Anxiety DisordersUMEIINCT02592564
Brain Plasticity and Cellular Aging After Internet-delivered CBT for Social Anxiety Disorder
A study testing Internet-delivered cognitive behavior therapy in people with Anxiety Disorders and Social Anxiety Disorder, run by Linkoeping University at 1 site in Sweden.
Trial summary
This study evaluates underlying psychological and biological mediators in Internet-delivered cognitive behavior therapy for adults with social anxiety disorder. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anxiety Disorders, Social Anxiety Disorder
- What is being tested?
- Internet-delivered cognitive behavior therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2015to May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Social Anxiety Disorder as primary diagnosis (DSM-5)
- Otherwise somatically healthy
- Willingness to participate in a symptom provocation brain imaging trial
Who cannot join
- 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
Show all 16Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Brain´s Plasticity and Change in Cellular Aging After Internet-delivered Cognitive Behavior Therapy for Social Anxiety Disorder
This study evaluates underlying psychological and biological mediators in Internet-delivered cognitive behavior therapy for adults with social anxiety disorder.
Read the 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
- Being tested
- Internet-delivered cognitive behavior therapy
- Keywords
- Magnetic Resonance Imaging, Cognitive Behavior Therapy, Telomerase, Telomere Length, Mean Leukocyte
- Medical subject headings
- Anxiety Disorders, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-delivered cognitive behavior therapyBehavioural
Also called Internet-delivered CBT
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.
| Study group | Role | What they receive |
|---|---|---|
| Psychological treatment | Experimental | Psychological treatment during 9 weeks. Receives: Behavioral: Internet-delivered cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Clinician administrated telephone-interview to determine the participant´s severity of illness
Measured: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Social Phobia Screening Questionnaire (SPSQ)
Self reported social anxiety symptoms on distress (scoring 0-4) in 24 social situations.
Measured: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Beck Anxiety Inventory (BAI)
Self reported anxiety symptoms
Measured: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Social Interaction Anxiety Scale (SIAS)
Self reported social anxiety symptoms on distress (scoring 0-4) in 21 social situations.
Measured: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Social Phobia Scale (SPS)
Self reported social anxiety symptoms on distress (scoring 0-4) in 20 social situations.
Measured: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Montgomery Åsberg Depression Rating Scale, Self-report version (MADRS-S)
Self reported depressive symptoms (scoring 0-6).
Measured: Screening, Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
Subjective unit of discomfort on fear and distress (SUD)
Self reported scoring 0-100 on fear and distress separately
Measured: Before experimental tasks while undergoing MRI, at Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
Social Probability/Cost Questionnaire
40 items scoring 0 to 8. Foa et al., 1996, J Abnormal Psychology
Measured: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
Quality of Life (QOLI)
Measured: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Social Network Index (SNI)
Bickart et al., 2010, Nat Neurosci
Measured: Baseline 1 (week 0)
Brown Attention-Deficit Disorder Scales (Brown ADD)
Measured: Baseline 1 (week 0)
Difficulties in Emotion Regulation Scale (DERS)
Measured: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment), and at 6, 12, and 60 months
Treatment Credibility Scale (TCS)
Measured: Baseline 2 (week 9), week 13 during treatment
Revised NEO Personality Inventory (NEO-PI-R)
Measured: Baseline 1 (week 0)
Insomnia Severity Index (ISI)
Measured: Baseline 1 (week 0)
Karolinska Sleep Questionnaire (KSQ)
Measured: Baseline 1 (week 0)
State-Trait Anxiety Inventory (STAI-T)
Measured: Baseline 1 (week 0)
State-Trait Anxiety Inventory (STAI-S)
Measured: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
MINI International Neuropsychiatric Interview
Swedish version 7.0.0
Measured: Screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionApr 2017
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Linkoeping University
- Sponsor type
- Other government
- Collaborators
- Umeå University, Uppsala University, Stockholm University, Karolinska Institutet
- Responsible party
- Principal investigator, Kristoffer NT Månsson, Stockholm University
- Investigators
- Kristoffer NT Månsson, PhD, Principal investigator, Stockholm University, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592564
- Sponsor's protocol ID
- UMESTUDIEN-II
- Acronym
- UMEII
- Status last verified
- Aug 2017
- First submitted
- 23 Oct 2015
- Last updated
- 1 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24064198Mansson 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.
