Emotional DisordersNCT00586001
A Unified Treatment for Anxiety Disorders
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Emotional Disorders and Anxiety Disorders, run by Boston University Charles River Campus.
Trial summary
The purpose of this study is to develop a new psychological therapy for a variety of different types of emotional disorders. The study will compare symptoms and functioning of clients who receive the treatment with those who do not, and will include a number of assessments before, during, and after treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Emotional Disorders, Anxiety Disorders
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Nov 2010
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary Diagnosis of a DSM-IV Anxiety Disorder
Who cannot join
- Previous treatment with cognitive-behavioral therapy
- Receiving concurrent psychological treatments during study
- If on psychotropic medicine, requirement for stable dose for at least three months before treatment
About this study
Official title: Phase 3 of The Development of A Unified Treatment for Anxiety Disorders
The purpose of this study is to develop a new psychological therapy for a variety of different types of emotional disorders. The study will compare symptoms and functioning of clients who receive the treatment with those who do not, and will include a number of assessments before, during, and after treatment. We predict that patients receiving active treatment will show improved functioning relative to wait-list control.
Read the detailed description
Emotional disorders, specifically anxiety disorders and depression, are common, chronic, costly, and debilitating to quality of life (Barlow, 2002). Best estimates from various epidemiological studies place the one year prevalence of any anxiety disorder for individuals over 18 at 11.8%, and the one year prevalence of any mood disorder 5.1% (Narrow, Rae, Robins, \& Regier, 2002). Lifetime rates are higher. We understand the nature and causes of anxiety and unipolar mood disorders (major depressive disorder and dysthymia) somewhat better than 10 years ago, with evidence pointing to generalized biological and psychological vulnerabilities interacting with specific learning and, sometimes, stressful triggering life events as etiological factors (Barlow, 2002; Brown, Chorpita, \& Barlow, 1998). Pharmacological and psychological treatments have been proven effective, at least in the short term, but most studies have ignored the effects of treatment on broad-based patterns of comorbidity that accompany these disorders. Most comorbid disorders are usually additional emotional disorders (Brown, Campbell, Lehman, Grisham, \& Mancill, 2001). More importantly, treatment outcomes have been less than satisfactory or ineffective for up to 50% of patients, even for the principal disorder (Nathan \& Gorman, 2002). A common pharmacological treatment exists for many emotional disorders, which is selective serotonin re-uptake inhibitors (SSRIs) and closely related compounds. Effective psychological treatments, on the other hand, have been developed to be very specific to each DSM-IV diagnostic category. The purpose of this proposal is to create a unified psychological approach to the emotional disorders. To do, this we will take advantage of recent advances in our understanding of the nature of emotional disorders, as well as emerging knowledge of the process of regulation and change in emotional behavior, in order to distill and refine basic principles of successful psychological treatments. It is expected that this approach will simplify training and dissemination, possibly improve efficacy, and perhaps also shed further light on the nature of emotional disorders. Thus, the specific aims of this proposal are to:
- Develop and refine a unified psychological treatment for anxiety and non-bipolar mood disorders derived from distilling the major ingredients of current effective approaches in light of advancing knowledge of emotion regulation and modification.
- Revise and develop methods of evaluating adherence and outcome utilizing this new treatment protocol, focusing not only on symptom reduction but also quality of life and adaptive functioning.
- Treat a small number of patients with heterogeneous DSM-IV mood and anxiety diagnoses with this new protocol with the purpose of making appropriate modifications for a subsequent pilot study.
- Conduct a pilot study testing this unified treatment in comparison to a wait-list control condition in order to determine credibility and efficacy in terms of both symptomatic functioning and quality of life, and relating these outcomes to those from more disorder specific treatments.
