The Brain´s Plasticity and Change in Cellular Aging After Internet-delivered Cognitive Behavior Therapy for Social Anxiety Disorder
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Clinically Global Impression-Improvement scale (CGI-I; Change from baseline)
研究概览
简要总结
This study evaluates underlying psychological and biological mediators in Internet-delivered cognitive behavior therapy for adults with social anxiety disorder.
详细描述
Internet-delivered cognitive behavior therapy for social anxiety disorder has previously demonstrated to target and affect the brain´s fear network, typically neural response in the amygdala ameliorate after effective psychological treatment. Commonly, neuroimaging studies have performed brain imaging at pre- and post-intervention, yet, longitudinal study designs including several repeated measures of neural response over the course of treatment are currently missing in anxiety disorder. In the current study the participants will undergo magnetic resonance imaging (MRI) at four occasion. a) Twice before treatment initiation (9 weeks apart), b) at week 4 (during treatment), c) and directly after treatment termination.
Biological aging can be quantified at the individual cell level by measuring telomere length in peripheral immune cells (leukocytes). Telomeres are located at the end of each chromosome and protect the genetic material during cell division. Telomerase is an enzyme that can lengthen telomeres, and have in this way a protective function against accelerated cellular aging. Variations in these bodily processes have been associated with psychiatric manifestations such as anxiety and depression. In the current study the participant´s telomere length and telomerase activity will be assessed at three occasion. a) Twice before treatment initiation (9 weeks apart), and b) directly after treatment termination.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Social Anxiety Disorder as primary diagnosis (DSM-5)
- •Otherwise somatically healthy
- •Willingness to participate in a symptom provocation brain imaging trial
排除标准
- •Concurrent psychological treatment
- •Treatment of social anxiety within the three months preceding the study
- •Chronic use of prescribed medication that could influence the results (anxiolytic or antidepressant drugs, certain hypnotics or herbs like St Johns Wort)
- •Contraindications for MRI investigation (implants or other metal objects in the body, brain and heart operations)
- •Pregnancy or planned pregnancy during the first 6 months of the study period
- •Postmenopausal women
- •Any neurological disorders
- •Depressive symptoms, as determined by scoring more than 20 on the MADRS questionnaire (self-report version)
- •Suicidal ideation (scoring more than 2) on the self-report version of MADRS, item 9
- •Suicide at moderate risk (MINI v7)
- •Bipolar disorder (MINI v7)
- •Psychotic syndromes (MINI v7)
- •Substance abuse disorders (MINI v7)
- •Alcohol abuse (MINI v7)
- •Any eating disorder (MINI v7)
- •Antisocial personality disorder (MINI v7)
研究组 & 干预措施
Psychological treatment
Psychological treatment during 9 weeks.
干预措施: Internet-delivered cognitive behavior therapy (Behavioral)
结局指标
主要结局
Clinically Global Impression-Improvement scale (CGI-I; Change from baseline)
时间窗: At week 20 (post-treatment), and at 6, 12, and 60 months
Clinician administrated telephone-interview to determine the participant´s treatment response rates (very much worse to very much improved)
Liebowitz Social Anxiety Scale, Self-report version (LSAS-SR; Change from baseline)
时间窗: Screening, Baseline 1 (week 0), Baseline 2 (week 9), weekly during treatment (week 10-19), week 20 (post-treatment), and at 6, 12, and 60 months
Self reported social anxiety symptoms on fear (scoring 0-3) and avoidance (scoring 0-3) in 24 social situations.
次要结局
- Clinically Global Impression-Severity scale (CGI-S)(Screening, week 20 (post-treatment), and at 6, 12, and 60 months)
- Social Phobia Scale (SPS)(Screening, week 20 (post-treatment), and at 6, 12, and 60 months)
- Montgomery Åsberg Depression Rating Scale, Self-report version (MADRS-S)(Screening, Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months)
- Subjective unit of discomfort on fear and distress (SUD)(Before experimental tasks while undergoing MRI, at Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment))
- Brown Attention-Deficit Disorder Scales (Brown ADD)(Baseline 1 (week 0))
- Difficulties in Emotion Regulation Scale (DERS)(Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months)
- Treatment Credibility Scale (TCS)(Baseline 2 (week 9), week 13 during treatment)
- Revised NEO Personality Inventory (NEO-PI-R)(Baseline 1 (week 0))
- Insomnia Severity Index (ISI)(Baseline 1 (week 0))
- State-Trait Anxiety Inventory (STAI-S)(Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment))
- MINI International Neuropsychiatric Interview(Screening)
- Social Interaction Anxiety Scale (SIAS)(Screening, week 20 (post-treatment), and at 6, 12, and 60 months)
- Social Probability/Cost Questionnaire(Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months)
- Quality of Life (QOLI)(Screening, week 20 (post-treatment), and at 6, 12, and 60 months)
- Social Network Index (SNI)(Baseline 1 (week 0))
- Social Phobia Screening Questionnaire (SPSQ)(Screening, week 20 (post-treatment), and at 6, 12, and 60 months)
- Beck Anxiety Inventory (BAI)(Screening, week 20 (post-treatment), and at 6, 12, and 60 months)
- Karolinska Sleep Questionnaire (KSQ)(Baseline 1 (week 0))
- State-Trait Anxiety Inventory (STAI-T)(Baseline 1 (week 0))
研究者
Kristoffer NT Månsson
PhD
Stockholm University