Social Phobia and Evasiveness: A Feasibility, Superiority, Randomized Clinical Trial of the Effect of Modified Collaborative Assessment VS Standard Assessment on Patient's Readiness For Psychotherapy (CO-ASSM-RCT)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- University of Rhode Island Change Assessment Scale (URICA)
研究概览
简要总结
The present study wish to compare the preliminarily effects and feasibility of Modified Collaborative Assessment (MCA) - a novel therapeutic approach to diagnostic assessment - with assessment-as-usual among patients with evasiveness as a core psychopathological feature in a randomised controlled study design.
详细描述
The present study wish to compare the preliminarily effects and feasibility of Modified Collaborative Assessment (MCA) - a novel therapeutic approach to diagnostic assessment - with assessment-as-usual (AAU) among patients with evasiveness as a core psychopathological feature in a randomised controlled study design.
The study will include and randomise 42 patients 1:1 to either MCA or AAU, which will be administered as a pre-treatment to the standard psychotherapeutic intervention they will receive in the psychotherapeutic clinic.
MCA will utilize standardised psychological tests administered in collaboration with the patients, in order to thorough diagnose the included patients. The tests available will be the Present State Examination (PSE), the Structured Clinical Interview for DSM-5 Personality Disorders (SCID-5-PD), the Screen for Cognitive Impairment in Psychiatry (SCIP), the Autism Diagnostic Observation Schedule (ADOS-2), the Examination of anomalous self-experience (EASE), the Wechsler Adult Intelligence Scale (WAIS-IV), the Level of Personality Functioning - Brief Form 2.0 (LPFS-BF), the Personality Inventory for DSM-5, 36 item version (PID-36) and the Conners´ Adult ADHD Rating Scales (CAARS).
Data are gathered through a number of questionnaires from patients prior to randomization (T0), at end of MCA (T1) and after four weeks of psychotherapy (T2) - absolute time depend on clinical logistics and timing of group therapy onset.
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
盲法说明
Masking will be applied in the data analysis process
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
- •A tentative ICD-10 diagnosis of either SAD or EPD
- •Going to be offered treatment in the psychiatric community clinics in Naestved, Maribo or Slagelse
排除标准
- •Severe physical health problems.
- •Lack of spoken and written danish corresponding to 9th grade primary school.
- •Eating disorder with BMI < 18
- •Psychotic illness
- •Active diagnosis of substance abuse
研究组 & 干预措施
Modified Collaborative Assessment (MCA)
The patients allocated to this arm will receive assessment inspired by therapeutic/collaborative assessment, as a pre-treatment to the standard psychotherapeutic treatment they will receive in the clinic.
干预措施: Modified Collaborative Assessment (MCA) (Behavioral)
Assessment as usual (AAU)
The patients allocated to this arm will receive standard assessment offered in the clinic, before proceeding to the standard psychotherapeutic treatment they will receive in the clinic.
干预措施: Assessment as Usual (AAU) (Behavioral)
结局指标
主要结局
University of Rhode Island Change Assessment Scale (URICA)
时间窗: Baseline T0 (Week 1 after allocation) and T1 (end of intervention, an average of four weeks after allocation)
The URICA is a 32-item self-report measure that includes 4 subscales measuring the motivation for change: Precontemplation, Contemplation, Action, and Maintenance. The minimum score is 32 and maximum value is 160. A higher score indicate that the patient is more ready to making changes in their life, compared to a lower.
次要结局
- Liebowitz Social Anxiety Scale-Self- Report (LSAS)(Baseline T0 (Week 1 after allocation); T1 (end of intervention, an average of four weeks after allocation) and T2 (after one month psychotherapy))
研究者
Sidse Arnfred
Professor, senior consultant, MD MSc PHD DMSC
Psychiatric Research Unit, Region Zealand, Denmark