Interpretation Modification Program for Social Phobia

Social Anxiety Disorder Clinical Trial

— SP Interp  

Official title:

Interpretation Modification Program for Social Phobia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00684541
• Other study ID #: 1-Amir
• Secondary ID: 5R34MH073004-03
• Status: Completed
• Phase: N/A
• First received: May 22, 2008
• Last updated: April 2, 2014
• Start date: September 2007
• Est. completion date: August 2011

Study information

• Verified date: April 2014
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobic Disorders
• Social Anxiety Disorder
• Social Phobia

Intervention

Behavioral:
• Interpretation Modification Program
The IMP protocol includes twelve 30-min sessions delivered over a 6-week period. 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. 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.
• Interpretation Control 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.

Locations

Country	Name	City	State
United States	San Diego State University	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
San Diego State University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebowitz Social Anxiety Scale (LSAS)	Our primary outcome measure was the clinician-administered LSAS (Liebowitz, 1987), a 24-item scale that provides separate scores for fear and avoidance of social interaction and performance situations. LSAS scores range from 0 to 144. The LSAS has strong psychometric properties (Heimberg et al., 1999) and is arguably the gold-standard outcome measure in treatment research in SAD (e.g., Clark et al., 2006; Heimberg et al., 1998). Higher scores indicate more severe symptoms.	Pre, Post (6 weeks), Followup (3 months after post-assessment)	No
Secondary	Social Phobia and Agoraphobia Inventory	Our secondary outcome assessment of social anxiety symptoms was the Social Phobia and Anxiety Inventory (SPAI; Turner, Beidel, Dancu, & Stanley, 1989), a 45-item self-rated measure that assesses the cognitive, behavioral, and somatic dimensions of SAD. SPAI scores range from 45 to 315, with higher scores indicating more severe symptoms. Previous research suggests that the SPAI has sound psychometric properties (e.g., Turner et al., 1989). Internal consistencies for these measures in the current sample were satisfactory.	Pre, Post (6 weeks), Followup (3 months after post-assessment)	No