Acceptability, Feasibility and Preliminary Outcomes of the Kiso Mind App for Outpatients With Schizophrenia Spectrum Disorders: A Randomized Controlled Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of PP receiving threshold dose (Acceptability)
研究概览
简要总结
The Kiso pilot study is a randomized controlled trial to test the acceptability and feasibility of a novel digital intervention, namely the Kiso Mind smartphone app. A parallel-group design is utilized. Participants either receive access to the Kiso Mind intervention and treatment-as-usual (TAU) in the experimental condition or receive treatment as usual (TAU) in the control condition. The intervention is designed for participants diagnosed with either schizophrenia (F20.0) or schizoaffective disorder (F25.0) according to the ICD-10.
To examine acceptability, feasibility, and preliminary effectiveness, both self-report and rater-based assessments are administered at baseline (T0) and at the end of the 12-week intervention period (post-intervention T1). Lastly, a qualitative interview will be conducted with participants from the experimental condition. The primary outcome of the present study is the acceptability and feasibility of the Kiso Mind app. The secondary outcome consists of general psychopathology, and positive-, negative-, depressive symptoms, as well as social functioning and self-efficacy ratings.
详细描述
There are multiple ways to join the present study. Healthcare workers at different institutions across Germany identify eligible participants and invite them to participate in the study. Those institutions include inpatient wards and outpatient facilities. Moreover, participants can join via multiple channels, including online channels and advertising such as social media, etc. Eligibility screenings and baseline clinician ratings are conducted centrally by research associates (psychologists) at Charité Universitätsmedizin Berlin via a video interview. After confirming the inclusion criteria, participants will be randomised and receive the self-report section of the baseline assessment. Randomization is conducted independently by research associates at the Universitätsklinikum Hamburg-Eppendorf in Hamburg. After 12 weeks, participants complete a clinical interview to assess the rater-based section of the post-treatment assessment and receive the self-report section via email.
All participant data is stored in a pseudonymized format. No clinical data is saved in combination with clinical data. The participants have the right to access their data and the right to claim deletion of their data. Data are stored in an online database, accessible only to researchers involved in the study.
Due to the exploratory nature of this study, we aim to recruit 60 to 80 participants in total until June.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ICD-10: F20 Schizophrenia, F25 Schizoaffective Disorder
- •Age: 18 - 65 years
- •Sufficient German Language Proficiency
- •Ability to Use a Smartphone
排除标准
- •Intensive Psychotherapy Protocols (more than one psychotherapy session a month)
- •CGI-Score < 3; > 6
- •No smartphone
- •Neurological Disorders or Brain Damage
- •Acute Suicidality
- •Acute Heavy Substance Abuse or Addiction
- •Current Electroconvulsive Therapy
研究组 & 干预措施
Digital Intervention (Kiso Mind App) + TAU.
The intervention comprises a 12-week digital intervention containing several psychoeducation modules as well as a broad variety of evidence-based psychotherapeutic modules based on CBTp principles. In addition, the digital intervention includes functions to assist with daily challenges, such as medication reminders, mood trackers and emergency contacts.
干预措施: Digital: Kiso Mind App (Behavioral)
Treatment as Usual
with Schizophrenia or Schizoaffective Disorder in Germany consists of quarterly psychiatric appointments for psychopharmacological treatment. Psychotherapy is typically limited to one appointment a month, in very rare cases multiple appointments a month.
结局指标
主要结局
Proportion of PP receiving threshold dose (Acceptability)
时间窗: 12 weeks
The proportion of modules completed on average by all participants.
Nr. of pp willing to participate (Feasibility)
时间窗: 12 weeks
The number of eligible participants, that are willing to participate in Kiso (recruitment)
次要结局
- Clinical Global Impression (T0; T1)(12 weeks)
- Social Functioning Scale (SFS) (T0, T1)(12 weeks)
- Patient Global Impression (T0; T1)(12 weeks)
- Community Assessment of Psychic Experiences (CAPE) (T0, T1)(12 weeks)
- Beck Depressions-Inventar (BDI-II) (T0, T1)(12 weeks)
- Brief Symptom Inventory (BSI) (T0, T1)(12 weeks)
- General Self-Efficacy Scale (GSE) (T0, T1)(12 weeks)
- EQ-5D Quality of life questionnaire (T0, T1)(12 weeks)
- Patient Satisfaction Questionnaire (ZUF-8) (T1, Experimental Group)(12 weeks)
- System Usability Scale (SUS) (T1, Experimental Group)(12 weeks)
- Negative Effects Questionnaire (NEQ) (T1, Experimental Group)(12 weeks)
- Medication Adherence Report Scale (MARS-5) (T0, T1)(12 weeks)
研究者
Kerem Böge
Prof. Dr. Dr.
Charite University, Berlin, Germany