Social Anxiety DisorderSCE-CBTNCT02646865
Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety (SCE-CBT)
A study testing Self-Compassion Enhanced Cognitive-Behavioral Therapy and Cognitive-Behavioral Therapy in people with Social Anxiety Disorder, run by Babes-Bolyai University at 1 site in Romania.
Trial summary
This study evaluates the addition of a self-compassion training in the treatment of social anxiety disorder. Half of the participants will receive a self-compassion enhanced group cognitive-behavioral therapy, while the other half will receive standard group cognitive-behavioral therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Self-Compassion Enhanced Cognitive-Behavioral Therapy and Cognitive-Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteRomania
- Study dates
- Jan 2016to Jan 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- subjects diagnosed with Social Anxiety Disorders using the DSM-5 criteria
- subjects that have SAD as the primary diagnosis according to DSM-5 criteria
- exceed the cutoff scores on SPIN, SIAS, and LSAS-SR
Who cannot join
- subjects that score over 29 points at BDI-II
- display suicidal ideation (i.e., exceed a score of 2 on the suicide item of BDI-II)
- undergo other forms of treatment for SAD
- have a diagnosis of psychosis, bipolar disorder or personality disorders according to DSM-5 criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial on the Efficacy of Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety
This study evaluates the addition of a self-compassion training in the treatment of social anxiety disorder. Half of the participants will receive a self-compassion enhanced group cognitive-behavioral therapy, while the other half will receive standard group cognitive-behavioral therapy.
Read the detailed description
There is growing evidence showing that shame is associated with social anxiety. Also, empirical data shows that individuals with social anxiety have higher levels of shame compared with healthy individuals and that shame might play an important role in the maintenance of social anxiety symptoms. Although cognitive-behavioral therapy for social anxiety seems to reduce the level of shame-proneness, the magnitude of this reduction is a small one.
The purpose of this study is to test whether adding a self-compassion component (which seems to be effective in reducing shame feelings) to a cognitive-behavioral protocol would increase the efficacy of the treatment in reducing both shame-proneness and social anxiety symptoms compared with a standard cognitive-behavioral intervention.
- Conditions
- Social Anxiety Disorder
- Being tested
- Self-Compassion Enhanced Cognitive-Behavioral Therapy, Cognitive-Behavioral Therapy
- Keywords
- social phobia, compassion, shame
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Compassion Enhanced Cognitive-Behavioral TherapyBehavioural
12 group sessions of CBT for social anxiety based on Heimberg \& Becker's (2002) protocol with additional self-compassion exercises integrated into the treatment
Cognitive-Behavioral TherapyBehavioural
12 group sessions of CBT for social anxiety based on Heimberg \& Becker's (2002) protocol
| Study group | Role | What they receive |
|---|---|---|
| Self-Compassion Enhanced Cognitive-Behavioral Therapy | Experimental | Group Cognitive-Behavioral Therapy for social anxiety enhanced with exercises targeting self-compassion Receives: Behavioral: Self-Compassion Enhanced Cognitive-Behavioral Therapy |
| Cognitive-Behavioral Therapy | Active comparator | Standard Group Cognitive-Behavioral Therapy for social anxiety Receives: Behavioral: Cognitive-Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987)
Self-reported measure of social anxiety symptoms
Measured: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment) ; (3) 6 months after the end of treatment
Changes in social anxiety symptoms using SPIN (Social Phobia Inventory; Connor et al., 2000)
Self-reported measure of social anxiety symptoms
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)
Self-reported measure of social anxiety symptoms
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in shame-proneness using TOSCA-3 (Test of Self-Conscious Affect-3; Tangney, Dearing, Wagner, & Gramzow, 2000)
Self-reported measure of predisposition to experience shame
Measured: (1) baseline; (2) after 3, 6, 9 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of the treatment
Changes in social anxiety disorder clinical status
DSM-5 semi-structured interview for social anxiety disorder
Measured: at the end of the therapy
Secondary outcomes (11)
Changes in self-compassion using SCS (Self-Compassion Scale; Neff, 2003)
Self-reported measure of self-compassion
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2)at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in self-compassion using SCSs (Self-Compassion Scale Short Form; Raes et al., 2011)
Self-reported measure of self-compassion
Measured: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in depressive symptoms using BDI-II (Beck Depression Inventory-II; Beck, 1996)
Self-reported measure of depressive symptoms
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in positive and negative affect using PANAS (Positive and Negative Affect Schedule; Watson & Clark, 1999)
Self-reported measure of positive and negative affect
Measured: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in positive and negative emotions using PDA (Profile of Affective Distress; Opriș & Macavei, 2005)
Self-reported measure of positive and negative emotions
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in irrational and rational thinking using ABS-II (Attitudes and Beliefs Scale- 2; DiGiuseppe, Leaf, Exner, & Robin, 1988)
Self-reported measure of rational and irrational beliefs
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in emotion regulation using ERQ (Emotion Regulation Questionnaire; Gross & John, 2003)
Self-reported measure of the use of suppression and reappraisal
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in emotion regulation using DERS (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004)
Self-reported measure on emotion regulation strategies
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in rational and irrational beliefs using GABS (General Attitudes and Beliefs Scale; Bernard, 1998)
Self-reported measure of rational and irrational beliefs
Measured: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in social phobia related thoughts using BFNE (Brief Fear of Negative Evaluation Scale; Leary, 1983)
Self-reported measure of social phobia relevant negative thoughts
Measured: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in shame with PFQ-2 (Personal Feelings Questionnaire-2; Harder & Zalma, 1990)
Self-reported measure of shame
Measured: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2016 (estimated)
- Study startJan 2016
- Primary completionJul 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Babes-Bolyai University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Diana-Mirela Candea, Babes-Bolyai University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02646865
- Sponsor's protocol ID
- UBB-CLINPSY-2016-1
- Acronym
- SCE-CBT
- Status last verified
- Jul 2018
- First submitted
- 30 Dec 2015
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gilbert, P, Miles, JNV.Sensitivity to social put-down: Its relationship to perceptions of social rank, shame, social anxiety, depression, anger and self-other blame. Personality and Individual Differences, 29: 757-774, 2000.
