Anxiety DisordersNCT01243606
Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders
A study testing Single Diagnosis Treatment Protocol and Unified Protocol (UP) in people with Anxiety Disorders and Mood Disorders, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more prevalent than any other class of disorders in every country in the world where surveys have been taken. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Mood Disorders
- What is being tested?
- Single Diagnosis Treatment Protocol and Unified Protocol (UP)
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to May 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- For inclusion, subjects will be males and females 18 years or older, fluent in the English language who have a principal DSM-IV diagnosis of SAD, PD/A, GAD, or OCD. In addition, to be eligible for participation, individuals must be willing to refrain from initiating additional treatment during the course of therapy unless mutually agreed upon with the therapists and the principal investigator; and willing to be randomly assigned to treatment conditions.
Who cannot join
- Patients will be excluded if they meet any of the following criteria:
- Current DSM-IV diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or organic mental disorder.
- Clear and current suicidal risk.
- Current or recent (past 90 days) history of substance abuse or drug dependence, with the exception of nicotine, marijuana, and caffeine.
- Individuals will also be excluded if they previously received an adequate trial of CBT or if their emotional symptomatology is due to a medical/physical condition in which case alternative treatment would be clinically indicated.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Related Disorders at Boston University
Boston, Massachusetts, 02215
About this study
Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more prevalent than any other class of disorders in every country in the world where surveys have been taken. Deepening understanding of the nature of anxiety and related emotional disorders during the last decade has revealed that commonalities in etiology and latent structure among these disorders supersedes differences. At the same time, examination of extant single diagnosis psychological treatment protocols (SDPs) for these disorders underscores mechanistic similarities. These findings suggested the possibility of distilling a set of psychological procedures that would comprise an innovative Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), and this protocol has now been developed. If efficacious, the UP may represent a more efficient and possibly more effective strategy which would render treatment implications of comorbidity, not otherwise specified (NOS) and subdefinitional threshold anxiety disorder conditions moot.
The investigators now propose an evaluation of the efficacy of the UP in a group of patients with heterogeneous anxiety disorders by way of rigorous comparisons to existing evidence based SDPs benchmarked against a wait list control condition, using both statistical equivalence and superiority analyses. Additional aims include determining the durability of the UP relative to comparison conditions after treatment discontinuation, and ascertaining the differential impact of treatments on disorder specific symptoms vs. higher-order temperamental variables. Further analyses will indicate if changes in these higher order temperamental variables mediate long-term outcome as preliminary data suggests, and if this mechanism of action differs among treatments.
Read the detailed description
The purpose of this proposal is to evaluate efficacy of the recently developed Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). This protocol takes advantage of recent advances in our understanding of the nature of anxiety disorders, as well as emerging knowledge of the process of regulation and change in anxious behavior, in order to distill and refine basic principles of successful psychological treatments for anxiety disorders. It is expected that this approach will simplify training and dissemination, provide better coverage for comorbid conditions, cover "not otherwise specified" (NOS) and sub-definitional threshold presentations, possibly improve efficacy particularly in the long term, and perhaps also shed further light on the nature of anxiety disorders.
A heterogeneous sample of 250 patients meeting diagnostic criteria for at least one of four anxiety disorders: Social Phobia (SAD), Panic Disorder with or without Agoraphobia (PD/A), Generalized Anxiety Disorder (GAD), or Obsessive Compulsive Disorder (OCD) will be randomized to one of three treatment cells: (1) the Unified Protocol (UP); (2) a single diagnosis psychological treatment protocol (SDP); or (3) Wait List (WL). A minimum of 50 patients from each of the 4 principal diagnostic categories will be included in the randomization to ensure adequate representation of each anxiety disorder. The study will consist of two phases: (1) a 12 or 16 week acute treatment phase (or 16 week WL) and (2) a 12-month follow-up phase, during which active treatments will be discontinued and patients will be followed to assess the long-term effects of treatment (outcome measures are discussed below). Patients randomized to the WL condition will not enter the post-treatment period. Rather, they will be immediately assigned to their choice of either UP or SDP treatment at the end of the sixteen week waiting period.