- Conditions
- Emotional Disorders, Anxiety Disorders
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders
- Keywords
- Anxiety, Emotional Disorders, Unified, Depression
- Medical subject headings
- Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional DisordersBehavioural
Cognitive-behavioral treatment in development for emotional disorders
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Unified Protocol for Transdiagnostic Treatment of Emotional Disorders The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders. Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders |
| 2 | No intervention | Wait-list control: Participants were asked to wait 16 weeks before receiving treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule for DSM-IV
DSM-IV diagnoses of anxiety disorders. Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely disturbing/disabling) passing the clinical threshold for DSM-IV diagnostic criteria.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Secondary outcomes (18)
Structured Interview Guide for the Hamilton Anxiety Rating Scale
Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. Reported scores are the mean total scores.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Structured Interview Guide for the Hamilton Depression Rating Scale
Structured Interview Guide for the Hamilton Depression Rating Scale, items are scored on scale of 0 to 4, higher score meaning a higher severity. Total scores can range from 0 (no symptoms) to 53 (severe). Reported scores are a mean of the total scores.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Positive and Negative Affect Scale
Positive and Negative Affect Schedule-Negative Affectivity; Positive and Negative Affect Schedule-Positive Affectivity; Items are rated on a scale of 1 (very slightly or not at all) to 5 (extremely) relating to how a person feels average feels the indicated emotion. Total scores can range from 20 to 100. Higher scores are more severe. Reported scores are based on mean totals.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Beck Depression Inventory - II
Items are measured on a scale from 0 (little to no symptoms) to 3 (severe). Total scores can range from 0 to 63, higher ratings are more severe. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe. The reported scores are mean total scores.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Beck Anxiety Inventory
Items are scored on a 0 to 3 scale. Total scores range from 0 to 63. 0-9 is minimal, 10-16 is mild, 17-29 is moderate, and 30-63 is severe. Reported scores are a mean of total scores.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Work and Social Adjustment Scale
Items are scored on a 0 to 8 scale. The total score range is 0 to 40. Higher scores are more severe. Reported scores are means of total scores.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Panic Disorder Severity Scale - Self Report Version
Items are rated on a scale of 0 to 4. Scores can range from 0 to 28. Higher scores indicate higher severity of Panic Disorder symptoms
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Penn State Worry Questionnaire
The PSWQ is a 16-item questionnaire. Items are rated from 1 to 5, and a total score can range from 16 to 80. Higher scores indicate higher severity of worry symptoms.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Social Interaction Anxiety Scale
The SIAS is a twenty-item measure. Experiences are rated on a 5-point scale from 0 to 4. Experiences are rated on a global period of what is typical. A total score of 60 is possible with cutoffs of 34+ indicative of social phobia and 43+ indicative of social anxiety.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Quality of Life Inventory
The QOLI is a 32 item self-report, asking about the importance of 16 domains of life and a participant's satisfaction in each domain. Scores can range from -48 to 115. Higher scores indicate higher quality of life.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Yale-Brown Obsessive Compulsive Scale
The Y-BOCS is a 12-item scale used to see symptom severity of obsessions and compulsions. Items are scored from 0 to 4. The total score can range from 0 to 48. A higher score indicates higher symptom severity.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Emotion Regulation Questionnaire - 2
The ERQ-2 is a 16 item self-report. Items are scored from 1 to 7, and focus on emotional experience and emotional expression. Scores can range from 16 to 112, and higher scores indicate stronger cognitive reappraisal and expressive suppression abilities.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
BIS/BAS Scales (Carver & White, 1994)
The Behavioral Inhibition System/Behavioral Approach System Scales is a 20-item self-report where all items can be rated from 0 to 3. The total score can range from 0 to 60. Higher scores indicate higher levels of behavioral inhibition skills.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Affective Control Scale
The ACS is a 42 item scale where each item is rated from 1 to 7. Scores can range from 42 to 294. Higher scores indicate higher skill levels for controlling emotions
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Anxiety Sensitivity Index
The ASI is a 16 item self report where items can be scored from 0 to 4. Scores can range from 0 to 64. Higher scores indicate a higher sensitivity to anxiety and it's symptoms.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
The Thought-Action Fusion Scale (Shafran et al., 1996)
The TAF is a 19 item self report where each item can be scored from 0 to 4. Scores can range from 0 to 76. Higher scores indicate a higher frequency of maladaptive cognitive intrusions.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Intolerance of Uncertainty Scale (IUS)
The IUS is a 27-item self report where each item can be scored from 0 to 4. Scores range from 0 to 108. It rates response to uncertainty, ambiguous situations, and the future. Higher scores indicate higher anxiety and depressive symptoms.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
The TMMS is a 48 item self report where each item can be scored from 1 to 5. The three subscales are Attention, Clarity, and Repair. Scores for each of the three subscales can each range from 16 to 80. Higher scores indicate higher emotion regulation skills.
