An Evaluation of the Effectiveness and Mechanisms of Change of Measurement Based Care for Depressive and Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 89
- 试验地点
- 2
- 主要终点
- Brief Adjustment Scale-6 (BASE-6)
研究概览
简要总结
Although measurement-based care (MBC) is an evidence-based practice with known benefits, it is not always systematically implemented with fidelity. Questions remain regarding MBC's unique added value compared to usual care.
Thus, the goal of this clinical trial is to investigate the implementation outcome, effectiveness, and mechanisms of change of measurement-based care in adult behavioral health. This study implemented MBC in adult ambulatory behavioral health and will test outcomes using a pragmatic randomized control trial within the RE-AIM (Reach, Efficacy, Adoption, Implementation, and Maintenance) framework.
Researchers will compare three groups: 1) the Measurement-based care group, 2) the treatment-as-usual group, and 3) the waitlist control group. Participants will participate in weekly individual psychotherapy sessions for 12 sessions in total.
详细描述
Measurement-based care (MBC) is an evidenced-based practice, involving routine completion of patient-reported outcome measures and collaborative discussions between clinician and client to inform clinical decision-making and facilitate improvement. Despite its known benefits, such as reduced dropout rates and improved treatment outcomes, questions remain regarding MBC's unique effectiveness compared to standard care. Furthermore, mechanisms of change on how MBC actually works in treatment have yet to be fully investigated. Thus, the current study aims to conduct a randomized control trial to evaluate the added value of MBC, by comparing an MBC+psychotherapy group, a psychotherapy-only group, and a waitlist group with no interventions.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary concern and referral reason for seeking psychotherapy are either depressive- or anxiety-related symptoms and/or psychological distress, using minimum scores as follows: PHQ-9 (score > 4), GAD-7 (score > 4), and BASE-6 (score > 18), and
- •being 18 years old or older.
排除标准
- •Severe physical or psychiatric conditions that would hinder the treatment (e.g., clients with acute psychosis, intellectual disability, or neurocognitive disorders who do not have the capacity to undergo informed consent and participate in the study);
- •currently receiving psychotherapy through another source;
- •significant suicidal/homicidal risk that would need immediate intervention;
- •do not have ability complete Patient-Rated Outcome Measures (PROMs) either in person or remotely
研究组 & 干预措施
Measurement-based care group
Measurement-based care group
干预措施: Psychotherapy (Behavioral)
Treatment-as-Usual group
Treatment-as-Usual group
干预措施: Psychotherapy (Behavioral)
Waitlist control group
Waitlist control group
结局指标
主要结局
Brief Adjustment Scale-6 (BASE-6)
时间窗: Completed weekly through study completion, an average of 3 to 4 months
Self-report questionnaire designed to measure general psychological adjustment and functioning of adult-aged individuals Minimum score: 6 Maximum score: 42 A higher score indicates severe difficulty in psychological adaptation and functioning/worse outcome
Patient Health Questionnaire-9 (PHQ-9)
时间窗: Completed weekly through study completion, an average of 3 to 4 months
Evaluate depression symptoms Minimum score: 0 Maximum score: 27 A higher score indicates more severe depression/worse outcome
Generalized Anxiety Disorder-7 (GAD-7)
时间窗: Completed weekly through study completion, an average of 3 to 4 months
evaluate anxiety symptoms Minimum score: 0 Maximum score: 21 A higher score indicates more severe anxiety/worse outcome
次要结局
- World Health Organization Quality of Life-Brief (WHOQOL-BREF)(Pre-post, through study completion, an average of 3 to 4 months)
- Working Alliance Inventory-Short Form Revised (WAI-SR)(Completed monthly, through study completion, an average of 3 to 4 months)
- Vanderbilt Psychotherapy Process Scale - Patient version (VPPS)(Completed every 6 weeks; through study completion, an average of 3 to 4 months)
研究者
Virginia O'Brien
Principal Investigator
Carilion Clinic