All assessment and treatment procedures will be conducted at the Center for Anxiety and Related Disorders (CARD) at Boston University, which is one of the largest research clinics devoted to anxiety and related emotional disorders in the world. Total duration for participation in the study will not exceed 18 months total.
The major aims of this proposal are to:
Primary Aims
Aim 1: Evaluate the efficacy of the UP applied to a group of patients with heterogeneous anxiety disorders as compared to a group receiving existing evidence-based single diagnosis treatment protocols (SDPs) benchmarked against a wait list control condition (WL) to determine the treatment responsiveness of the sample on common measures of outcome.
Aim 2: Evaluate the efficacy of both the UP and SDPs relative to a benchmark WL condition.
Aim 3: Determine long-term efficacy of UP relative to SDPs over a 1-year period following treatment discontinuation.
Aim 4: Examine the relative effects of each active treatment approach (UP \& SDPs) on comorbid anxiety and depressive disorder severity.
Secondary Aims
Aim 5: Ascertain the relative effects of each active treatment on higher-order temperamental indices.
Aim 6: Determine if change in higher order temperamental variables mediates long term outcome.
- Conditions
- Anxiety Disorders, Mood Disorders
- Being tested
- Single Diagnosis Treatment Protocol, Unified Protocol (UP)
- Keywords
- Anxiety, Depression, Obsessive Compulsive Disorder, Panic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Transdiagnostic Treatment, CBT
- Medical subject headings
- Anxiety Disorders, Mood Disorders, Depression, Obsessive-Compulsive Disorder, Panic Disorder, Generalized Anxiety Disorder, Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single Diagnosis Treatment ProtocolBehavioural
SDPs include: Managing Social Anxiety: A CBT Approach; Mastery of Anxiety and Panic-IV; Mastery of Anxiety and Worry-II; and Obsessive-Compulsive Disorder: A CBT Approach
Unified Protocol (UP)Behavioural
The UP is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. Treatment and session length of the UP will be matched to the SDPs for each principal diagnosis (see description above).
| Study group | Role | What they receive |
|---|---|---|
| Single Diagnosis Treatment Protocols | Experimental | Four disorder-specific cognitive-behavioral treatments will be conducted in accordance with treatment manuals of demonstrated efficacy. SDPs will be matched to the principal anxiety disorder diagnosis. Receives: Behavioral: Single Diagnosis Treatment Protocol |
| Unified Protocol | Experimental | The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders will be individually administered in accordance with a treatment protocol. Receives: Behavioral: Unified Protocol (UP) |
| Waitlist Control | No intervention | Waitlist participants will not receive treatment during a 16-week waitlist period, but will receive the treatment of their choice immediately following the 16 week waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule (ADIS): change over time
The ADIS is a semi-structured diagnostic interview designed to establish reliable DSM anxiety, mood, somatoform and substance use disorders. For each current diagnosis, interviewers assigned a 0-8 clinical severity rating (CSR) that indicates their judgment of the degree of distress and impairment associated with the disorder (0=none to 8=very severely disturbing/disabling). The information derived from the interview using the ADIS allows clinicians to determine differential diagnoses and gain a clear understanding of the level and severity of each diagnosis.
Measured: Baseline, every 4 weeks during a 16 week treatment or waitlist period, 6-month follow-up, 12-month follow-up
Secondary outcomes (8)
Clinical Global Impression Severity (CGI-S) and Improvement Scales (CGI-I): change over time
These widely used clinician-rated instruments assess global severity and improvement from pre-treatment baseline on 7-point scales. The CGI-S and CGI-I will be used to define clinical response.
Measured: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline), 6-month follow-up, 12-month follow-up
Structured Interview Guide for the Hamilton Anxiety and Depression Rating Scale (SIGH-A and SIGH-D): change over time
The SIGH-A and SIGH-D were developed to create a structured format for administering the Hamilton Anxiety Rating Scale (HARS; Hamilton, 1959) and the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960). Both include specific instructions on administration and anchor points for assigning severity ratings.
