- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03946735
Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
May 8, 2019 updated by: Abbas Abdollahi, Alzahra University
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.
Study Overview
Status
Unknown
Conditions
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 Type
Interventional
Enrollment (Anticipated)
52
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: Intervention study
Cognitive Behavioural Therapy for social anxiety
|
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.
|
|
EXPERIMENTAL: Social anxiety
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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))
|
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.
|
a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months))
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change:Perfectionism
Time Frame: a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)
|
Almost Perfect Scale-Revised for measuring perfectionism: This scale comprises 23 items, but only 12 items associated to discrepancy (as a measure of maladaptive perfectionism or clinical perfectionism) are utilized in this study.
Total scores ranged from 12 to 84 and higher score indicates higher level of perfectionism.
|
a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
December 1, 2019
Primary Completion (ANTICIPATED)
January 1, 2020
Study Completion (ANTICIPATED)
December 20, 2020
Study Registration Dates
First Submitted
May 7, 2019
First Submitted That Met QC Criteria
May 8, 2019
First Posted (ACTUAL)
May 13, 2019
Study Record Updates
Last Update Posted (ACTUAL)
May 13, 2019
Last Update Submitted That Met QC Criteria
May 8, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Alzahra123456789
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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