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

NCT02592564 | Unknown

• 1 other identifier: UMESTUDIEN-II
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anxiety Disorders; Social Anxiety Disorder

Keywords

Magnetic Resonance Imaging; Cognitive Behavior Therapy; Telomerase; Telomere Length, Mean Leukocyte

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (19)

• Clinically Global Impression-Severity scale (CGI-S)

  Screening, week 20 (post-treatment), and at 6, 12, and 60 months

• 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

• Social Interaction Anxiety Scale (SIAS)

  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

Other Outcomes (7)

• Resting-state fMRI 6 minutes

  Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)

• Self-referential criticism

  Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)

• Hariri´s Hammer (emotional face perception)

  Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)

Study Arms (1)

Psychological treatment

EXPERIMENTAL

Psychological treatment during 9 weeks.

Behavioral: Internet-delivered cognitive behavior therapy

Interventions

Internet-delivered cognitive behavior therapy BEHAVIORAL

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.

Also known as: Internet-delivered CBT

Psychological treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Social Anxiety Disorder as primary diagnosis (DSM-5)
• Otherwise somatically healthy
• Willingness to participate in a symptom provocation brain imaging trial

You may not qualify if:

• 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)

Sponsors & Collaborators

• Linkoeping University: lead
• Umeå University: collaborator
• Uppsala University: collaborator
• Stockholm University: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Umeå university

Umeå, 90187, Sweden

Location

Related Publications (4)

• 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.

  PMID: 24064198 BACKGROUND

• 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.

  PMID: 25781229 BACKGROUND

• 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.

  PMID: 25999120 BACKGROUND

• 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.

  PMID: 11982446 BACKGROUND

MeSH Terms

Conditions

Anxiety Disorders; Phobia, Social

Condition Hierarchy (Ancestors)

Mental Disorders; Phobic Disorders

Study Officials

• Kristoffer NT Månsson, PhD

  Stockholm University, Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: October 23, 2015
• First Posted: October 30, 2015
• Study Start: October 1, 2015
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2021
• Last Updated: September 1, 2017

Record last verified: 2017-08

Locations

SE (1)