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Interpretation Modification Program for Social Phobia (SP Interp)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00684541
First Posted: May 26, 2008
Last Update Posted: May 1, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Nader Amir, San Diego State University
  Purpose
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.

Condition Intervention
Social Anxiety Disorder Social Phobia Behavioral: Interpretation Modification Program Behavioral: Interpretation Control Condition

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Interpretation Modification Program for Social Phobia

Resource links provided by NLM:


Further study details as provided by Nader Amir, San Diego State University:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • Social Phobia and Agoraphobia Inventory [ Time Frame: Pre, Post (6 weeks), Followup (3 months after post-assessment) ]
    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.


Enrollment: 49
Study Start Date: September 2007
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.
Placebo Comparator: 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.
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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00684541


Locations
United States, California
San Diego State University
San Diego, California, United States, 92120
Sponsors and Collaborators
San Diego State University
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Nader Amir, Ph.D. SDSU/UCSD
  More Information

Responsible Party: Nader Amir, Professor, San Diego State University
ClinicalTrials.gov Identifier: NCT00684541     History of Changes
Other Study ID Numbers: 1-Amir
5R34MH073004-03 ( U.S. NIH Grant/Contract )
First Submitted: May 22, 2008
First Posted: May 26, 2008
Results First Submitted: December 13, 2013
Results First Posted: May 1, 2014
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Nader Amir, San Diego State University:
Social Anxiety
Information Processing
Interpretation

Additional relevant MeSH terms:
Anxiety Disorders
Phobic Disorders
Mental Disorders


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