NCT00948974

Brief Summary

The purpose of this study is to compare the efficacy of two variants of cognitive behavioral therapy (CBT) (cognitive therapy (CT) and acceptance and commitment therapy (ACT)), for the treatment of generalized social anxiety disorder.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2010

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

October 5, 2018

Completed
Last Updated

October 5, 2018

Status Verified

December 1, 2017

Enrollment Period

5 years

First QC Date

July 29, 2009

Results QC Date

May 8, 2017

Last Update Submit

December 7, 2017

Conditions

Keywords

social anxietytreatmentCognitive Behavioral TherapyAcceptance and Commitment TherapyCognitive Therapy

Outcome Measures

Primary Outcomes (1)

  • Social Phobia and Anxiety Inventory (SPAI) - Social Phobia Subscale

    The SPAI social phobia assess symptoms of social anxiety in the presence of (a) strangers, (b) authority figures, (c) members of the opposite sex, and (d) people in general. The subscale ranges from 32 to 192, where higher scores reflect more severe symptoms of social anxiety.

    baseline (pre-treatment; immediately prior to beginning treatment); post-treatment (12 weeks)

Secondary Outcomes (2)

  • Outcomes Questionnaire

    baseline (pre-treatment; just before beginning treatment); post-treatment (12 weeks)

  • Behavioral Assessment Test

    baseline (pre-treatment; just prior to beginning treatment); post-treatment (12 weeks)

Study Arms (2)

cognitive therapy

ACTIVE COMPARATOR

cognitive therapy and exposure

Behavioral: Cognitive Therapy

acceptance and committment therapy

ACTIVE COMPARATOR

acceptance and commitment therapy and exposure

Behavioral: Acceptance and Commitment Therapy

Interventions

Cognitive therapy (CT) highlights the identification and reappraisal of distorted or dysfunctional cognitions in the treatment of psychopathology. For example, socially anxious patients are taught to identify the thoughts and underlying beliefs that trigger strong emotional reactions (e.g., "if I attempt to initiate a conversation I'll humiliate myself"), and then replace these with more accurate, functional thoughts. There is a large body of research supporting the efficacy of CT for mood and anxiety disorders, and for social anxiety disorder in particular (Beck, 2005).

Also known as: CT
cognitive therapy

ACT does not attempt to modify cognitions directly, but rather seeks to foster a mindful acceptance of whatever thoughts or feelings arise, while still pursuing specific behavioral goals. For example, the individual would be taught simply to notice the thoughts as if from a distance without attempting to modify them, and initiate a conversation. Like other newer mindfulness and acceptance-based models of CBT, ACT also expands the traditional focus on symptom reduction to include an emphasis on broader life goals. The scientific literature on ACT has expanded rapidly over the past ten years. Recent reviews conclude that it appears to be at least as effective as CT, and may work at least in part via distinct treatment mechanisms (Powers, Zum Vörde Sive Vörding, \& Emmelkamp, 2009).

Also known as: ACT
acceptance and committment therapy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria)
  • aged 18-65
  • working fluency in English
  • residence in the greater Philadelphia area.

You may not qualify if:

  • Pervasive developmental disability
  • acute suicide potential
  • inability to travel to the treatment site
  • schizophrenia or other psychotic disorder
  • current substance dependence
  • Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Drexel University

Philadelphia, Pennsylvania, 19102, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral TherapyAcceptance and Commitment Therapy

Condition Hierarchy (Ancestors)

Phobic DisordersAnxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Results Point of Contact

Title
Evan Forman
Organization
Drexel University

Study Officials

  • James D. Herbert, PhD

    Drexel University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

July 29, 2009

First Posted

July 30, 2009

Study Start

January 1, 2010

Primary Completion

January 1, 2015

Study Completion

December 1, 2015

Last Updated

October 5, 2018

Results First Posted

October 5, 2018

Record last verified: 2017-12

Locations