Measured: Measured at pre-treatment (baseline) and post-treatment (month 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2008 (estimated)
- Study startSep 2005
- Primary completionNov 2008
- Study completionNov 2010
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Emotional DisordersStudies 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
- Model description
- Treatment with the Unified Protocol (Arm 1) compared to a 16-week wait list control condition (Arm 2).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David H. Barlow, Boston University Charles River Campus
- Investigators
- David H Barlow, Ph.D, Principal investigator, Boston University Center for Anxiety and Related Disorders
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586001
- Sponsor's protocol ID
- 5R34MH070693-02
- Status last verified
- Nov 2018
- First submitted
- 21 Dec 2007
- Last updated
- 11 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brown TA, Chorpita BF, Barlow DH. Structural relationships among dimensions of the DSM-IV anxiety and mood disorders and dimensions of negative affect, positive affect, and autonomic arousal. J Abnorm Psychol. 1998 May;107(2):179-92. doi: 10.1037//0021-843x.107.2.179.
PubMed 9604548Brown TA, Campbell LA, Lehman CL, Grisham JR, Mancill RB. Current and lifetime comorbidity of the DSM-IV anxiety and mood disorders in a large clinical sample. J Abnorm Psychol. 2001 Nov;110(4):585-99. doi: 10.1037//0021-843x.110.4.585.
PubMed 11727948Barlow DH. Unraveling the mysteries of anxiety and its disorders from the perspective of emotion theory. Am Psychol. 2000 Nov;55(11):1247-63. doi: 10.1037//0003-066x.55.11.1247.
PubMed 11280938Barlow, D.H., Allen, L., & Choate, M.L. (2006). The Unified Protocol for Treatment of the Emotional Disorders. Unpublished manuscript, Boston University.
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 of The Development of A Unified Treatment for Anxiety Disorders
- ClinicalTrials.gov ID
- NCT00586001
- Acronym / sponsor ID
- 5R34MH070693-02
- Conditions
- Emotional Disorders, Anxiety Disorders
- Keywords
- Anxiety, Emotional Disorders, Unified, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- Sep 2005
- Primary completion
- Nov 2008 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 4 Jan 2008 (estimated)
- Results
- Posted 11 Dec 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to develop a new psychological therapy for a variety of different types of emotional disorders. The study will compare symptoms and functioning of clients who receive the treatment with those who do not, and will include a number of assessments before, during, and after treatment. We predict that patients receiving active treatment will show improved functioning relative to wait-list control.
Detailed description
Emotional disorders, specifically anxiety disorders and depression, are common, chronic, costly, and debilitating to quality of life (Barlow, 2002). Best estimates from various epidemiological studies place the one year prevalence of any anxiety disorder for individuals over 18 at 11.8%, and the one year prevalence of any mood disorder 5.1% (Narrow, Rae, Robins, \& Regier, 2002). Lifetime rates are higher. We understand the nature and causes of anxiety and unipolar mood disorders (major depressive disorder and dysthymia) somewhat better than 10 years ago, with evidence pointing to generalized biological and psychological vulnerabilities interacting with specific learning and, sometimes, stressful triggering life events as etiological factors (Barlow, 2002; Brown, Chorpita, \& Barlow, 1998). Pharmacological and psychological treatments have been proven effective, at least in the short term, but most studies have ignored the effects of treatment on broad-based patterns of comorbidity that accompany these disorders. Most comorbid disorders are usually additional emotional disorders (Brown, Campbell, Lehman, Grisham, \& Mancill, 2001). More importantly, treatment outcomes have been less than satisfactory or ineffective for up to 50% of patients, even for the principal disorder (Nathan \& Gorman, 2002). A common pharmacological treatment exists for many emotional disorders, which is selective serotonin re-uptake inhibitors (SSRIs) and closely related compounds. Effective psychological treatments, on the other hand, have been developed to be very specific to each DSM-IV diagnostic category. The purpose of this proposal is to create a unified psychological approach to the emotional disorders. To do, this we will take advantage of recent advances in our understanding of the nature of emotional disorders, as well as emerging knowledge of the process of regulation and change in emotional behavior, in order to distill and refine basic principles of successful psychological treatments. It is expected that this approach will simplify training and dissemination, possibly improve efficacy, and perhaps also shed further light on the nature of emotional disorders. Thus, the specific aims of this proposal are to:
- Develop and refine a unified psychological treatment for anxiety and non-bipolar mood disorders derived from distilling the major ingredients of current effective approaches in light of advancing knowledge of emotion regulation and modification.
