Anxiety Disorders Clinical Trial
— UMEIIOfficial title:
The Brain´s Plasticity and Change in Cellular Aging After Internet-delivered Cognitive Behavior Therapy for Social Anxiety Disorder
Verified date | August 2017 |
Source | Linkoeping University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study evaluates underlying psychological and biological mediators in Internet-delivered cognitive behavior therapy for adults with social anxiety disorder.
Status | Active, not recruiting |
Enrollment | 50 |
Est. completion date | May 2021 |
Est. primary completion date | April 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
Sweden | Umeå university | Umeå |
Lead Sponsor | Collaborator |
---|---|
Linkoeping University | Karolinska Institutet, Stockholm University, Umeå University, Uppsala University |
Sweden,
Furmark T, Tillfors M, Marteinsdottir I, Fischer H, Pissiota A, Långström B, Fredrikson M. Common changes in cerebral blood flow in patients with social phobia treated with citalopram or cognitive-behavioral therapy. Arch Gen Psychiatry. 2002 May;59(5):425-33. — View Citation
Lindqvist D, Epel ES, Mellon SH, Penninx BW, Révész D, Verhoeven JE, Reus VI, Lin J, Mahan L, Hough CM, Rosser R, Bersani FS, Blackburn EH, Wolkowitz OM. Psychiatric disorders and leukocyte telomere length: Underlying mechanisms linking mental illness with cellular aging. Neurosci Biobehav Rev. 2015 Aug;55:333-64. doi: 10.1016/j.neubiorev.2015.05.007. Epub 2015 May 18. Review. — View Citation
Månsson KN, Carlbring P, Frick A, Engman J, Olsson CJ, Bodlund O, Furmark T, Andersson G. Altered neural correlates of affective processing after internet-delivered cognitive behavior therapy for social anxiety disorder. Psychiatry Res. 2013 Dec 30;214(3):229-37. doi: 10.1016/j.pscychresns.2013.08.012. Epub 2013 Sep 21. — View Citation
Månsson KN, Frick A, Boraxbekk CJ, Marquand AF, Williams SC, Carlbring P, Andersson G, Furmark T. Predicting long-term outcome of Internet-delivered cognitive behavior therapy for social anxiety disorder using fMRI and support vector machine learning. Transl Psychiatry. 2015 Mar 17;5:e530. doi: 10.1038/tp.2015.22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Resting-state fMRI 6 minutes | Salami et al., 2014, PNAS | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | |
Other | Self-referential criticism | Blair et al., 2008, Arch Gen Psych | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | |
Other | Hariri´s Hammer (emotional face perception) | Hariri et al., 2002, Science | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | |
Other | Brain habituation during face perception | Fischer et al., 2003, Brain Research Bulletin | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | |
Other | Diffusion Tensor Imaging (DTI) | Salami et al., 2012, Biochim Biophys Acta | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | |
Other | Leukocyte telomere length | Lindqvist et al., 2015, Neurosci Biobehav Rev | Baseline 1 (week 0), Baseline 2 (week 9), week 20 (post-treatment) | |
Other | Telomere terminal transferase (telomerase) | Wolkowitz et al., 2012, Mol Psychiatry | Baseline 1 (week 0), Baseline 2 (week 9), week 20 (post-treatment) | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | Beck Anxiety Inventory (BAI) | Self reported anxiety symptoms | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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) | |
Secondary | 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 | |
Secondary | Quality of Life (QOLI) | Screening, week 20 (post-treatment), and at 6, 12, and 60 months | ||
Secondary | Social Network Index (SNI) | Bickart et al., 2010, Nat Neurosci | Baseline 1 (week 0) | |
Secondary | Brown Attention-Deficit Disorder Scales (Brown ADD) | Baseline 1 (week 0) | ||
Secondary | 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 | ||
Secondary | Treatment Credibility Scale (TCS) | Baseline 2 (week 9), week 13 during treatment | ||
Secondary | Revised NEO Personality Inventory (NEO-PI-R) | Baseline 1 (week 0) | ||
Secondary | Insomnia Severity Index (ISI) | Baseline 1 (week 0) | ||
Secondary | Karolinska Sleep Questionnaire (KSQ) | Baseline 1 (week 0) | ||
Secondary | State-Trait Anxiety Inventory (STAI-T) | Baseline 1 (week 0) | ||
Secondary | State-Trait Anxiety Inventory (STAI-S) | Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment) | ||
Secondary | MINI International Neuropsychiatric Interview | Swedish version 7.0.0 | Screening |
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