Transdiagnostic Therapy With Metacognitive Therapy Versus Unified Protocol for Patients With Comorbid Anxiety Disorders: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Clinical Severity Rating (CSR): change over time
研究概览
简要总结
The primary goal of this randomized controlled trial is to compare the effectiveness of two transdiagnostic psychological treatments, Metacognitive Therapy (MCT) and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), for patients with complex anxiety.
详细描述
Background:
Anxiety disorders are highly prevalent, impairing quality of life and contributing to substantial economic burden. A large portion of the affected individuals also fulfill the criteria for at least one other anxiety disorder and/or depression. This comorbidity is associated with increased symptom severity and a poorer prognosis. Cognitive-behavioral therapy (CBT) is effective but traditionally relies on a specific manual for every distinct disorder, complicating the management of comorbidity and increasing training needs for therapists. Transdiagnostic therapies target underlying, shared mechanisms across anxiety disorders and depression, and can be used regardless of specific diagnoses. They thereby offer potential for efficient treatment of complex presentations, addressing a wider range of patients' problems with simplified therapist training.
Aims:
The primary aim of the study is to compare the effectiveness of two transdiagnostic therapies, MCT and UP, for patients with comorbid anxiety. Beyond evaluating effectiveness, the project seeks to identify the key factors that drive improvement during treatment. Research questions:
- Are there differences in effect between MCT and UP regarding clinician-rated severity of anxiety and depression diagnoses after treatment?
- Are there differences in effect between MCT and UP regarding patients' self-reported symptoms of anxiety, depression, and functioning after treatment?
- Are there differences in effect between MCT and UP regarding clinician-rated severity of anxiety and depression diagnoses, as well as patients' self-reported symptoms of anxiety, depression, and functioning, at the 1-year follow-up after completed treatment?
- Does improvement occur in patients in the way that the treatment methods (MCT and UP, respectively) are intended to work, according to the presumptive mechanisms of change?
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors conducting diagnostic interviews and clinical severity ratings, at post and follow-up assessments, are blinded to treatment condition and baseline diagnostic status.
Investigators are blinded to treatment condition in the analysis phase.
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
- •Age 18 years or above
- •Ability to read and speak Swedish
- •A principal diagnosis of post-traumatic stress disorder, generalized anxiety disorder, social anxiety disorder, or panic disorder
- •At least one additional comorbid diagnosis (one of the above diagnoses, or obsessive-compulsive disorder, or major depressive disorder)
- •Patients on psychotropic medication must have been on a stable dose (excluding as-needed medication) for at least six weeks prior to treatment initiation
排除标准
- •Current diagnosis of psychosis, bipolar disorder or moderate to severe substance use disorder
- •Medium to high suicide risk
- •Psychiatric, somatic or social problems that require primary intervention other than the treatments offered in the study
- •Concurrent psychological treatment
研究组 & 干预措施
Metacognitive therapy (MCT)
Transdiagnostic MCT, focused on modifying dysfunctional metacognitions and thereby reducing attentional and cognitive processes central to maintaining anxiety disorders.
干预措施: Metacognitive therapy (MCT) (Behavioral)
Unified protocol (UP)
Transdiagnostic cognitive-behavioral therapy, focused on emotion regulation processes central to the development and maintenance of anxiety disorders, particularly neuroticism.
干预措施: Unified protocol (UP) (Behavioral)
结局指标
主要结局
Clinical Severity Rating (CSR): change over time
时间窗: Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up.
Diagnoses are assigned a dimensional clinical severity rating on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or higher representing the clinical threshold for diagnostic criteria. Observer-assessed.
次要结局
- Overall Depression Severity and Impairment Scale (ODSIS): change over time(Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up)
- Overall Anxiety Severity and Impairment Scale (OASIS): change over time(Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up)
- Patient Health Questionnaire-9 (PHQ-9): change over time(Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up)
- Generalized Anxiety Disorder-7 (GAD-7): change over time(Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up)
- Posttraumatic Stress Disorder Checklist-5 (PCL-5): change over time(Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up)
- Penn State Worry Questionnaire (PSWQ): change over time(Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up)
- Liebowitz Social Anxiety Scale-Self-Report (LSAS-SR): change over time(Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up)
- Panic Disorder Severity Scale-Self-Rated (PDSS-SR): change over time(Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1 year follow-up)
- Metacognitions Questionnaire-30 (MCQ-30) - subscale danger and uncontrollability: change over time(Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions))
- Credibility/Expectancy Questionnaire (CEQ): after session 3(After session 3 (between week 3 and 4))
- World Health Organization Disability Assessment Schedule (WHODAS-12): change over time(Baseline, post-treatment (immediately after treatment completion of up to 18 weeks/sessions), 1-year follow-up)
- Difficulties in Emotion Regulation Scale-16 (DERS-16): change over time(Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions))
- Cognitive Attentional Syndrome (CAS-1): change over time(Baseline, weekly during treatment (through up to 18 weeks/sessions) post-treatment (immediately after treatment completion of up to 18 weeks/sessions))
- Facilitative Interpersonal Skills scale for Clients (FIS-C): after session 3(After session 3 (between week 3 and 4))
- Negative Effects Questionnaire (NEQ): after treatment(Post-treatment (immediately after treatment completion of up to 18 weeks/sessions))
- Client Satisfaction Questionnaire (CSQ): after treatment(Post-treatment (immediately after treatment completion of up to 18 weeks/sessions))
研究者
Fredrik Santoft
Lic. psychologist, PhD
Karolinska Institutet