Trial · NCT00074802
Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
NCT00074802, Phase 3, Completed, Temple University; results first posted 2017-06-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder. Trials, record NCT00074802. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00074802
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Adding Cognitive Behavioral Therapy to Drug Treatment for Social Anxiety Disorder
- NCT number
- NCT00074802
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 150 participants, actual
- Lead sponsor
- Temple University
- Conditions
- Social Anxiety Disorder
- Interventions
- Paroxetine, Cognitive behavioral therapy (CBT)
- First posted
- 2003-12-22
- Last updated
- 2017-06-14
- Results first posted
- 2017-06-14
- Limitations and caveats
- Limitations include the small size of the randomized sample and the lack of a placebo arm in the randomization phase of the study.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Liebowitz Social Anxiety Scale (LSAS) | Change measured from Week 12 to Week 28 | The LSAS is a 24-item clinician-administered measure, which provides 0-3 ratings for anxiety and avoidance of social and performance situations. Anxiety and avoidance ratings are summed across items, yielding a range of scores from 0-144, with higher scores representing greater severity of social anxiety symptoms. We examined amount of change from week 12 to week 28 as the primary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change. |
| Secondary | Clinical Global Impression Improvement Scale (CGI-I) | Responder and remitter status measured at Week 28 | The CGI-I is a 7-point clinician-administered scale measuring improvement in symptoms over time. Lower numbers represent greater improvement. We examined responder status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1 or 2) as well as remission status (i.e., percent of patients receiving an endpoint, Week 28, rating of 1) as secondary outcomes. |
| Secondary | Social Interaction Anxiety Scale (SIAS) | Change measured from Week 12 to Week 28 | The SIAS is a 20-item self-report measure of anxiety experienced while interacting in dyads or groups. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change. |
| Secondary | Social Phobia Scale (SPS) | Change measured from Week 12 to Week 28 | The SPS is a 20-item self-report measure of anxiety experienced when being observed by others. Items are rated on a 0-4 scale, yielding a range of scores from 0-80, with higher scores representing greater anxiety. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change. |
| Secondary | Brief Fear of Negative Evaluation Scale (BFNE) | Change measured from Week 12 to Week 28 | The BFNE is a 12-item self-report measure of concern about negative evaluation by others. Items are rated on a 1-5 scale, yielding scores ranging from 12-60, with higher scores indicating greater fear of negative evaluation. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change. |
| Secondary | Liebowitz Self-Report Disability Scale (LSRDS) | Change measured from Week 12 to Week 28 | The LSRDS is an 11-item self-report measure of the degree to which one's emotional problems limit one's ability to function in a variety of domains. Items are rated on a 0-3 scale of severity, and 10 of the 11 items (choosing either school or work as one area and omitting the other) are summed to produce a total score, ranging from 0-30. Higher scores represent greater disability. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change. |
| Secondary | Quality of Life Inventory (QOLI) | Change measured from Week 12 to Week 28 | The QOLI is a 16-item self-report measure of life satisfaction. Each item is rated for importance (0-2) and satisfaction (-3 to +3), and these ratings are multiplied, summed, and divided by the number of non-zero entries to yield an average item score, which can range from -6 to +6. We examined amount of change at from week 12 to week 28 as a secondary outcome. Change was calculated as Week 12 score minus Week 28 score, so a positive score equals greater positive change. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Liebowitz Social Anxiety Scale (LSAS) | Change measured from Week 12 to Week 28 | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | units on a scale | MEAN |
| SECONDARY | Clinical Global Impression Improvement Scale (CGI-I) | Responder and remitter status measured at Week 28 | Responders (CGI-I=1 or 2). Remitters (CGI-I=1). Analyses based on Week 28 observations if available. if not, Week 20 or Week 12 observations were substituted. Fisher's Exact Test used for analyses. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Social Interaction Anxiety Scale (SIAS) | Change measured from Week 12 to Week 28 | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | units on a scale | MEAN |
| SECONDARY | Social Phobia Scale (SPS) | Change measured from Week 12 to Week 28 | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | units on a scale | MEAN |
