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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
52

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Intervention study
Cognitive Behavioural Therapy for social anxiety
Behavioral: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
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
Behavioral: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alzahra University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 20, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 13, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings