Interpretation Modification Program for Social Phobia

NCT ID: NCT00684541

Last Updated: 2014-05-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2011-08-31

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.

Conditions

Social Anxiety Disorder; Social Phobia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Interpretation Modification Program

Intervention Type: BEHAVIORAL

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

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.

Group Type: PLACEBO_COMPARATOR

Interpretation Control Condition

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

San Diego State University

OTHER

Sponsor Role: lead

Responsible Party

Nader Amir

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Nader Amir, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

SDSU/UCSD

Locations

San Diego State University

San Diego, California, United States

Countries

United States

Other Identifiers

5R34MH073004-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1-Amir

Identifier Type: -

Identifier Source: org_study_id