Social Anxiety DisorderSP InterpNCT00684541
Interpretation Modification Program for Social Phobia
A study testing Interpretation Modification Program in people with Social Anxiety Disorder and Social Phobia, run by San Diego State University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder, Social Phobia
- What is being tested?
- Interpretation Modification Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2007to Aug 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Principle DSM-IV-TR (APA, 2000) Diagnosis of social phobia - Generalized Type (GSP)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
San Diego State University
San Diego, California, 92120
About this study
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.
Read the 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.
- Conditions
- Social Anxiety Disorder, Social Phobia
- Being tested
- Interpretation Modification Program, Interpretation Control Condition
- Keywords
- Social Anxiety, Information Processing, Interpretation
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interpretation Modification ProgramBehavioural
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 ConditionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Interpretation Control Condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre, Post (6 weeks), Followup (3 months after post-assessment)
Secondary outcomes (1)
Social Phobia and Agoraphobia Inventory
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.
Measured: Pre, Post (6 weeks), Followup (3 months after post-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2008 (estimated)
- Study startSep 2007
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Social Anxiety DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- San Diego State University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Nader Amir, San Diego State University
- Investigators
- Nader Amir, Ph.D., Principal investigator, SDSU/UCSD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00684541
- Sponsor's protocol ID
- 1-Amir
- Other IDs
- 5R34MH073004-03
- Acronym
- SP Interp
- Status last verified
- Apr 2014
- First submitted
- 22 May 2008
- Last updated
- 1 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interpretation Modification Program for Social Phobia
- ClinicalTrials.gov ID
- NCT00684541
- Acronym / sponsor ID
- SP Interp / 1-Amir
- Conditions
- Social Anxiety Disorder, Social Phobia
- Keywords
- Social Anxiety, Information Processing, Interpretation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- San Diego State UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Sep 2007
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 26 May 2008 (estimated)
- Results
- Posted 1 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpretation Modification Program | Experimental | Behavioral: Interpretation Modification ProgramThe 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. |
| Interpretation Control Condition | Placebo comparator | Behavioral: Interpretation Control ConditionThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Principle DSM-IV-TR (APA, 2000) Diagnosis of social phobia - Generalized Type (GSP)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Interpretation Modification ProgramThe 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. | Behavioural | Interpretation Modification Program |
| Interpretation Control ConditionParticipants 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. | Behavioural | Interpretation Control Condition |
Primary outcome
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.
1 secondary outcome
Social Phobia and Agoraphobia Inventory
Time frame: Pre, Post (6 weeks), Followup (3 months after post-assessment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nader Amir, Ph.D. principal investigator
SDSU/UCSD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpretation Modification Program in people with Social Anxiety Disorder and Social Phobia, run by San Diego State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale (LSAS) (time frame: Pre, Post (6 weeks), Followup (3 months after post-assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2014.