Feasibility Evaluation of a Monitored Self-guided Digital Cognitive Behavioural Therapy Format: an Uncontrolled Trial of a Problem Solving Intervention for Depression and Anxiety
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Treatment Credibility Scale
研究概览
简要总结
The purpose of the study is to evaluate the feasibility of a new monitored self-guided digital cognitive behavioural therapy format through one of the key components of an intervention for depression and anxiety (Problem Solving) and to answer the question: Do patients with significant levels of depression and/or anxiety symptoms consider the monitored self-guided digital format usable and credible? An uncontrolled trial will explore participant's usability and treatment credibility ratings.
详细描述
Objective. The purpose of the study is to evaluate the feasibility of a new monitored self-guided digital cognitive behavioural therapy format through one of the key components of an intervention for depression and anxiety (Problem Solving) and to answer the question: Do patients with significant levels of depression and/or anxiety symptoms consider the monitored self-guided digital format usable and credible?
Background. Problem Solving is a behavioral modification intervention focusing on the training of adaptive problem-solving skills in order to cope more effectively with everyday stressful events. It is one of the most well-examined therapeutic interventions for depression, with reliable support regarding symptom improvement in depression traditionally delivered with therapist-guidance when administered via the Internet. Since a new monitored self-guided digital intervention for depression and anxiety has been developed, including the key component Problem Solving, it is of importance to assess both the usability and treatment-credibility of this format to evaluate if it is feasible.
Methodology. Based on similar feasibility studies including around ten participants, a number of 16-30 participants will be included in this study to compensate for potential drop-outs. Participants will be recruited via a psychiatric clinic belonging to Stockholm County Council in Stockholm, Sweden, and will be patients in queue for treatment for depression and/or anxiety in a psychiatric setting. Inclusion criteria will be significant depression and/or anxiety symptoms. The participants included in the study will access the key component Problem Solving during four weeks while being on waitlist for regular treatment. They will be introduced to the intervention as a self-explanatory tool with possible beneficial effects on depression symptoms. Self-assessments will be carried out during the intervention. The scores on these scales will be compared to available published data from these scales from evaluations of therapist-guided Internet-based interventions if available, and otherwise data from these scales from studies on other digital interventions for mental health. The participants will also answer questions concerning their experience of the format.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Significant depression and/or anxiety symptoms measured with Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder (GAD-7) (i.e. a PHQ-9 and/or GAD-7 score of ≥5).
排除标准
- •insufficient Swedish knowledge
- •minor (i.e. age <18 years)
- •high suicide risk (i.e. a score ≥4 on the ninth item on the Montgomery Åsberg Depression Scale, MADRS-S)
- •lack of access to a device with Internet connection (e.g. computer, mobile, tablet)
- •lack of access to a phone on which calls and SMS can be received
- •psychiatric or somatic problems that must be prioritized before or become an excessive obstacle to the intervention.
结局指标
主要结局
Treatment Credibility Scale
时间窗: immediately after the intervention
Self-rated assessment of treatment credibility, higher score is better
System Usability Scale
时间窗: immediately after the intervention
Self-rated assessment of usability, higher score is better
次要结局
- System Usability Scale(During the intervention: 2 weeks from baseline)
- Negative Effects Questionnaire(During the intervention: 2 weeks from baseline)
- Patient Health Questionnaire - 9(Change from baseline immediately after the intervention)
- Generalized Anxiety Disorder - 7(Change from baseline immediately after the intervention)
- Treatment Credibility Scale(During the intervention: 2 weeks from baseline)
研究者
Martin Kraepelien
Licensed clinical psychologist, Principal investigator, PhD
Karolinska Institutet