Social Anxiety DisorderNCT02490189
Mindfulness-based Intervention Versus CBT for Social Anxiety Disorder
A study testing Mindfulness-based Intervention and Cognitive Behavior Group Therapy in people with Social Anxiety Disorder, run by Hopital Montfort at 2 sites in Canada.
Trial summary
To conduct a prospective, randomized trial to compare the efficacy of a group mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive behavior group therapy (CBGT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Mindfulness-based Intervention and Cognitive Behavior Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 2 sitesCanada
- Study dates
- 25 Jul 2015to 21 Feb 2018
- 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
- DSM-5 diagnosis of social anxiety disorder (SAD) of at least moderate severity
- Montgomery Asberg Depression Rating Scale score ≤ 25
- Comorbid depressive disorders, panic disorder, agoraphobia, generalized anxiety disorder, specific phobias, eating disorders are allowed as long as the SAD is primary and predominates the clinical picture.
Who cannot join
- Coexisting Axis I disorders excluding those listed in the inclusion criteria
- Coexisting medical conditions that can alter the clinical presentation of SAD (e.g. Parkinson's disease)
- Lifetime history of bipolar disorder or psychotic symptoms
- Substance-related disorders in the last 12 months
- Acutely suicidal or history of suicide attempt in the past five years
- History of non-suicidal self-injurious behavior in the last 12 months
Show all 9Show fewer
- Currently receiving psychotherapy
- Currently engaged in a regular meditation or yoga practice
- Unable to attend weekly group sessions
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hopital Montfort
Ottawa, Ontario, K1K 0T1
Montfort Hospital
Ottawa, Ontario, K1K 0T1
About this study
Official title: Comparative Trial of a Mindfulness-based Intervention Versus Cognitive Behavior Therapy for Social Anxiety Disorder
To conduct a prospective, randomized trial to compare the efficacy of a group mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive behavior group therapy (CBGT).
Read the detailed description
The main aim of this comparative trial is to determine if the MBI-SAD will be noninferior to CBGT in improving core symptoms of social anxiety disorder, depressive symptoms, self, esteem, disability and quality of life. A secondary aim is to examine whether treatment gains are maintained over a 6-month period. Exploratory aims of the study are to: 1) determine if the MBI-SAD enhances self-compassion and mindfulness relative to CBGT; 2) determine if changes in self-compassion and mindfulness mediate the clinical response to the MBI-SAD; and 3) explore moderators of treatment response.
- Conditions
- Social Anxiety Disorder
- Being tested
- Mindfulness-based Intervention, Cognitive Behavior Group Therapy
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness-based InterventionBehavioural
Twelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure.
Cognitive Behavior Group TherapyBehavioural
Also called CBGT
Twelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-Based Intervention | Experimental | Participants in the mindfulness-based intervention arm will receive 12 weekly sessions of 2 to 2.5 hours duration. The intervention will be delivered in a group format. Participants will be assigned weekly homework. Receives: Behavioral: Mindfulness-based Intervention |
| Cognitive Behavior Group Therapy | Active comparator | Participants in the cognitive behavior group therapy arm will receive 12 weekly sessions of 2 to 2.5 hours in duration. Participants will be assigned weekly homework. Receives: Behavioral: Cognitive Behavior Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Liebowitz Social Anxiety Scale
A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations.
Measured: Change from baseline to week 12 and 6-month follow-up
Secondary outcomes (6)
Social Phobia Inventory
A 17-item self-report scale that assesses symptom domains of social anxiety.
Measured: Change from baseline to week 12 and 6-month follow-up
Clinical Global Impression Improvement Ratings
A 7-point clinician-rated scale that assesses level of clinical improvement.
Measured: Change from baseline to week 12 and 6-month follow-up
Beck Depression Inventory
A 21-item self-report measure of severity of depressive symptoms.
Measured: Change from baseline to week 12 and 6-month-follow-up
Social Adjustment Scale-Self Report Revised
A 49-item self-report scale that assesses functional impairment in multiple roles.
Measured: Change from baseline to week 12 and 6-month follow-up
Rosenberg Self-Esteem Scale
A 10-item self-report measure of self-esteem.
Measured: Change from baseline to week 12 and 6-month follow-up
Satisfaction with Life Questionnaire
A 5-item self-report scale that assesses overall satisfaction with life.
