Feasibility and Preliminary Efficacy of the Unified Protocol in a Blended Format for Emotional Disorders in Primary Care: A Pilot Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Feasibility (Recruitment and Retention Rates)
研究概览
简要总结
The goal of this clinical trial is to learn if a "blended" therapy format (combining face-to-face therapy sessions with a smartphone app) works to treat emotional disorders, such as depression and anxiety, in adults. It will also see if this blended format is feasible and acceptable for patients in primary care settings.
The main questions it aims to answer are:
Does the blended therapy format reduce symptoms of depression and anxiety?
Is the blended format as effective as standard face-to-face therapy?
Do participants find the smartphone app easy and helpful to use?
Researchers will compare the blended therapy group to a standard face-to-face therapy group and a wait-list control group to see if the blended approach works well.
Participants will:
Attend therapy sessions based on the Unified Protocol (a type of cognitive-behavioral therapy) for about 10 weeks.
Use a smartphone app to complete exercises and track their emotions (if assigned to the blended group).
Answer questionnaires about their symptoms and quality of life at the beginning, at the end of treatment, and 3 months later.
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
- •Aged between 18 and 65 years.
- •Scoring 8 or higher on the Overall Anxiety Severity and Impairment Scale (OASIS) OR the Overall Depression Severity and Impairment Scale (ODSIS), indicating clinical severity.
- •Ownership of a smartphone (Android or iOS) and ability to use mobile applications.
- •Literacy in Turkish.
- •Willingness to participate in the study and sign the informed consent form.
排除标准
- •Diagnosis of bipolar disorder, psychotic disorder, or antisocial personality disorder (assessed via MINI 5.0.0).
- •High risk of suicide (assessed via MINI 5.0.0).
- •Cognitive impairment (Score < 21 on the Montreal Cognitive Assessment - MoCA).
- •Current substance alcohol or drug dependence.
- •Currently receiving another psychological treatment (psychotherapy).
- •Changes in psychopharmacological treatment (medication dosage or type) within the last 3 months (participants must be on a stable dose).
研究组 & 干预措施
Wait-list Control
Blended UP
干预措施: Unified Protocol (Behavioral)
Face-to-Face UP
干预措施: Unified Protocol (Behavioral)
结局指标
主要结局
Feasibility (Recruitment and Retention Rates)
时间窗: Post-treatment (Week 10)
Feasibility will be evaluated by tracking the recruitment rate (meeting the target of N=45 within the planned timeframe) and the retention rate. A success criterion is defined as ≥80% of participants in the intervention groups completing the study protocol.
Acceptability (Participant Satisfaction)
时间窗: Post-treatment (Week 10)
Assessed using items adapted from Branquinho et al. regarding the perceived usefulness of the intervention and preference for the format. Two key questions are asked: (1) Perceived usefulness (Yes/No) and (2) Preference for this type of treatment (rated on a 4-point scale from "No, I would refuse" to "Yes, I would prefer it"). Qualitative feedback on advantages/disadvantages is also collected.
次要结局
- Change in Overall Anxiety Severity and Impairment Scale (OASIS) Score(Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up)
- Change in Overall Depression Severity and Impairment Scale (ODSIS) Score(Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up)
- Change in Multidimensional Emotional Disorder Inventory (MEDI) Score(Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up)
- Change in Difficulties in Emotion Regulation Scale (DERS) Score(Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up)
- Change in Short Form-12 (SF-12) Quality of Life Score(Baseline (Week 0), Post-treatment (Week 10), and 3-month follow-up)
- Working Alliance Inventory-Short Revised (WAI-SR) Score(Post-treatment (Week 10))
- System Usability Scale (SUS) Score (Note: Only for Blended Group)(Post-treatment (Week 10))
- App Engagement: Duration of Usage (Note: Only for Blended Group)(Through the intervention period (Up to Week 10))
- App Engagement: Videos Viewed (Note: Only for Blended Group)(Through the intervention period (Up to Week 10))
- App Engagement: Completed Exercises (Note: Only for Blended Group)(Through the intervention period (Up to Week 10))
研究者
Merve Demir Budakçıgil
Research Assistant
Aydin Adnan Menderes University