NCT03946735

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 7, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 13, 2019

Completed
7 months until next milestone

Study Start

First participant enrolled

December 1, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2020

Completed
Last Updated

May 13, 2019

Status Verified

May 1, 2019

Enrollment Period

1 month

First QC Date

May 7, 2019

Last Update Submit

May 8, 2019

Conditions

Social Anxiety Disorder

Keywords

Social AnxietyPerfectionismRuminationCognitive Behavioural Therapy

Outcome Measures

Primary Outcomes (1)

  • 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

    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

    a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months))

Other Outcomes (1)

  • Change:Perfectionism

    a measure assessing change between three time points (pre-test, post-test (after two months), and follow-up test (after four months)

Study Arms (2)

Intervention study

EXPERIMENTAL

Cognitive Behavioural Therapy for social anxiety

Behavioral: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination

Social anxiety

EXPERIMENTAL
Behavioral: Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and Rumination

Interventions

Cognitive Behavioural Therapy as an Effective Treatment for Social Anxiety, Perfectionism, and RuminationBEHAVIORAL

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.

Intervention studySocial anxiety

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Phobia, SocialRumination Syndrome

Interventions

Cognitive Behavioral TherapyRumination, Digestive

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental DisordersGastrointestinal DiseasesDigestive System DiseasesFeeding and Eating Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesDigestionDigestive System Physiological PhenomenaDigestive System and Oral Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 13, 2019

Study Start

December 1, 2019

Primary Completion

January 1, 2020

Study Completion

December 20, 2020

Last Updated

May 13, 2019

Record last verified: 2019-05