Feasibility and Potential Efficacy of the PTSD Help App in a Danish PTSD Population: A Randomized Controlled Feasibility Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Randomization ratio
研究概览
简要总结
Due to an increase in PTSD patients seeking treatment in the Danish mental health sector and the addition of Complex PTSD to the ICD-11, there is a need to increase the effectiveness of existing treatments for PTSD. mHealth interventions have been shown to be effective in reducing PTSD symptoms with small to moderate effect sizes. Therefore, the implementation of a mHealth intervention designed for psychiatric PTSD patients as a supplement to therapy may increase treatment outcome. As no studies to date has explored the effects of mHealth interventions in the Danish mental health sector the feasibility and effect of this type of intervention needs testing.
The study's primary hypothesis is that PTSD patients in a Danish psychiatric outpatient setting will want to use a mHealth application as a supplement to care as usual (CAU). The secondary hypothesis is that PTSD patients will benefit from using a mHealth application as a supplement to CAU The study is an investigator-initiated randomized controlled feasibility trial investigating PTSD help combined with CAU compared to CAU for adults with PTSD. Eighty patients will be recruited and receive either the mHealth intervention combined with CAU or CAU alone. Primary outcome is the ratio of eligible patients that agree to participate in the study and the level of user compliance. Secondary outcome data consists of exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, recovery and rumination.
This study may help increase the investigator's knowledge of possible benefits of, as well as potential barriers to, the implementation of mHealth tools. It may also provide a cost-efficient means to increase therapy outcomes and decrease the duration of suffering for PTSD patients in the Danish psychiatric sector.
详细描述
The primary objective for the present randomized controlled feasibility study is to assess the feasibility of using PTSD help in the MHS-CRD to inform a larger future RCT study. The secondary objective is to gather preliminary exploratory data on the effectiveness of PTSD help versus treatment as usual on a range of clinically relevant outcome variables, including exploring C-PTSD as potential moderator.
The study is an investigator-initiated randomized controlled feasibility trial investigating PTSD help combined with CAU compared to CAU for adults with PTSD. The primary outcome is the ratio of eligible patients that agree to participate in the study and do so until the end of the six-week intervention period and user compliance, that is, do the patients actively use the system after randomization, Secondary outcome data consists of exploratory data on PTSD help on PTSD symptom severity, level of psychological distress, sleep quality, dissociation symptoms, therapy readiness, quality of life, disability levels, recovery and rumination. These data will be collected on PTSD help, both as standalone intervention in the six weeks before treatment and as a supplement to treatment during the patients' psychotherapeutic treatment for PTSD. The primary outcome will be assessed continuously by logging the patient's interactions with the application. Secondary outcomes will be assessed prior to randomization and start of PTSD help intervention (week 1), at post PTSD help intervention (week 7) and at the end of psychotherapeutic treatment (week 27-29). The design of this trial has been developed using the SPIRIT 2013 guidelines (Chan et al., 2013).
Participants:
The study will recruit patients referred with PTSD symptoms to the Center for Visitation and Diagnostics (CVD) under the MHS-CRD, with the following inclusion criteria: the patient 1) must be at least 18 years old, 2) fulfil the DSM-5 PTSD diagnosis criteria, 3) be referred to PTSD care package treatment (Danske regioner, pakkeforløb for PTSD, 2017), 4) have access to a smartphone with iOS (version 10 or higher) or Android (version 5.0.1. or higher) and 5) provide informed consent. Exclusion criteria are patients with 1) suicidal risk, 2) ongoing episode of bipolar disease or psychotic disorder 3) current abuse of alcohol or drugs, 4) inability to understand and/or read Danish and 5) concurrent psychiatric or psychological treatment of PTSD outside of MHS-CRD.
Randomization:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Care Provider, 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
- •Must be at least 18 years old.
- •Fulfil the DSM-5 PTSD diagnosis criteria.
- •Be referred to PTSD care package treatment (Danske regioner, pakkeforløb for PTSD, 2017)
- •Have access to a smartphone with iOS (version 10 or higher) or Android (version 5.0.
- •Provide informed consent.
排除标准
- •Suicidal risk
- •Ongoing episode of bipolar disease or psychotic disorder
- •Current abuse of alcohol or drugs
- •Inability to understand and/or read Danish
- •Concurrent psychiatric or psychological treatment of PTSD outside of MHS-CRD.
结局指标
主要结局
Randomization ratio
时间窗: 40 weeks
Ratio of eligible patients that can be randomized
compliance with intervention
时间窗: 34 weeks
Fraction of patients that used the intervention continously until the end of the study
次要结局
- Dissociative Symptoms Scale(1 week)
- the Symptom Checklist-10(2 weeks)
- WHO-5(2 weeks)
- INSPIRE(2 weeks)
- The University of Rhode Island Change Assessment Short version(40 weeks)
- Negative Events and Results of Psychological Treatment - Revised(40 weeks)
- the user satisfaction questionnaire(40 weeks)
- Sleep Condition Indicator(1 month)
- PTSD Checklist for DSM-V(1 month)
研究者
Lisa Riisager
Project manager
Mental Health Services in the Capital Region, Denmark