Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder

Study Overview
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Brief Summary
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This study evaluates underlying psychological and biological mediators in Internet-delivered cognitive behavior therapy for adults with social anxiety disorder.

Detailed Description
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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.

Official Title
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The Brain´s Plasticity and Change in Cellular Aging After Internet-delivered Cognitive Behavior Therapy for Social Anxiety Disorder

Conditions
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Anxiety Disorders, Social Anxiety Disorder

Intervention / Treatment
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* Behavioral: Internet-delivered cognitive behavior therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Social Anxiety Disorder as primary diagnosis (DSM-5) Otherwise somatically healthy Willingness to participate in a symptom provocation brain imaging trial Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Psychological treatment<br>Psychological treatment during 9 weeks. | Behavioral: Internet-delivered cognitive behavior therapy<br>* Internet-delivered cognitive behavior therapy for social anxiety disorder. Similar to previous studies in our research group, the treatment will be delivered during 9 weeks. Each week the participant will be introduced to a module containing text material and homework assignments. The participants will receive feedback via text by a clinical psychologist once a week.<br>* Other names: Internet-delivered CBT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Global Impression-Improvement scale (CGI-I; Change from baseline) | Clinician administrated telephone-interview to determine the participant´s treatment response rates (very much worse to very much improved) | At week 20 (post-treatment), and at 6, 12, and 60 months | 
| Liebowitz Social Anxiety Scale, Self-report version (LSAS-SR; Change from baseline) | Self reported social anxiety symptoms on fear (scoring 0-3) and avoidance (scoring 0-3) in 24 social situations. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically Global Impression-Severity scale (CGI-S) | Clinician administrated telephone-interview to determine the participant´s severity of illness | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | 
| Social Phobia Screening Questionnaire (SPSQ) | Self reported social anxiety symptoms on distress (scoring 0-4) in 24 social situations. | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | 
| Beck Anxiety Inventory (BAI) | Self reported anxiety symptoms | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | 
| Social Interaction Anxiety Scale (SIAS) | Self reported social anxiety symptoms on distress (scoring 0-4) in 21 social situations. | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | 
| Social Phobia Scale (SPS) | Self reported social anxiety symptoms on distress (scoring 0-4) in 20 social situations. | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | 
| Montgomery Åsberg Depression Rating Scale, Self-report version (MADRS-S) | Self reported depressive symptoms (scoring 0-6). | 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) | Self reported scoring 0-100 on fear and distress separately | Before experimental tasks while undergoing MRI, at Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | 
| Social Probability/Cost Questionnaire | 40 items scoring 0 to 8. Foa et al., 1996, J Abnormal Psychology | 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) | Bickart et al., 2010, Nat Neurosci | Baseline 1 (week 0) | 
| 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) | 
| Karolinska Sleep Questionnaire (KSQ) |  | Baseline 1 (week 0) | 
| State-Trait Anxiety Inventory (STAI-T) |  | 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 | Swedish version 7.0.0 | Screening | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Magnetic Resonance Imaging, Cognitive Behavior Therapy, Telomerase, Telomere Length, Mean Leukocyte