An Internet-delivered Rumination Focus Cognitive Behavior Therapy in Romania
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Rumination Response Scale -10 items (RRS10)
研究概览
简要总结
- To investigate the efficacy and acceptability of a guided internet-delivered transdiagnostic intervention targeting repetitive negative thinking for individuals with elevated levels of depression and generalized anxiety disorder (mild to moderate clinical symptoms) vs a wait-list control group (WLCG).
- To investigate the hypothesized mechanism of change: Repetitive negative thinking is reduced first, and consequently the clinical symptoms (depression and/or anxiety) decrease.
详细描述
The effectiveness of a Rumination Focused Cognitive-Behavioral Treatment (RF-CBT) will be compared with a wait list control group using a randomized control trial (RCT) design in a culture where this has not been tested before. The treatment approach was design to specifically target repetitive negative thinking (e.g., rumination and worries). Specifically, the treatment involves first a functional analysis design to help participants identify when rumination starts, distinguish between helpful versus unhelpful repetitive thinking, and learn more functional responses, and experiential and imagery exercises design to help them shift their thought processing towards concreteness, absorption and compassion. The main goal of the study is to test the effectiveness of this transdiagnostic approach in reducing symptom of depression and anxiety.
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,
- •display elevated levels of worry and/or rumination (e.g., at least one self-report score above the following cut-offs: Penn State Worry Questionnaire Total score > 50 and/or Rumination Response Scale - Brooding sub-scale ≥ 10)
- •have at least a clinical diagnosis of major depressive disorder/dysthymia, and/or generalized anxiety disorder, and/or social anxiety disorder, and/or panic disorder, or any combination of these conditions on Structured Clinical Interview for the Diagnostic and Statistical Manual for Mental Disorders (SCID-I)
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.);
- •have a primary diagnostic of Post-Traumatic Stress Disorder and/or Obsessive Compulsive Disorder
研究组 & 干预措施
Wait List Control Group
This arm represents the wait-list comparison group.
Rumination-Focused CBT (RFCBT)
RFCBT seeks to change the process of thinking as opposed to the content of thoughts as in standard CBT. The underlying idea is that shifting individuals repetitive negative thinking into the concrete mode will reduce unconstructive ruminations and worries.
干预措施: Rumination-Focused CBT (RFCBT) (Behavioral)
结局指标
主要结局
Rumination Response Scale -10 items (RRS10)
时间窗: Absolute values (average score) of RRS10 subscales (Reflection and Brooding) at 8 weeks (post-intervention)
The Rumination Response Scale -10 items (RRS10) was designed to measure participant's level of rumination. The scale has two subscale: Reflection (5 items) and Brooding (5 items). The score for each subscale ranges from 5 to 20, while the total score ranges from 10 to 40. Low scores are associated with low levels of rumination, while high scores are associated with high levels of rumination.
Patient Health Questionnaire 9 (PHQ9)
时间窗: Absolute values (average score) of PHQ9 at 8 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.
Anxiety Sensitivity Index 16 (ASI16)
时间窗: Absolute values (average score) of ASI at 8 weeks (post-intervention)
ASI16 was designed to measure participant's level of anxiety sensitivity. The scale is unidimensional and the total score ranges from 0 to 64. Low scores are associated with low levels of anxiety sensitivity, while high scores are associated with high levels of anxiety sensitivity.
Generalized Anxiety Disorder 7 (GAD7)
时间窗: Absolute values (average score) of GAD7 at 8 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.
Perseverative Thinking Questionnaire (PTQ)
时间窗: Absolute values (average score) of PTQ at 8 weeks (post-intervention)
Perseverative Thinking Questionnaire (PTQ) was designed to measure participant's level of rumination. The scale is unidimensional and the total score ranges from 0 to 60. Low scores are associated with low levels of rumination, while high scores are associated with high levels of rumination.
Social Phobia Inventory (SPIN)
时间窗: Absolute values (average score) of SPIN at 8 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.
次要结局
- Work and Social Adjustment Scale (WSAS)(Absolute values (average score) of WSAS at 8 weeks (post-intervention))
- Beck Depression Inventory-II (BDI-II)(Absolute values (average score) of BDI-II at 8 weeks (post-intervention))
- Penn State Worry Questionnaire (PSWQ)(Absolute values (average score) of PSWQ at 8 weeks (post-intervention))