Anxiety Disorders, Social Anxiety Disorder
Conditions
Keywords
Magnetic Resonance Imaging, Cognitive Behavior Therapy, Telomerase, Telomere Length, Mean Leukocyte
Brief summary
This study evaluates underlying psychological and biological mediators in Internet-delivered cognitive behavior therapy for adults with social anxiety disorder.
Detailed description
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.
Interventions
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.
Sponsors
Umeå University
Uppsala University
Stockholm University
Karolinska Institutet
Linkoeping University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Liebowitz Social Anxiety Scale, Self-report version (LSAS-SR; Change from baseline) | 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. |
| Clinically Global Impression-Improvement scale (CGI-I; Change from baseline) | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Baseline 1 (week 0) | — |
| MINI International Neuropsychiatric Interview | Screening | Swedish version 7.0.0 |
| Revised NEO Personality Inventory (NEO-PI-R) | Baseline 1 (week 0) | — |
| 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) | Self reported scoring 0-100 on fear and distress separately |
| 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 | 40 items scoring 0 to 8. Foa et al., 1996, J Abnormal Psychology |
| Quality of Life (QOLI) | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | — |
| Social Network Index (SNI) | Baseline 1 (week 0) | Bickart et al., 2010, Nat Neurosci |
| 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) | — |
| 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 | — |
| Clinically Global Impression-Severity scale (CGI-S) | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | Clinician administrated telephone-interview to determine the participant´s severity of illness |
| Social Phobia Screening Questionnaire (SPSQ) | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | Self reported social anxiety symptoms on distress (scoring 0-4) in 24 social situations. |
| Beck Anxiety Inventory (BAI) | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | Self reported anxiety symptoms |
| Social Interaction Anxiety Scale (SIAS) | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | Self reported social anxiety symptoms on distress (scoring 0-4) in 21 social situations. |
| Social Phobia Scale (SPS) | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | Self reported social anxiety symptoms on distress (scoring 0-4) in 20 social situations. |
| 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 | Self reported depressive symptoms (scoring 0-6). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Self-referential criticism | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | Blair et al., 2008, Arch Gen Psych |
| Hariri´s Hammer (emotional face perception) | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | Hariri et al., 2002, Science |
| Brain habituation during face perception | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | Fischer et al., 2003, Brain Research Bulletin |
| Diffusion Tensor Imaging (DTI) | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | Salami et al., 2012, Biochim Biophys Acta |
| Leukocyte telomere length | Baseline 1 (week 0), Baseline 2 (week 9), week 20 (post-treatment) | Lindqvist et al., 2015, Neurosci Biobehav Rev |
| Resting-state fMRI 6 minutes | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | Salami et al., 2014, PNAS |
| Telomere terminal transferase (telomerase) | Baseline 1 (week 0), Baseline 2 (week 9), week 20 (post-treatment) | Wolkowitz et al., 2012, Mol Psychiatry |
Countries
Sweden
Outcome results
None listed