Measured: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Yale-Brown Obsessive Compulsive Scale Interview-II (Y-BOCS-II): change over time
Measured: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Panic Disorder Severity Scale (PDSS): change over time
Measured: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Liebowitz Social Anxiety Scale (LSAS): change over time
Measured: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Generalized Anxiety Disorder Severity Scale (GADSS): change over time
Measured: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Overall Anxiety Sensitivity and Impairment Scale (OASIS)/ Overall Depression Sensitivity and Impairment Scale (ODSIS): change over time
Measured: Baseline, every 4 weeks during a 16 week treatment or waitlist period, Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline), 6-month follow-up, 12-month follow-up
Work and Social Adjustment Scale (WSAS):change over time
Measured: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline), 6-month follow-up, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anxiety 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
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David H. Barlow, Boston University Charles River Campus
- Investigators
- David H Barlow, Ph.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01243606
- Sponsor's protocol ID
- 1R01MH090053-01
- Status last verified
- Oct 2017
- First submitted
- 12 Nov 2010
- Last updated
- 9 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Cardona ND, Ametaj AA, Cassiello-Robbins C, Tirpak JW, Olesnycky O, Sauer-Zavala S, Farchione TJ, Barlow DH. Outcomes of People of Color in an Efficacy Trial of Cognitive-Behavioral Treatments for Anxiety, Depression, and Related Disorders: Preliminary Evidence. J Nerv Ment Dis. 2023 Sep 1;211(9):711-720. doi: 10.1097/NMD.0000000000001692. Epub 2023 Jul 10.
PubMed 37432031Wilner Tirpak J, Cassiello-Robbins C, Ametaj A, Olesnycky OS, Sauer-Zavala S, Farchione TJ, Barlow DH. Changes in positive affect in cognitive-behavioral treatment of anxiety disorders. Gen Hosp Psychiatry. 2019 Nov-Dec;61:111-115. doi: 10.1016/j.genhosppsych.2019.06.008. Epub 2019 Jun 17.
PubMed 31253437Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
PubMed 28768327
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Evaluation of a Unified Transdiagnostic Treatment for Anxiety Disorders
- ClinicalTrials.gov ID
- NCT01243606
- Acronym / sponsor ID
- 1R01MH090053-01
- Conditions
- Anxiety Disorders, Mood Disorders
- Keywords
- Anxiety, Depression, Obsessive Compulsive Disorder, Panic Disorder, Generalized Anxiety Disorder, Social Anxiety Disorder, Transdiagnostic Treatment, CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2010
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 18 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Anxiety disorders are common, chronic, costly, debilitating to quality of life, and are more prevalent than any other class of disorders in every country in the world where surveys have been taken. Deepening understanding of the nature of anxiety and related emotional disorders during the last decade has revealed that commonalities in etiology and latent structure among these disorders supersedes differences. At the same time, examination of extant single diagnosis psychological treatment protocols (SDPs) for these disorders underscores mechanistic similarities. These findings suggested the possibility of distilling a set of psychological procedures that would comprise an innovative Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP), and this protocol has now been developed. If efficacious, the UP may represent a more efficient and possibly more effective strategy which would render treatment implications of comorbidity, not otherwise specified (NOS) and subdefinitional threshold anxiety disorder conditions moot.
The investigators now propose an evaluation of the efficacy of the UP in a group of patients with heterogeneous anxiety disorders by way of rigorous comparisons to existing evidence based SDPs benchmarked against a wait list control condition, using both statistical equivalence and superiority analyses. Additional aims include determining the durability of the UP relative to comparison conditions after treatment discontinuation, and ascertaining the differential impact of treatments on disorder specific symptoms vs. higher-order temperamental variables. Further analyses will indicate if changes in these higher order temperamental variables mediate long-term outcome as preliminary data suggests, and if this mechanism of action differs among treatments.
Detailed description
The purpose of this proposal is to evaluate efficacy of the recently developed Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP). This protocol takes advantage of recent advances in our understanding of the nature of anxiety disorders, as well as emerging knowledge of the process of regulation and change in anxious behavior, in order to distill and refine basic principles of successful psychological treatments for anxiety disorders. It is expected that this approach will simplify training and dissemination, provide better coverage for comorbid conditions, cover "not otherwise specified" (NOS) and sub-definitional threshold presentations, possibly improve efficacy particularly in the long term, and perhaps also shed further light on the nature of anxiety disorders.
