inpatient setting. The CSQ-8 scores range from 8 to 32, with higher values indicating higher satisfaction with the intervention.
User Experience Questionnaire (UXQ)
时间窗: 6-10 days
Usability - whether the intervention is serviceable for its intended purpose. The UXQ has 11 items exploring characteristics informing usability of mobile apps, each scored from 0-10, for a total score ranging from 10-110 (with larger scores indicating increased usability).
Recruitment and retention rates
时间窗: 6-10 days
Feasibility - whether the intervention is possible in the acute inpatient setting
次要结局
- Columbia-Suicide Severity Rating Scale (C-SSRS)(5-10 days in addition to discharge and 4 weeks post-discharge)
- Clinical Global Impression (CGI)(5-10 days in addition to discharge and 4 weeks post-discharge)
- Brief Difficulties in Emotion Regulation Scale (DERS-16)(5-10 days in addition to discharge and 4 weeks post-discharge)
- Kessler psychological distress scale (K10)(5-10 days in addition to discharge and 4 weeks post-discharge)