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

NCT ID: NCT02592564

Last Updated: 2017-09-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2021-05-31

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.

Conditions

Anxiety Disorders; Social Anxiety Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Psychological treatment

Psychological treatment during 9 weeks.

Group Type: EXPERIMENTAL

Internet-delivered cognitive behavior therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Internet-delivered CBT

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umeå University

OTHER

Sponsor Role: collaborator

Uppsala University

OTHER

Sponsor Role: collaborator

Stockholm University

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Linkoeping University

OTHER_GOV

Sponsor Role: lead

Responsible Party

Kristoffer NT Månsson

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kristoffer NT Månsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Stockholm University, Karolinska Institutet

Locations

Umeå university

Umeå, , Sweden

Countries

Sweden

References

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.

Reference Type: BACKGROUND

PMID: 24064198 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25781229 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25999120 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 11982446 (View on PubMed)

Other Identifiers

UMESTUDIEN-II

Identifier Type: -

Identifier Source: org_study_id