Gilbert, P.The relationship of shame, social anxiety and depression: The role of the evaluation of social rank. Clin Psychol Psychother, 7: 174-189, 2000.
Fergus TA, Valentiner DP, McGrath PB, Jencius S. Shame- and guilt-proneness: relationships with anxiety disorder symptoms in a clinical sample. J Anxiety Disord. 2010 Dec;24(8):811-5. doi: 10.1016/j.janxdis.2010.06.002. Epub 2010 Jun 11.
PubMed 20591613Hedman E, Strom P, Stunkel A, Mortberg E. Shame and guilt in social anxiety disorder: effects of cognitive behavior therapy and association with social anxiety and depressive symptoms. PLoS One. 2013 Apr 19;8(4):e61713. doi: 10.1371/journal.pone.0061713. Print 2013.
PubMed 23620782Gilbert, P, Procter, S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. Clinical Psychology and Psychotherapy, 13(6): 353-379, 2006.
Heimberg, RG, & Becker, RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press, 2002.
Lutwak, N, Ferrari, JR.. Shame-related social anxiety: Replicating a link with various social interaction measures. Anxiety, stress, and coping, 10(4): 335-34, 1997.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial on the Efficacy of Self-Compassion Enhanced CBT vs. Standard CBT for Social Anxiety
- ClinicalTrials.gov ID
- NCT02646865
- Acronym / sponsor ID
- SCE-CBT / UBB-CLINPSY-2016-1
- Conditions
- Social Anxiety Disorder
- Keywords
- social phobia, compassion, shame
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Babes-Bolyai UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 6 Jan 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.
This study evaluates the addition of a self-compassion training in the treatment of social anxiety disorder. Half of the participants will receive a self-compassion enhanced group cognitive-behavioral therapy, while the other half will receive standard group cognitive-behavioral therapy.
Detailed description
There is growing evidence showing that shame is associated with social anxiety. Also, empirical data shows that individuals with social anxiety have higher levels of shame compared with healthy individuals and that shame might play an important role in the maintenance of social anxiety symptoms. Although cognitive-behavioral therapy for social anxiety seems to reduce the level of shame-proneness, the magnitude of this reduction is a small one.
The purpose of this study is to test whether adding a self-compassion component (which seems to be effective in reducing shame feelings) to a cognitive-behavioral protocol would increase the efficacy of the treatment in reducing both shame-proneness and social anxiety symptoms compared with a standard cognitive-behavioral intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-Compassion Enhanced Cognitive-Behavioral Therapy | Experimental | Behavioral: Self-Compassion Enhanced Cognitive-Behavioral TherapyGroup Cognitive-Behavioral Therapy for social anxiety enhanced with exercises targeting self-compassion |
| Cognitive-Behavioral Therapy | Active comparator | Behavioral: Cognitive-Behavioral TherapyStandard Group Cognitive-Behavioral Therapy for social anxiety |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects diagnosed with Social Anxiety Disorders using the DSM-5 criteria
- subjects that have SAD as the primary diagnosis according to DSM-5 criteria
- exceed the cutoff scores on SPIN, SIAS, and LSAS-SR
Key exclusion criteria (4 listed)
- subjects that score over 29 points at BDI-II
- display suicidal ideation (i.e., exceed a score of 2 on the suicide item of BDI-II)
- undergo other forms of treatment for SAD
- have a diagnosis of psychosis, bipolar disorder or personality disorders according to DSM-5 criteria
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 |
|---|---|---|
| Self-Compassion Enhanced Cognitive-Behavioral Therapy12 group sessions of CBT for social anxiety based on Heimberg \& Becker's (2002) protocol with additional self-compassion exercises integrated into the treatment | Behavioural | Self-Compassion Enhanced Cognitive-Behavioral Therapy |
| Cognitive-Behavioral Therapy12 group sessions of CBT for social anxiety based on Heimberg \& Becker's (2002) protocol | Behavioural | Cognitive-Behavioral Therapy |
Primary outcome
Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987)
Time frame: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment) ; (3) 6 months after the end of treatment
Self-reported measure of social anxiety symptoms
Changes in social anxiety symptoms using SPIN (Social Phobia Inventory; Connor et al., 2000)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Self-reported measure of social anxiety symptoms
Changes in social anxiety symptoms using SIAS (Social Interaction Anxiety Scale; Mattick & Clarke, 1998)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Self-reported measure of social anxiety symptoms
Changes in shame-proneness using TOSCA-3 (Test of Self-Conscious Affect-3; Tangney, Dearing, Wagner, & Gramzow, 2000)
