RECOVERY: An Internet-delivered Transdiagnostic Cognitive Behavior Therapy in Romania
试验速览
- 阶段
- 不适用
- 入组人数
- 260
- 试验地点
- 2
- 主要终点
- Generalized Anxiety Disorder 7 (GAD7)
研究概览
简要总结
To investigate the efficacy and acceptability of a guided internet delivered transdiagnostic intervention, targeting mild to moderate clinical symptoms of anxiety and depression and emphasizing the changes taking place at the level of the structures of the self.
详细描述
The effectiveness of a Transdiagnostic Cognitive-Behavioral Treatment will be compared with an improved version of it, in which new intervention techniques were added, pointing out the importance of improving some self-concept dimensions in reducing symptoms of anxiety and depression. In order to prove this, the study design will include two active intervention groups; a standard transdiagnostic intervention protocol will be delivered to one group and an improved version of the same transdiagnostic protocol will be delivered to the other group. The new added techniques targets some self-concepts, namely self-compassion, unconditional self-acceptance and self-esteem. The main goal of the study is to concurrently test effectiveness of these two transdiagnostic approaches in reducing symptoms of anxiety and depression and improving the above-mentioned self-concepts. This non-inferiority trial has the power to detect an effect size larger than Cohen's d = .40 (including 20% attrition at post-test and 6 month follow-up)
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
- Single (Outcomes Assessor)
盲法说明
Folow-up interviews will be carried out by a different team of assessors (blinded to the treatment condition)
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
- •be fluent in Romanian,
- •be at least 18 years of age,
- •have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, panic anxiety disorder and/or Agoraphobia, specific phobia or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders 5 (SCID-I 5)
排除标准
- •suicidal plans,
- •changes in the dosage if psychotropic medication during the last month (if present),
- •have bipolar disorder or psychosis (according to medication status),
- •have an alcohol/substance abuse and/or dependence disorder,
- •currently take part in other psychological treatment,
- •obvious obstacle to participation (i.e., no current Internet access, long travel plans during the treatment period etc.)
结局指标
主要结局
Generalized Anxiety Disorder 7 (GAD7)
时间窗: Absolute values (average score) of GAD7 at 10 weeks (post-intervention)
Generalized Anxiety Disorder 7 (GAD7) was designed to measure participant's level of generalized anxiety or worry. The scale is unidimensional and the total score ranges from 0 to 21. Low scores are associated with low levels of worry, while high scores are associated with high levels of worry.
Social Phobia Inventory (SPIN)
时间窗: Absolute values (average score) of SPIN at 10 weeks (post-intervention)
The SPIN was designed to measure participant's level of social phobia. The scale is unidimensional and the total score ranges from 0 to 68. Low scores are associated with low levels of social phobia, while high scores are associated with high levels of social phobia.
Patient Health Questionnaire 9 (PHQ9)
时间窗: Absolute values (average score) of PHQ9 at 10 weeks (post-intervention)
The Patient Health Questionnaire 9 (PHQ9) was designed to measure participant's level of depression. The scale is unidimensional and the total score ranges from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.
Panic Disorder Severity Scale-Self Report (PDSS-SR)
时间窗: Absolute values (average score) of PDSS-SR at 10 weeks (post-intervention)
The PDSS-SR was designed to measure participant's level of panic. The scale is unidimensional and the total score rages from 0 to 28. Low scores are associated with low levels of panic, while high scores are associated with high levels of panic.
次要结局
- New General Self-Efficacy Scale (NGSE)(Absolute values (average score) of NGSE at 10 weeks (post-intervention))
- Work and Social Adjustment Scale (WSAS)(Absolute values (average score) of WSAS at 10 weeks (post-intervention))
- Penn State Worry Questionnaire (PSWQ)(Absolute values (average score) of PSWQ at 10 weeks (post-intervention))
- Anxiety Sensitivity Index 16 (ASI16)(Absolute values (average score) of ASI at 10 weeks (post-intervention))
- Self-Concept Clarity Scale (SCCS)(Absolute values (average score) of SCCS at 10 weeks (post-intervention))
- Beck Depression Inventory-II (BDI-II)(Absolute values (average score) of BDI-II at 10 weeks (post-intervention))
- Rosenberg Self-Esteem Scale (RSES)(Absolute values (average score) of RSES at 10 weeks (post-intervention))
- Overall Anxiety Severity and Impairment Scale (OASIS)(Absolute values (average score) of OASIS at 10 weeks (post-intervention))
- Unconditional Self-Acceptance Questionnaire (USAQ)(Absolute values (average score) of USAQ at 10 weeks (post-intervention))
- Overall Depression Severity and Impairment Scale (ODSIS)(Absolute values (average score) of ODSIS at 10 weeks (post-intervention))
- Self-Compassion Scale (SCS)(Absolute values (average score) of SCS at 10 weeks (post-intervention))
- Minnesota Multiphasic Personality Inventory 2 Neagtive Treatment Indicator Scale (MMPI2TRT)(Absolute values (average score) of MMPI2TRT at 10 weeks (post-intervention))
- Personality Clinical Form - Neagtive TReaTment Indicator Scale (PCFTRT)(Absolute values (average score) of PCFTRT at 10 weeks (post-intervention))