Social Anxiety DisorderNCT03946735
Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
A study testing Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination in people with Social Anxiety Disorder, run by Alzahra University.
Trial summary
This randomized, controlled trial study was designed to examine the efficacy of Cognitive Behavioural Therapy (CBT) on social anxiety, perfectionism, and rumination among individuals diagnosed with social anxiety in Tehran, Iran. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Social Anxiety Disorder
- What is being tested?
- Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2019to 20 Dec 2020
- 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
- Participants formally diagnosed with SAD by psychologists who determined the individual meet criteria outlined by the Diagnostic and Statistics Manual for Mental Disorders (DSM-5)
Who cannot join
- If participants report a history of psychiatric disorders within the past 12 months such as schizophrenia, dementia, depression, alcohol and other drug addiction.
- Participants could not partake if they were pregnant
- Participants enroll in another psychological treatment program.
About this study
This randomized, controlled trial study was designed to examine the efficacy of Cognitive Behavioural Therapy (CBT) on social anxiety, perfectionism, and rumination among individuals diagnosed with social anxiety in Tehran, Iran.
Read the detailed description
A total of 52 individuals with Social Anxiety Disorder (SAD) (68% female, mean age = 35.67) were allocated to a CBT group or to a control group. The intervention group was given one session of therapy per week over a duration of 8 weeks, while the control group did not receive any intervention and was placed on a waiting list. Self-reported social anxiety, perfectionism, and rumination were measured before the CBT intervention, after the intervention, and two months after the intervention for both groups.
- Conditions
- Social Anxiety Disorder
- Being tested
- Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
- Keywords
- Social Anxiety, Perfectionism, Rumination, Cognitive Behavioural Therapy
- Medical subject headings
- Phobia, Social, Rumination Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and RuminationBehavioural
Week one involved introducing CBT and assessing the negative effects of perfectionism, rumination, and social anxiety. Week two allowed participants to specify stressful social activities, stressful social situations, and enjoyable activities. Week three to week six allowed participants to identify automatic thoughts and thinking errors (for example, all or nothing thinking, self-criticism, dysfunctional schemas for self-evaluation, and unrealistic standards). Assignments were provided to participants with the content of exposure to anxiety evoking situations in the treatment sessions and at home. Achievable behavioural goals were set for participants in the treatment sessions and at home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention study | Experimental | Cognitive Behavioural Therapy for social anxiety Receives: Behavioral: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination |
| Social anxiety | Experimental | Not described Receives: Behavioral: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change: Social anxiety
Liebowitz Social Anxiety Scale for measuring social anxiety. this scale comprises of fear or anxiety and avoidance and sub-scales are combine (summed) to compute total score. Total score ranging from 0 to 144, and An individual who gets a total score over 60 in this measure is considered to have social anxiety
Measured: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)
Secondary outcomes (1)
Change: Rumination and Reflection
Rumination and Reflection Questionnair for measuring rumination and reflection: This scale comprises rumination and reflection. Each sub-scale comprises 12 items, and total scores ranged from 12 to 60. An individual who gets higher score is considered to have high rumination/ reflection.
Measured: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2019
- Study start1 Dec 2019 (estimated)
- Primary completion1 Jan 2020 (estimated)
- Study completion20 Dec 2020 (estimated)
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
- Participant
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alzahra University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abbas Abdollahi, Alzahra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03946735
- Sponsor's protocol ID
- Alzahra123456789
- Status last verified
- May 2019
- First submitted
- 7 May 2019
- Last updated
- 13 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
- ClinicalTrials.gov ID
- NCT03946735
- Acronym / sponsor ID
- Alzahra123456789
- Conditions
- Social Anxiety Disorder
- Keywords
- Social Anxiety, Perfectionism, Rumination, Cognitive Behavioural Therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (estimated)
- Lead sponsor
- Alzahra UniversityUniversity, hospital or other
- Study start
- 1 Dec 2019 (estimated)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 20 Dec 2020 (estimated)
- First posted
- 13 May 2019 (actual)
- 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 randomized, controlled trial study was designed to examine the efficacy of Cognitive Behavioural Therapy (CBT) on social anxiety, perfectionism, and rumination among individuals diagnosed with social anxiety in Tehran, Iran.
Detailed description
A total of 52 individuals with Social Anxiety Disorder (SAD) (68% female, mean age = 35.67) were allocated to a CBT group or to a control group. The intervention group was given one session of therapy per week over a duration of 8 weeks, while the control group did not receive any intervention and was placed on a waiting list. Self-reported social anxiety, perfectionism, and rumination were measured before the CBT intervention, after the intervention, and two months after the intervention for both groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention study | Experimental | Behavioral: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and RuminationCognitive Behavioural Therapy for social anxiety |
| Social anxiety | Experimental | Behavioral: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Participants formally diagnosed with SAD by psychologists who determined the individual meet criteria outlined by the Diagnostic and Statistics Manual for Mental Disorders (DSM-5)
Key exclusion criteria (3 listed)
- If participants report a history of psychiatric disorders within the past 12 months such as schizophrenia, dementia, depression, alcohol and other drug addiction.
- Participants could not partake if they were pregnant
- Participants enroll in another psychological treatment program.
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 |
|---|---|---|
| Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and RuminationWeek one involved introducing CBT and assessing the negative effects of perfectionism, rumination, and social anxiety. Week two allowed participants to specify stressful social activities, stressful social situations, and enjoyable activities. Week three to week six allowed participants to identify automatic thoughts and thinking errors (for example, all or nothing thinking, self-criticism, dysfunctional schemas for self-evaluation, and unrealistic standards). Assignments were provided to participants with the content of exposure to anxiety evoking situations in the treatment sessions and at home. Achievable behavioural goals were set for participants in the treatment sessions and at home. | Behavioural | Intervention study, Social anxiety |
Primary outcome
Change: Social anxiety
Time frame: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)
Liebowitz Social Anxiety Scale for measuring social anxiety. this scale comprises of fear or anxiety and avoidance and sub-scales are combine (summed) to compute total score. Total score ranging from 0 to 144, and An individual who gets a total score over 60 in this measure is considered to have social anxiety
1 secondary outcome
Change: Rumination and Reflection
Time frame: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months))
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination in people with Social Anxiety Disorder, run by Alzahra University.
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 1 inclusion and 3 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 13 May 2019. 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?
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?
Change: Social anxiety (time frame: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)). 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 13 May 2019.