- Revise and develop methods of evaluating adherence and outcome utilizing this new treatment protocol, focusing not only on symptom reduction but also quality of life and adaptive functioning.
- Treat a small number of patients with heterogeneous DSM-IV mood and anxiety diagnoses with this new protocol with the purpose of making appropriate modifications for a subsequent pilot study.
- Conduct a pilot study testing this unified treatment in comparison to a wait-list control condition in order to determine credibility and efficacy in terms of both symptomatic functioning and quality of life, and relating these outcomes to those from more disorder specific treatments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Treatment with the Unified Protocol (Arm 1) compared to a 16-week wait list control condition (Arm 2).
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional DisordersUnified Protocol for Transdiagnostic Treatment of Emotional Disorders The UP is a form of transdiagnostic cognitive-behavioral therapy (CBT) for individuals diagnosed with anxiety disorders, depression and related disorders. |
| 2 | No intervention | –Wait-list control: Participants were asked to wait 16 weeks before receiving treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary Diagnosis of a DSM-IV Anxiety Disorder
Key exclusion criteria (3 listed)
- Previous treatment with cognitive-behavioral therapy
- Receiving concurrent psychological treatments during study
- If on psychotropic medicine, requirement for stable dose for at least three months before treatment
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 |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional DisordersCognitive-behavioral treatment in development for emotional disorders | Behavioural | 1 |
Primary outcome
Anxiety Disorders Interview Schedule for DSM-IV
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
DSM-IV diagnoses of anxiety disorders. Principal and additional diagnoses are assigned a clinical severity rating (CSR) on a scale from 0 (no symptoms) to 8 (extremely severe symptoms), with a rating of 4 or above (definitely disturbing/disabling) passing the clinical threshold for DSM-IV diagnostic criteria.
18 secondary outcomes
Structured Interview Guide for the Hamilton Anxiety Rating Scale
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Structured Interview Guide for the Hamilton Depression Rating Scale
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Positive and Negative Affect Scale
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Beck Depression Inventory - II
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Beck Anxiety Inventory
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Work and Social Adjustment Scale
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Panic Disorder Severity Scale - Self Report Version
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Penn State Worry Questionnaire
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Social Interaction Anxiety Scale
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Quality of Life Inventory
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Yale-Brown Obsessive Compulsive Scale
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Emotion Regulation Questionnaire - 2
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
BIS/BAS Scales (Carver & White, 1994)
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Affective Control Scale
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Anxiety Sensitivity Index
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
The Thought-Action Fusion Scale (Shafran et al., 1996)
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Intolerance of Uncertainty Scale (IUS)
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
The Trait Meta-Mood Scale (TMMS; Salovey et al., 1995)
Time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 9604548Brown TA, Chorpita BF, Barlow DH. Structural relationships among dimensions of the DSM-IV anxiety and mood disorders and dimensions of negative affect, positive affect, and autonomic arousal. J Abnorm Psychol. 1998 May;107(2):179-92. doi: 10.1037//0021-843x.107.2.179.
- Background: PubMed 11727948Brown TA, Campbell LA, Lehman CL, Grisham JR, Mancill RB. Current and lifetime comorbidity of the DSM-IV anxiety and mood disorders in a large clinical sample. J Abnorm Psychol. 2001 Nov;110(4):585-99. doi: 10.1037//0021-843x.110.4.585.
- Background: PubMed 11280938Barlow DH. Unraveling the mysteries of anxiety and its disorders from the perspective of emotion theory. Am Psychol. 2000 Nov;55(11):1247-63. doi: 10.1037//0003-066x.55.11.1247.
- BackgroundBarlow, D.H., Allen, L., & Choate, M.L. (2006). The Unified Protocol for Treatment of the Emotional Disorders. Unpublished manuscript, Boston University.
- Center for Anxiety and Related Disorders at Boston University webpageLink provided by the sponsor.
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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.
David H Barlow, Ph.D principal investigator
Boston University Center for Anxiety and Related Disorders
Questions about this trial
What is this clinical trial studying?
A study testing Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in people with Emotional Disorders and Anxiety Disorders, run by Boston University Charles River Campus.
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 3 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 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 11 Dec 2018). 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?
Anxiety Disorders Interview Schedule for DSM-IV (time frame: Measured at pre-treatment (baseline) and post-treatment (month 3)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00586001, which also lists 4 linked publications.
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 11 Dec 2018.