| SECONDARY | Brief Fear of Negative Evaluation Scale (BFNE) | Change measured from Week 12 to Week 28 | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | units on a scale | MEAN |
| SECONDARY | Liebowitz Self-Report Disability Scale (LSRDS) | Change measured from Week 12 to Week 28 | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | units on a scale | MEAN |
| SECONDARY | Quality of Life Inventory (QOLI) | Change measured from Week 12 to Week 28 | Data analysis was conducted via mixed-effects linear regression which allows use of data from patients with missing observations by using maximum likelihood estimation. The same holds true for all continuous outcome measures. However, mean change (and SDs) reported here is based on completed observations. | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Liebowitz Social Anxiety Scale (LSAS) | Paroxetine Continuation | 7.77 | Standard Deviation 22.49 | units on a scale | |
| Liebowitz Social Anxiety Scale (LSAS) | Paroxetine With CBT Augmentation | 7.84 | Standard Deviation 17.15 | units on a scale | |
| Clinical Global Impression Improvement Scale (CGI-I) | Paroxetine Continuation | Responder Status / Responder | 17 | Participants | |
| Clinical Global Impression Improvement Scale (CGI-I) | Paroxetine With CBT Augmentation | Responder Status / Responder | 28 | Participants | |
| Clinical Global Impression Improvement Scale (CGI-I) | Paroxetine Continuation | Responder Status / Non-Responder | 12 | Participants | |
| Clinical Global Impression Improvement Scale (CGI-I) | Paroxetine With CBT Augmentation | Responder Status / Non-Responder | 4 | Participants | |
| Clinical Global Impression Improvement Scale (CGI-I) | Paroxetine Continuation | Remitter Status / Responder | 3 | Participants | |
| Clinical Global Impression Improvement Scale (CGI-I) | Paroxetine With CBT Augmentation | Remitter Status / Responder | 11 | Participants | |
| Clinical Global Impression Improvement Scale (CGI-I) | Paroxetine Continuation | Remitter Status / Non-Responder | 26 | Participants | |
| Clinical Global Impression Improvement Scale (CGI-I) | Paroxetine With CBT Augmentation | Remitter Status / Non-Responder | 21 | Participants |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Paroxetine Continuation | 29 | |
| Overall Study | STARTED | Paroxetine With CBT Augmentation | 32 | |
| Overall Study | COMPLETED | Paroxetine Continuation | 20 | |
| Overall Study | COMPLETED | Paroxetine With CBT Augmentation | 25 | |
| Overall Study | NOT COMPLETED | Paroxetine Continuation | 9 | |
| Overall Study | NOT COMPLETED | Paroxetine With CBT Augmentation | 7 |
Source ClinicalTrials.gov
Adverse events60
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | General disorders | Paroxetine Continuation | 11 | 29 | 25 |
| other | Headache | General disorders | Paroxetine With CBT Augmentation | 11 | 32 | 23 |
| other | Palpitations | General disorders | Paroxetine Continuation | 10 | 29 | 29 |
| other | Palpitations | General disorders | Paroxetine With CBT Augmentation | 5 | 32 | 9 |
| other | Myalgia | General disorders | Paroxetine Continuation | 10 | 29 | 20 |
| other | Myalgia | General disorders | Paroxetine With CBT Augmentation | 2 | 32 | 6 |
| other | Nausea | General disorders | Paroxetine Continuation | 11 | 29 | 16 |
| other | Nausea | General disorders | Paroxetine With CBT Augmentation | 6 | 32 | 10 |
| other | Vomiting | General disorders | Paroxetine Continuation | 4 | 29 | 5 |
| other | Vomiting | General disorders | Paroxetine With CBT Augmentation | 4 | 32 | 5 |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Paroxetine Continuation | 0 | 29 |
| Total, all-cause mortality | Paroxetine With CBT Augmentation | 0 | 32 |
| Total, other adverse events | Paroxetine Continuation | 29 | 29 |
| Total, other adverse events | Paroxetine With CBT Augmentation | 29 | 32 |
| Total, serious adverse events | Paroxetine Continuation | 1 | 29 |
| Total, serious adverse events | Paroxetine With CBT Augmentation | 0 | 32 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants2
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|---|---|---|---|---|---|
| R01MH064481 | CBT Augmentation of Paroxetine for Social Anxiety | HEIMBERG, RICHARD G | TEMPLE UNIV OF THE COMMONWEALTH | NATIONAL INSTITUTE OF MENTAL HEALTH | 2003 to 2006 | NIH RePORTER |
| R01MH064726 | CBT Augmentation of Paroxetine for Social Anxiety | LIEBOWITZ, MICHAEL R. | NEW YORK STATE PSYCHIATRIC INSTITUTE DBA RESEARCH FOUNDATION FOR MENTAL HYGIENE, INC | NATIONAL INSTITUTE OF MENTAL HEALTH | 2003 to 2006 | NIH RePORTER |
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Paroxetine Continuation vs Paroxetine With CBT Augmentation: deaths from any cause | Trial comparisons |
| Paroxetine Continuation vs Paroxetine With CBT Augmentation: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00074802
GET https://conductscience.org/api/trials/v1/NCT00074802/events?page=2