Social AnxietyNCT02792127
Online Program for Social Anxiety
A study testing Online Program for Social Anxiety in people with Social Anxiety, run by University of British Columbia.
Trial summary
The purpose of this study is to investigate the efficacy of an online program in reducing symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative evaluations and improving quality of life in students with above-average social anxiety. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety
- What is being tested?
- Online Program for Social Anxiety
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Dec 2017
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Registered UBC student
- Achieve an above-average score on a validated screening tool for social anxiety
Who cannot join
- Not a registered UBC student
- Clinical diagnosis of a mental illness
About this study
Official title: Online Cognitive Behavioural Therapy Program for Social Anxiety
The purpose of this study is to investigate the efficacy of an online program in reducing symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative evaluations and improving quality of life in students with above-average social anxiety.
Read the detailed description
While there are many benefits to online programs in treating a variety of health issues (i.e., implementation in remote areas, cost-effectiveness, etc.), the primary challenge for online formats is to imitate real-life interactions while promoting a reduction in symptoms. This will be attempted in a six-month online program for social anxiety.
The present study will assess the efficacy of a six-month online program through measures of social anxiety, fear of negative evaluations, unhelpful thoughts, avoidance behaviours and quality of life. This information will be collected from students at baseline and upon completion of the online program.
- Conditions
- Social Anxiety
- Being tested
- Online Program for Social Anxiety
- Keywords
- Social Anxiety, Cognitive Behaviour Therapy, Online Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Program for Social AnxietyBehavioural
This program will be completed from participants' homes using their own computers. This online format is based on a Cognitive Behaviour Therapy framework (CBT) and involves seven modules that ask participants to engage in a variety of thinking exercises and activities.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | These participants will be given access to a six-month online program for social anxiety. Receives: Behavioral: Online Program for Social Anxiety |
| Wait List Control | No intervention | These participants will not be given an intervention until after they have completed the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Social Anxiety
A self-report measure that assesses symptoms of distress experienced when socializing with others.
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Social AnxietyStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Frances Chen, University of British Columbia
- Investigators
- Frances Chen, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02792127
- Sponsor's protocol ID
- H16-00319
- Status last verified
- Dec 2017
- First submitted
- 2 Jun 2016
- Last updated
- 29 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Helgadottir FD, Ross MG, Onslow M, Packman A, O'Brian, S. Online CBT II: A phase I trial of a standalone, online CBT Treatment Program for Social Anxiety in Stuttering. Behaviour Change 26(4): 254-270. 2009.
Helgadottir FD, Menzies RG, Onslow M, Packman A, O'Brian S. Online CBT I: Bridging the gap between Eliza and modern online CBT treatment packages. Behaviour Change 26(4): 245-253, 2009.
McCall HC, Richardson CG, Helgadottir FD, Chen FS. Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial. J Med Internet Res. 2018 Mar 21;20(3):e91. doi: 10.2196/jmir.8630.
PubMed 29563078
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Online Cognitive Behavioural Therapy Program for Social Anxiety
- ClinicalTrials.gov ID
- NCT02792127
- Acronym / sponsor ID
- H16-00319
- Conditions
- Social Anxiety
- Keywords
- Social Anxiety, Cognitive Behaviour Therapy, Online Program
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 7 Jun 2016 (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.
The purpose of this study is to investigate the efficacy of an online program in reducing symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative evaluations and improving quality of life in students with above-average social anxiety.
Detailed description
While there are many benefits to online programs in treating a variety of health issues (i.e., implementation in remote areas, cost-effectiveness, etc.), the primary challenge for online formats is to imitate real-life interactions while promoting a reduction in symptoms. This will be attempted in a six-month online program for social anxiety.
The present study will assess the efficacy of a six-month online program through measures of social anxiety, fear of negative evaluations, unhelpful thoughts, avoidance behaviours and quality of life. This information will be collected from students at baseline and upon completion of the online program.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Online Program for Social AnxietyThese participants will be given access to a six-month online program for social anxiety. |
| Wait List Control | No intervention | –These participants will not be given an intervention until after they have completed the study. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Registered UBC student
- Achieve an above-average score on a validated screening tool for social anxiety
Key exclusion criteria (2 listed)
- Not a registered UBC student
- Clinical diagnosis of a mental illness
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 |
|---|---|---|
| Online Program for Social AnxietyThis program will be completed from participants' homes using their own computers. This online format is based on a Cognitive Behaviour Therapy framework (CBT) and involves seven modules that ask participants to engage in a variety of thinking exercises and activities. | Behavioural | Experimental |
Primary outcome
Social Anxiety
Time frame: six months
A self-report measure that assesses symptoms of distress experienced when socializing with others.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2017.
- BackgroundHelgadottir FD, Ross MG, Onslow M, Packman A, O'Brian, S. Online CBT II: A phase I trial of a standalone, online CBT Treatment Program for Social Anxiety in Stuttering. Behaviour Change 26(4): 254-270. 2009.
- BackgroundHelgadottir FD, Menzies RG, Onslow M, Packman A, O'Brian S. Online CBT I: Bridging the gap between Eliza and modern online CBT treatment packages. Behaviour Change 26(4): 245-253, 2009.
- Derived from this study: PubMed 29563078McCall HC, Richardson CG, Helgadottir FD, Chen FS. Evaluating a Web-Based Social Anxiety Intervention Among University Students: Randomized Controlled Trial. J Med Internet Res. 2018 Mar 21;20(3):e91. doi: 10.2196/jmir.8630.
- Individual participant dataSharing planned: No
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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.
Frances Chen, PhD principal investigator
University of British Columbia
Questions about this trial
What is this clinical trial studying?
A study testing Online Program for Social Anxiety in people with Social Anxiety, run by University of British Columbia.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 29 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Social Anxiety (time frame: six months). 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 NCT02792127, which also lists 3 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 29 Dec 2017.