Interpretation Modification Program for Social Phobia (SP Interp)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by San Diego State University.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
San Diego State University
ClinicalTrials.gov Identifier:
NCT00684541
First received: May 22, 2008
Last updated: May 28, 2008
Last verified: April 2008
  Purpose

Generalized Social Phobia is characterized by severe social anxiety that leads to functional impairment (Schneider et al., 1992). Despite its high prevalence, many individuals do not receive treatment or are unresponsive to current therapies. Thus there is a clear need to continue to develop highly effective and efficient treatments for social phobia. This three year project aims to test a computerized treatment for social phobia in a double-blind, placebo-controlled study designed to modify interpretation biases that may maintain anxiety.


Condition Intervention
Social Anxiety Disorder
Social Phobia
Behavioral: Interpretation Modification Program
Behavioral: Placebo Condition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interpretation Modification Program for Social Phobia

Resource links provided by NLM:


Further study details as provided by San Diego State University:

Primary Outcome Measures:
  • Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: Pre, Post, Followup ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Social Phobia and Agoraphobia Inventory [ Time Frame: Pre, Post, Followup ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: September 2007
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1: IMP
Interpretation Modification Program
Behavioral: Interpretation Modification Program
The IMP protocol includes twelve 30-min sessions delivered over a 6-week period (i.e., bi-weekly sessions). Each session will comprise 220 trials. In each trial, participants will first see either a non-threat or a threat (e.g. "graceful" or "clumsy") word on the computer screen. They will then see an ambiguous sentence (e.g. "You dance at the party") and will be asked to indicate if the word and sentence were related by pressing a corresponding key. The computer will then provide feedback regarding their "accuracy." Participants will receive feedback contingent upon their responses. Thus, participants will receive positive feedback (i.e., "You are correct!") when they endorse a non-threat interpretation or reject a threat interpretation of an ambiguous sentence. Participants will receive negative feedback (i.e., "You are incorrect.") when they endorse a threat interpretation or reject a non-threat interpretation of an ambiguous sentence.
Placebo Comparator: 2: PC
Placebo Condition
Behavioral: Placebo Condition
Participants assigned to the PC completed an identical procedure to the IMP procedure except that feedback about participants' performance was not contingent on the type of interpretation (i.e., non-threat or threat) endorsed. Thus, participants in the PC received positive feedback 50% of the time when viewing a threat interpretation and 50% of the time when viewing a non-threat interpretation.

Detailed Description:

Social phobia is characterized by severe social anxiety leading to functional impairment (Schneider et al., 1992). Despite its high prevalence (13%, Kessler et al., 1994) over 30% of individuals with social anxiety who need treatment do not receive treatment (Olfson, et al., 2000) and 40% of individuals who present for treatment do not respond (39%, Heimberg, et al., 1998; 42%, Liebowitz et al., 2005). Thus, there is a clear need to develop highly effective and efficient treatments for GSP. Reducing negative interpretation of social events is an efficacious treatment for SP because:

  1. benign interpretations is associated with improvement in social anxiety after treatment (e.g., Franklin, Huppert, Langner, Leiberg, & Foa, 2005)
  2. negative interpretations are implicated in the pathogenesis of SP (e.g., Rapee & Heimberg, 1997)
  3. SPs have more negative interpretations of social events than non-anxious controls and individuals with other anxiety disorders (e.g., Amir et al, 1998)
  4. this bias ameliorates after successful treatment (e.g., Stopa & Clark, 2000).

Therefore, changing negative interpretations is an efficacious treatment for SP, and current cognitive-behavioral therapies use cognitive restructuring (CR) to target negative interpretations and replace them with more benign interpretations (Heimberg, et al., 1998). The goal of the current proposal is to test a new computerized treatment for SP that is designed to change negative interpretations. We chose a computerized intervention to increase efficiency and ease of delivery. We chose to test this intervention in GSP because interpretation bias is especially relevant to this clinical population. The long-term goal of this project is to improve service delivery using a widely available and economical intervention for GSP. More specifically, we will test three hypotheses in this proposal:

  1. Individuals with GSP completing the Interpretation Modification Program (IMP) will show a reduction in their negative interpretation
  2. Participants in the IMP will show a decrease in their social anxiety symptoms
  3. Change in social anxiety symptoms will be mediated by the change in interpretation scores, suggesting that interpretation change reduced social anxiety symptoms.

Pilot data (n=34) suggest that this intervention is efficacious. Thus, we aim to develop further and validate this highly efficient treatment for changing interpretations as a cost-effective treatment for patients with social phobia.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Principle DSM-IV-TR (APA, 2000) Diagnosis of social phobia - Generalized Type (GSP)

Exclusion Criteria:

  • No change in medication type or dosage twelve weeks prior to initiating treatment
  • No current psychotherapy
  • No evidence of suicidal intent
  • No evidence of substance abuse in the last 6 months
  • No evidence of current or past schizophrenia, bipolar disorder, or organic mental disorder
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00684541

Contacts
Contact: Nader Amir, Ph.D. 619-229-3740 namir@mail.sdsu.edu

Locations
United States, California
San Diego State University Recruiting
San Diego, California, United States, 92120
Contact: Nader Amir, Ph.D.    619-229-3740    namir@mail.sdsu.edu   
Sponsors and Collaborators
San Diego State University
Investigators
Principal Investigator: Nader Amir, Ph.D. SDSU/UCSD
  More Information

No publications provided

Responsible Party: Nader Amir, Ph.D., San Diego State University
ClinicalTrials.gov Identifier: NCT00684541     History of Changes
Other Study ID Numbers: 1-Amir
Study First Received: May 22, 2008
Last Updated: May 28, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by San Diego State University:
Social Anxiety
Information Processing
Interpretation

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014