Measured: Change from baseline to week 12 and 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study start25 Jul 2015
- Primary completion15 Dec 2017
- Study completion21 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety DisorderStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Montfort
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation, University of Ottawa
- Responsible party
- Principal investigator, Diana Koszycki, Hopital Montfort
- Investigators
- Diana Koszycki, PhD, Principal investigator, Hopital Montfort
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490189
- Sponsor's protocol ID
- DK-27-02-15
- Status last verified
- Feb 2018
- First submitted
- 30 Jun 2015
- Last updated
- 22 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Trial of a Mindfulness-based Intervention Versus Cognitive Behavior Therapy for Social Anxiety Disorder
- ClinicalTrials.gov ID
- NCT02490189
- Acronym / sponsor ID
- DK-27-02-15
- Conditions
- Social Anxiety Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Hopital MontfortUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation, University of Ottawa
- Study start
- 25 Jul 2015 (actual)
- Primary completion
- 15 Dec 2017 (actual)
- Study completion
- 21 Feb 2018 (actual)
- First posted
- 3 Jul 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.
To conduct a prospective, randomized trial to compare the efficacy of a group mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive behavior group therapy (CBGT).
Detailed description
The main aim of this comparative trial is to determine if the MBI-SAD will be noninferior to CBGT in improving core symptoms of social anxiety disorder, depressive symptoms, self, esteem, disability and quality of life. A secondary aim is to examine whether treatment gains are maintained over a 6-month period. Exploratory aims of the study are to: 1) determine if the MBI-SAD enhances self-compassion and mindfulness relative to CBGT; 2) determine if changes in self-compassion and mindfulness mediate the clinical response to the MBI-SAD; and 3) explore moderators of treatment response.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-Based Intervention | Experimental | Behavioral: Mindfulness-based InterventionParticipants in the mindfulness-based intervention arm will receive 12 weekly sessions of 2 to 2.5 hours duration. The intervention will be delivered in a group format. Participants will be assigned weekly homework. |
| Cognitive Behavior Group Therapy | Active comparator | Behavioral: Cognitive Behavior Group TherapyParticipants in the cognitive behavior group therapy arm will receive 12 weekly sessions of 2 to 2.5 hours in duration. Participants will be assigned weekly homework. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-5 diagnosis of social anxiety disorder (SAD) of at least moderate severity
- Montgomery Asberg Depression Rating Scale score ≤ 25
- Comorbid depressive disorders, panic disorder, agoraphobia, generalized anxiety disorder, specific phobias, eating disorders are allowed as long as the SAD is primary and predominates the clinical picture.
Key exclusion criteria (9 listed)
- Coexisting Axis I disorders excluding those listed in the inclusion criteria
- Coexisting medical conditions that can alter the clinical presentation of SAD (e.g. Parkinson's disease)
- Lifetime history of bipolar disorder or psychotic symptoms
- Substance-related disorders in the last 12 months
- Acutely suicidal or history of suicide attempt in the past five years
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 |
|---|---|---|
| Mindfulness-based InterventionTwelve week group intervention that includes training in mindfulness meditation, self-compassion and mindful exposure. | Behavioural | Mindfulness-Based Intervention |
| Cognitive Behavior Group TherapyAlso: CBGTTwelve week group intervention that focuses on the interaction between thoughts, feelings, and behaviors. | Behavioural | Cognitive Behavior Group Therapy |
Primary outcome
Liebowitz Social Anxiety Scale
Time frame: Change from baseline to week 12 and 6-month follow-up
A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations.
6 secondary outcomes
Social Phobia Inventory
Time frame: Change from baseline to week 12 and 6-month follow-up
Clinical Global Impression Improvement Ratings
Time frame: Change from baseline to week 12 and 6-month follow-up
Beck Depression Inventory
Time frame: Change from baseline to week 12 and 6-month-follow-up
Social Adjustment Scale-Self Report Revised
Time frame: Change from baseline to week 12 and 6-month follow-up
Rosenberg Self-Esteem Scale
Time frame: Change from baseline to week 12 and 6-month follow-up
Satisfaction with Life Questionnaire
Time frame: Change from baseline to week 12 and 6-month follow-up
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 22 Feb 2018.
- 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.
Diana Koszycki, PhD principal investigator
Hopital Montfort
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness-based Intervention and Cognitive Behavior Group Therapy in people with Social Anxiety Disorder, run by Hopital Montfort at 2 sites in Canada.
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 9 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 22 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
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?
Liebowitz Social Anxiety Scale (time frame: Change from baseline to week 12 and 6-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Feb 2018.