PubMed 25781229Lindqvist 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.
PubMed 25999120Furmark 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.
PubMed 11982446
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brain´s Plasticity and Change in Cellular Aging After Internet-delivered Cognitive Behavior Therapy for Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02592564
- Acronym / sponsor ID
- UMEII / UMESTUDIEN-II
- Conditions
- Anxiety Disorders, Social Anxiety Disorder
- Keywords
- Magnetic Resonance Imaging, Cognitive Behavior Therapy, Telomerase, Telomere Length, Mean Leukocyte
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Linkoeping UniversityOther government
- Collaborators
- Umeå University, Uppsala University, Stockholm University, Karolinska Institutet
- Study start
- Oct 2015
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2021 (estimated)
- First posted
- 30 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Psychological treatment | Experimental | Behavioral: Internet-delivered cognitive behavior therapyPsychological treatment during 9 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Social Anxiety Disorder as primary diagnosis (DSM-5)
- Otherwise somatically healthy
- Willingness to participate in a symptom provocation brain imaging trial
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet-delivered cognitive behavior therapyAlso: Internet-delivered CBTInternet-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. | Behavioural | Psychological treatment |
Primary outcome
Clinically Global Impression-Improvement scale (CGI-I; Change from baseline)
Time frame: At week 20 (post-treatment), and at 6, 12, and 60 months
Clinician administrated telephone-interview to determine the participant´s treatment response rates (very much worse to very much improved)
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
Self reported social anxiety symptoms on fear (scoring 0-3) and avoidance (scoring 0-3) in 24 social situations.
19 secondary outcomes
Clinically Global Impression-Severity scale (CGI-S)
Time frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Social Phobia Screening Questionnaire (SPSQ)
Time frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Beck Anxiety Inventory (BAI)
Time frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Social Interaction Anxiety Scale (SIAS)
Time frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Social Phobia Scale (SPS)
Time frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
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
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)
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
Quality of Life (QOLI)
Time frame: Screening, week 20 (post-treatment), and at 6, 12, and 60 months
Social Network Index (SNI)
Time frame: Baseline 1 (week 0)
Brown Attention-Deficit Disorder Scales (Brown ADD)
Time frame: Baseline 1 (week 0)
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
Treatment Credibility Scale (TCS)
Time frame: Baseline 2 (week 9), week 13 during treatment
Revised NEO Personality Inventory (NEO-PI-R)
Time frame: Baseline 1 (week 0)
Insomnia Severity Index (ISI)
Time frame: Baseline 1 (week 0)
Karolinska Sleep Questionnaire (KSQ)
Time frame: Baseline 1 (week 0)
State-Trait Anxiety Inventory (STAI-T)
Time frame: Baseline 1 (week 0)
State-Trait Anxiety Inventory (STAI-S)
Time frame: Baseline 1 (week 0), Baseline 2 (week 9), week 13 during treatment, week 20 (post-treatment)
MINI International Neuropsychiatric Interview
Time frame: Screening
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2017.
- Background: PubMed 24064198Mansson 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.
- Background: PubMed 25781229Mansson 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.
- Background: PubMed 25999120Lindqvist 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.
- Background: PubMed 11982446Furmark 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristoffer NT Månsson, PhD principal investigator
Stockholm University, Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Internet-delivered cognitive behavior therapy in people with Anxiety Disorders and Social Anxiety Disorder, run by Linkoeping University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinically Global Impression-Improvement scale (CGI-I; Change from baseline) (time frame: At week 20 (post-treatment), and at 6, 12, and 60 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02592564, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2017.