Interpretation Modification Program for Social Phobia

NCT00684541 | Completed Results DMC

• 2 other identifiers: 1-Amir5R34MH073004-03
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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.

Conditions

Social Anxiety Disorder; Social Phobia

Keywords

Social Anxiety; Information Processing; Interpretation

Outcome Measures

Primary Outcomes (1)

• 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)

Secondary Outcomes (1)

• Social Phobia and Agoraphobia Inventory

  Pre, Post (6 weeks), Followup (3 months after post-assessment)

Study Arms (2)

Interpretation Modification Program

EXPERIMENTAL

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.

Behavioral: Interpretation Modification Program

Interpretation Control Condition

PLACEBO COMPARATOR

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.

Behavioral: Interpretation Control Condition

Interventions

Interpretation Modification Program 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 Modification Program

Interpretation Control Condition 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.

Interpretation Control Condition

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• San Diego State University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

San Diego State University

San Diego, California, 92120, United States

Location

MeSH Terms

Conditions

Phobia, Social

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Professor Nader Amir
• Organization: SDSU

namir@mail.sdsu.edu

6192293744

Study Officials

• Nader Amir, Ph.D.

  SDSU/UCSD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 22, 2008
• First Posted: May 26, 2008
• Study Start: September 1, 2007
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: May 1, 2014
• Results First Posted: May 1, 2014

Record last verified: 2014-04

Locations

US (1)