- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02592564
Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder (UMEII)
The Brain´s Plasticity and Change in Cellular Aging After Internet-delivered Cognitive Behavior Therapy for Social Anxiety Disorder
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Umeå, Sweden, 90187
- Umea University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Psychological treatment
Psychological treatment during 9 weeks.
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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.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically Global Impression-Improvement scale (CGI-I; Change from baseline)
Time Frame: At week 20 (post-treatment), and at 6, 12, and 60 months
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Clinician administrated telephone-interview to determine the participant´s treatment response rates (very much worse to very much improved)
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At week 20 (post-treatment), and at 6, 12, and 60 months
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Liebowitz Social Anxiety Scale, Self-report version (LSAS-SR; Change from baseline)
Time Frame: 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
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Self reported social anxiety symptoms on fear (scoring 0-3) and avoidance (scoring 0-3) in 24 social situations.
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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
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Clinically Global Impression-Severity scale (CGI-S)
Time Frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Clinician administrated telephone-interview to determine the participant´s severity of illness
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Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Social Phobia Screening Questionnaire (SPSQ)
Time Frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Self reported social anxiety symptoms on distress (scoring 0-4) in 24 social situations.
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Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Beck Anxiety Inventory (BAI)
Time Frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Self reported anxiety symptoms
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Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Social Interaction Anxiety Scale (SIAS)
Time Frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Self reported social anxiety symptoms on distress (scoring 0-4) in 21 social situations.
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Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Social Phobia Scale (SPS)
Time Frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Self reported social anxiety symptoms on distress (scoring 0-4) in 20 social situations.
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Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Montgomery Åsberg Depression Rating Scale, Self-report version (MADRS-S)
Time Frame: Screening, Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
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Self reported depressive symptoms (scoring 0-6).
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Screening, Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
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Subjective unit of discomfort on fear and distress (SUD)
Time Frame: Before experimental tasks while undergoing MRI, at Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Self reported scoring 0-100 on fear and distress separately
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Before experimental tasks while undergoing MRI, at Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Social Probability/Cost Questionnaire
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
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40 items scoring 0 to 8. Foa et al., 1996, J Abnormal Psychology
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Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
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Quality of Life (QOLI)
Time Frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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Social Network Index (SNI)
Time Frame: Baseline 1 (week 0)
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Bickart et al., 2010, Nat Neurosci
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Baseline 1 (week 0)
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Brown Attention-Deficit Disorder Scales (Brown ADD)
Time Frame: Baseline 1 (week 0)
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Baseline 1 (week 0)
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Difficulties in Emotion Regulation Scale (DERS)
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
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Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
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Treatment Credibility Scale (TCS)
Time Frame: Baseline 2 (week 9), week 13 during treatment
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Baseline 2 (week 9), week 13 during treatment
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Revised NEO Personality Inventory (NEO-PI-R)
Time Frame: Baseline 1 (week 0)
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Baseline 1 (week 0)
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Insomnia Severity Index (ISI)
Time Frame: Baseline 1 (week 0)
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Baseline 1 (week 0)
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Karolinska Sleep Questionnaire (KSQ)
Time Frame: Baseline 1 (week 0)
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Baseline 1 (week 0)
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State-Trait Anxiety Inventory (STAI-T)
Time Frame: Baseline 1 (week 0)
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Baseline 1 (week 0)
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State-Trait Anxiety Inventory (STAI-S)
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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MINI International Neuropsychiatric Interview
Time Frame: Screening
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Swedish version 7.0.0
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Screening
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Resting-state fMRI 6 minutes
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Salami et al., 2014, PNAS
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Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Self-referential criticism
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Blair et al., 2008, Arch Gen Psych
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Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Hariri´s Hammer (emotional face perception)
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Hariri et al., 2002, Science
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Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Brain habituation during face perception
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Fischer et al., 2003, Brain Research Bulletin
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Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Diffusion Tensor Imaging (DTI)
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Salami et al., 2012, Biochim Biophys Acta
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Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
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Leukocyte telomere length
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 20 (post-treatment)
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Lindqvist et al., 2015, Neurosci Biobehav Rev
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Baseline 1 (week 0), Baseline 2 (week 9), week 20 (post-treatment)
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Telomere terminal transferase (telomerase)
Time Frame: Baseline 1 (week 0), Baseline 2 (week 9), week 20 (post-treatment)
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Wolkowitz et al., 2012, Mol Psychiatry
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Baseline 1 (week 0), Baseline 2 (week 9), week 20 (post-treatment)
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Kristoffer NT Månsson, PhD, Stockholm University, Karolinska Institutet
Publications and helpful links
General Publications
- Mansson 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(3):e530. doi: 10.1038/tp.2015.22.
- Lindqvist D, Epel ES, Mellon SH, Penninx BW, Revesz 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.
- Mansson 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.
- Furmark T, Tillfors M, Marteinsdottir I, Fischer H, Pissiota A, Langstrom 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. doi: 10.1001/archpsyc.59.5.425.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UMESTUDIEN-II
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