Clinical trial NCT00684541: Interpretation Modification Program for Social Phobia
Official title: Interpretation Modification Program for Social Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Social Phobia
Keywords: Social Anxiety
Information Processing
Interpretation
Lead sponsor: San Diego State University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2008-05-26
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: Liebowitz Social Anxiety Scale (LSAS)
timeFrame: Pre, Post (6 weeks), Followup (3 months after post-assessment)
Secondary outcomes:
measure: Social Phobia and Agoraphobia Inventory
timeFrame: Pre, Post (6 weeks), Followup (3 months after post-assessment)
Other outcomes:
Locations:
city: San Diego
country: United States
facility: San Diego State University
state: California
Study officials:
affiliation: SDSU/UCSD
name: Nader Amir, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: