Interpretation Modification Program for Social Phobia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- San Diego State University
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Liebowitz Social Anxiety Scale (LSAS)
Study Overview
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:
- benign interpretations is associated with improvement in social anxiety after treatment (e.g., Franklin, Huppert, Langner, Leiberg, & Foa, 2005)
- negative interpretations are implicated in the pathogenesis of SP (e.g., Rapee & Heimberg, 1997)
- SPs have more negative interpretations of social events than non-anxious controls and individuals with other anxiety disorders (e.g., Amir et al, 1998)
- 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:
- Individuals with GSP completing the Interpretation Modification Program (IMP) will show a reduction in their negative interpretation
- Participants in the IMP will show a decrease in their social anxiety symptoms
- 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Interpretation Modification Program
The IMP procedure was identical to the word-sentence association paradigm (WSAP; Beard & Amir, 2009) except participants received feedback about their responses. Participants received positive feedback when they endorsed benign interpretations or rejected threat interpretations of the ambiguous sentences on 100% of trials and negative feedback when they endorsed threat interpretations or rejected benign interpretations on 100% of trials. This feedback manipulation was intended to reinforce a benign interpretation bias and extinguish the threat interpretation bias. Participants completed two blocks of 110 training trials in each session. Participants who completed Set A during the WSAP assessment saw Set B during the IMP and vice versa. Each IMP session lasted approximately 20 min.
Intervention: Interpretation Modification Program (Behavioral)
Interpretation Control Condition
The ICC was identical to the IMP, except that participants received positive feedback when they endorsed threat interpretations on half (50%) of the trials and negative feedback when they endorsed threat interpretations for the remaining half (50%) of trials. This frequency was the same for benign interpretations. Thus, the control group was reinforced equally for making threat and benign interpretations. The ICC was not intended to change interpretation significantly in either direction.
Intervention: Interpretation Control Condition (Behavioral)
Outcomes
Primary Outcomes
Liebowitz Social Anxiety Scale (LSAS)
Time Frame: Pre, Post (6 weeks), Followup (3 months after post-assessment)
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.
Secondary Outcomes
- Social Phobia and Agoraphobia Inventory(Pre, Post (6 weeks), Followup (3 months after post-assessment))
Investigators
Nader Amir
Professor
San Diego State University