Time frame: (1) baseline; (2) after 3, 6, 9 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of the treatment
Self-reported measure of predisposition to experience shame
Changes in social anxiety disorder clinical status
Time frame: at the end of the therapy
DSM-5 semi-structured interview for social anxiety disorder
11 secondary outcomes
Changes in self-compassion using SCS (Self-Compassion Scale; Neff, 2003)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2)at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in self-compassion using SCSs (Self-Compassion Scale Short Form; Raes et al., 2011)
Time frame: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in depressive symptoms using BDI-II (Beck Depression Inventory-II; Beck, 1996)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in positive and negative affect using PANAS (Positive and Negative Affect Schedule; Watson & Clark, 1999)
Time frame: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in positive and negative emotions using PDA (Profile of Affective Distress; Opriș & Macavei, 2005)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in irrational and rational thinking using ABS-II (Attitudes and Beliefs Scale- 2; DiGiuseppe, Leaf, Exner, & Robin, 1988)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in emotion regulation using ERQ (Emotion Regulation Questionnaire; Gross & John, 2003)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in emotion regulation using DERS (Difficulties in Emotion Regulation Scale; Gratz & Roemer, 2004)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in rational and irrational beliefs using GABS (General Attitudes and Beliefs Scale; Bernard, 1998)
Time frame: (1) baseline; (2) after 6 weeks from the start of the treatment; (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in social phobia related thoughts using BFNE (Brief Fear of Negative Evaluation Scale; Leary, 1983)
Time frame: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
Changes in shame with PFQ-2 (Personal Feelings Questionnaire-2; Harder & Zalma, 1990)
Time frame: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment); (3) 6 months after the end of treatment
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 18 Jul 2018.
- BackgroundGilbert, P, Miles, JNV.Sensitivity to social put-down: Its relationship to perceptions of social rank, shame, social anxiety, depression, anger and self-other blame. Personality and Individual Differences, 29: 757-774, 2000.
- BackgroundGilbert, P.The relationship of shame, social anxiety and depression: The role of the evaluation of social rank. Clin Psychol Psychother, 7: 174-189, 2000.
- Background: PubMed 20591613Fergus TA, Valentiner DP, McGrath PB, Jencius S. Shame- and guilt-proneness: relationships with anxiety disorder symptoms in a clinical sample. J Anxiety Disord. 2010 Dec;24(8):811-5. doi: 10.1016/j.janxdis.2010.06.002. Epub 2010 Jun 11.
- Background: PubMed 23620782Hedman E, Strom P, Stunkel A, Mortberg E. Shame and guilt in social anxiety disorder: effects of cognitive behavior therapy and association with social anxiety and depressive symptoms. PLoS One. 2013 Apr 19;8(4):e61713. doi: 10.1371/journal.pone.0061713. Print 2013.
- BackgroundGilbert, P, Procter, S. Compassionate mind training for people with high shame and self-criticism: Overview and pilot study of a group therapy approach. Clinical Psychology and Psychotherapy, 13(6): 353-379, 2006.
- BackgroundHeimberg, RG, & Becker, RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press, 2002.
- BackgroundLutwak, N, Ferrari, JR.. Shame-related social anxiety: Replicating a link with various social interaction measures. Anxiety, stress, and coping, 10(4): 335-34, 1997.
- Individual participant dataSharing planned: No
Related trials for Social Anxiety Disorder
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Recruiting
Comprehensive Assessment of Rehabilitation Experience Using the SAFE Scale
Caregiver Anxiety, Acquired Brain Injury
Not yet recruiting
Online Study on the Impact of a Self-Help Tool for Social Anxiety
Social Anxiety
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Compassion Enhanced Cognitive-Behavioral Therapy and Cognitive-Behavioral Therapy in people with Social Anxiety Disorder, run by Babes-Bolyai University at 1 site in Romania.
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 4 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 18 Jul 2018. 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 Romania. 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?
Changes in social anxiety symptoms using (Liebowitz Social Anxiety Scale; Leibowitz, 1987) (time frame: (1) baseline; (2) weekly for 11 weeks starting with the second week of treatment (2) at the of end of treatment (12 weeks after the start of the treatment) ; (3) 6 months after the end of treatment). The study lists 5 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 NCT02646865, which also lists 7 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 18 Jul 2018.