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

Anxiety Disorders Clinical Trial

— UMEII  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02592564
• Other study ID #: UMESTUDIEN-II
• Status: Active, not recruiting
• Phase: N/A
• First received: October 23, 2015
• Last updated: August 31, 2017
• Start date: October 2015
• Est. completion date: May 2021

Study information

• Verified date: August 2017
• Source: Linkoeping University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Anxiety Disorders
• Disease
• Phobic Disorders
• Social Anxiety Disorder

Intervention

Behavioral:
• Internet-delivered cognitive behavior therapy
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.

Locations

Country	Name	City	State
Sweden	Umeå university	Umeå

Sponsors (5)

Lead Sponsor	Collaborator
Linkoeping University	Karolinska Institutet, Stockholm University, Umeå University, Uppsala University

Country where clinical trial is conducted

Sweden, 

References & Publications (4)

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

Outcome

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

External Links

•   Official website for the study