A heterogeneous sample of 250 patients meeting diagnostic criteria for at least one of four anxiety disorders: Social Phobia (SAD), Panic Disorder with or without Agoraphobia (PD/A), Generalized Anxiety Disorder (GAD), or Obsessive Compulsive Disorder (OCD) will be randomized to one of three treatment cells: (1) the Unified Protocol (UP); (2) a single diagnosis psychological treatment protocol (SDP); or (3) Wait List (WL). A minimum of 50 patients from each of the 4 principal diagnostic categories will be included in the randomization to ensure adequate representation of each anxiety disorder. The study will consist of two phases: (1) a 12 or 16 week acute treatment phase (or 16 week WL) and (2) a 12-month follow-up phase, during which active treatments will be discontinued and patients will be followed to assess the long-term effects of treatment (outcome measures are discussed below). Patients randomized to the WL condition will not enter the post-treatment period. Rather, they will be immediately assigned to their choice of either UP or SDP treatment at the end of the sixteen week waiting period.
All assessment and treatment procedures will be conducted at the Center for Anxiety and Related Disorders (CARD) at Boston University, which is one of the largest research clinics devoted to anxiety and related emotional disorders in the world. Total duration for participation in the study will not exceed 18 months total.
The major aims of this proposal are to:
Primary Aims
Aim 1: Evaluate the efficacy of the UP applied to a group of patients with heterogeneous anxiety disorders as compared to a group receiving existing evidence-based single diagnosis treatment protocols (SDPs) benchmarked against a wait list control condition (WL) to determine the treatment responsiveness of the sample on common measures of outcome.
Aim 2: Evaluate the efficacy of both the UP and SDPs relative to a benchmark WL condition.
Aim 3: Determine long-term efficacy of UP relative to SDPs over a 1-year period following treatment discontinuation.
Aim 4: Examine the relative effects of each active treatment approach (UP \& SDPs) on comorbid anxiety and depressive disorder severity.
Secondary Aims
Aim 5: Ascertain the relative effects of each active treatment on higher-order temperamental indices.
Aim 6: Determine if change in higher order temperamental variables mediates long term outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Single Diagnosis Treatment Protocols | Experimental | Behavioral: Single Diagnosis Treatment ProtocolFour disorder-specific cognitive-behavioral treatments will be conducted in accordance with treatment manuals of demonstrated efficacy. SDPs will be matched to the principal anxiety disorder diagnosis. |
| Unified Protocol | Experimental | Behavioral: Unified Protocol (UP)The Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders will be individually administered in accordance with a treatment protocol. |
| Waitlist Control | No intervention | –Waitlist participants will not receive treatment during a 16-week waitlist period, but will receive the treatment of their choice immediately following the 16 week waiting period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- For inclusion, subjects will be males and females 18 years or older, fluent in the English language who have a principal DSM-IV diagnosis of SAD, PD/A, GAD, or OCD. In addition, to be eligible for participation, individuals must be willing to refrain from initiating additional treatment during the course of therapy unless mutually agreed upon with the therapists and the principal investigator; and willing to be randomly assigned to treatment conditions.
Key exclusion criteria (5 listed)
- Patients will be excluded if they meet any of the following criteria:
- Individuals will also be excluded if they previously received an adequate trial of CBT or if their emotional symptomatology is due to a medical/physical condition in which case alternative treatment would be clinically indicated.
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 |
|---|---|---|
| Single Diagnosis Treatment ProtocolSDPs include: Managing Social Anxiety: A CBT Approach; Mastery of Anxiety and Panic-IV; Mastery of Anxiety and Worry-II; and Obsessive-Compulsive Disorder: A CBT Approach | Behavioural | Single Diagnosis Treatment Protocols |
| Unified Protocol (UP)The UP is designed to help patients learn how to confront and experience uncomfortable emotions and learn how to respond to their emotions in more adaptive ways. Individual treatment sessions will be conducted by experienced clinicians who will be trained in the administration of this protocol. A workbook will be provided to each patient as part of this manualized treatment. Treatment and session length of the UP will be matched to the SDPs for each principal diagnosis (see description above). | Behavioural | Unified Protocol |
Primary outcome
Anxiety Disorders Interview Schedule (ADIS): change over time
Time frame: Baseline, every 4 weeks during a 16 week treatment or waitlist period, 6-month follow-up, 12-month follow-up
The ADIS is a semi-structured diagnostic interview designed to establish reliable DSM anxiety, mood, somatoform and substance use disorders. For each current diagnosis, interviewers assigned a 0-8 clinical severity rating (CSR) that indicates their judgment of the degree of distress and impairment associated with the disorder (0=none to 8=very severely disturbing/disabling). The information derived from the interview using the ADIS allows clinicians to determine differential diagnoses and gain a clear understanding of the level and severity of each diagnosis.
8 secondary outcomes
Clinical Global Impression Severity (CGI-S) and Improvement Scales (CGI-I): change over time
Time frame: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline), 6-month follow-up, 12-month follow-up
Structured Interview Guide for the Hamilton Anxiety and Depression Rating Scale (SIGH-A and SIGH-D): change over time
Time frame: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Yale-Brown Obsessive Compulsive Scale Interview-II (Y-BOCS-II): change over time
Time frame: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Panic Disorder Severity Scale (PDSS): change over time
Time frame: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Liebowitz Social Anxiety Scale (LSAS): change over time
Time frame: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Generalized Anxiety Disorder Severity Scale (GADSS): change over time
Time frame: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline),6-month follow-up, 12-month follow-up
Overall Anxiety Sensitivity and Impairment Scale (OASIS)/ Overall Depression Sensitivity and Impairment Scale (ODSIS): change over time
Time frame: Baseline, every 4 weeks during a 16 week treatment or waitlist period, Post-Treatment (12-16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline), 6-month follow-up, 12-month follow-up
Work and Social Adjustment Scale (WSAS):change over time
Time frame: Baseline, Post-Treatment (approximately 16 weeks after Baseline) or Post-Wait List (16 weeks after Baseline), 6-month follow-up, 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2017.
- Derived from this study: PubMed 37432031Cardona ND, Ametaj AA, Cassiello-Robbins C, Tirpak JW, Olesnycky O, Sauer-Zavala S, Farchione TJ, Barlow DH. Outcomes of People of Color in an Efficacy Trial of Cognitive-Behavioral Treatments for Anxiety, Depression, and Related Disorders: Preliminary Evidence. J Nerv Ment Dis. 2023 Sep 1;211(9):711-720. doi: 10.1097/NMD.0000000000001692. Epub 2023 Jul 10.
- Derived from this study: PubMed 31253437Wilner Tirpak J, Cassiello-Robbins C, Ametaj A, Olesnycky OS, Sauer-Zavala S, Farchione TJ, Barlow DH. Changes in positive affect in cognitive-behavioral treatment of anxiety disorders. Gen Hosp Psychiatry. 2019 Nov-Dec;61:111-115. doi: 10.1016/j.genhosppsych.2019.06.008. Epub 2019 Jun 17.
- Derived from this study: PubMed 28768327Barlow DH, Farchione TJ, Bullis JR, Gallagher MW, Murray-Latin H, Sauer-Zavala S, Bentley KH, Thompson-Hollands J, Conklin LR, Boswell JF, Ametaj A, Carl JR, Boettcher HT, Cassiello-Robbins C. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders Compared With Diagnosis-Specific Protocols for Anxiety Disorders: A Randomized Clinical Trial. JAMA Psychiatry. 2017 Sep 1;74(9):875-884. doi: 10.1001/jamapsychiatry.2017.2164.
- Visit our website to learn more about the study.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single Diagnosis Treatment Protocol and Unified Protocol (UP) in people with Anxiety Disorders and Mood Disorders, run by Boston University Charles River Campus 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 9 Oct 2017. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (ADIS): change over time (time frame: Baseline, every 4 weeks during a 16 week treatment or waitlist period, 6-month follow-up, 12-month follow-up). 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 NCT01243606, which also lists 3 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 9 Oct 2017.