AnxietyNCT02944994
Effectiveness of a Unified Transdiagnostic Treatment in Routine Care
A study testing Unified protocol and Routine Care in people with Anxiety and Traumatic Stress Disorders, run by Boston University at 1 site in United States.
Trial summary
The purpose of this study is to examine effectiveness and implementation for the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in trauma exposed veterans. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Anxiety, Traumatic Stress Disorders, Depression
- What is being tested?
- Unified protocol and Routine Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 71 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 12 Feb 2019
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- VA Boston Health Care Patient:
- Definition: Currently enrolled as a patient at VA Boston Healthcare System
- Diagnosis of an emotional disorder Definition: Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of any emotional disorder (anxiety disorder, traumatic stress disorders, or unipolar depression)
- Cognitive Functioning:
- Definition: free of cognitive impairment demonstrated by ability to understand and provide consent
- Psychotherapy:
Show all 10Show fewer
- Definition: not currently in psychotherapy for an emotional disorder treated in the study
- Stakeholder Inclusion Criteria
- Provider Status:
- Definition: Providing or overseeing mental health treatment in VA Boston Healthcare System and VA Puget Sound Healthcare System
Who cannot join
- Veteran Participant Exclusionary Criteria
- Current diagnosis of substance dependence (but not abuse)
- Primary diagnosis of bipolar disorder
- Current diagnosis of psychosis
- High suicidal risk (plan with intent)
- Recent change in psychiatric medications (< 3 months prior to entering the study).
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Boston Healthcare System
Boston, Massachusetts, 02130
About this study
Official title: Effectiveness of a Unified Transdiagnostic Treatment in Routine Clinical Care
The purpose of this study is to examine effectiveness and implementation for the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in trauma exposed veterans.
Read the detailed description
Anxiety and mood diagnoses are chronic and devastating with respect to costs to the individual and the healthcare system, and are more prevalent than any other class of disorders. When these disorders present concurrently, the significant public health implications and societal costs are intensified. Despite high rates of comorbidity and underlying mechanistic similarities between treatment protocols, single disorder evidence- based psychotherapy protocols for these disorders have traditionally been recommended to treat emotional disorders sequentially. Moreover, when clinicians are presented with complex case presentations, they are often unprepared to treat them and move away from evidence-based approaches, potentially increasing the burden on the mental health system. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an innovative transdiagnostic protocol with promising evidence for successful treatment of emotional disorders, both for standalone and comorbid presentations, including the classification of not otherwise specified (NOS) disorders. To date, there have only been efficacy trials of the UP, which limit generalizability and do not address the larger public health impact and effectiveness in routine clinical care settings with both psychiatric and medical comorbidity. To address this critical limitation, the applicant proposes a pilot feasibility, acceptability, and tolerability study of the UP in patients with diverse psychiatric and medical comorbidity to manualized supportive therapy within a hospital. The deployment focused model (DFM) will inform design and statistical analyses. An additional aim includes determining the feasibility, acceptability, perceived fit and satisfaction of the UP in clinic settings through surveying and interviewing stakeholders in the system that are implementing the UP through the study. Consultation with stakeholders can minimize the time required to collect and assess fit within the larger system and, therefore, minimizes the time lag between science and practice in routine care settings. This study addresses an important public health concern by examining the effectiveness of the UP in a new population as a strategy for treatment of common and debilitating mental disorders in routine care settings. Furthermore, the proposed research aims will complement a comprehensive training plan to prepare the applicant to become an independent investigator with expertise in implementation science and effectiveness research. Results from the study will provide important information about whether or not this efficacious treatment can be effective, efficient, and ready for implementation in routine care settings in which psychiatric and medical comorbidity are common. This study will also serve as a model of deploying efficacious treatments into generalist clinics.
- Conditions
- Anxiety, Traumatic Stress Disorders, Depression
- Being tested
- Unified protocol, Routine Care
- Medical subject headings
- Anxiety Disorders, Stress Disorders, Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified protocolOther
This is a transdiagnostic cognitive behavioral therapy
Routine CareOther
This arm will reflect typical care received in routine mental health care
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol | Experimental | Unified Protocol-psychotherapy Receives: Other: Unified protocol |
| Routine Care | Experimental | Routine Care psychotherapy comparison Receives: Other: Routine Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Barriers and facilitators that impact implementation of the intervention measured by the Consolidated Framework for Implementation Research (CFIR)
These interviews will occur at one time point and will be analyzed with Qualitative Comparative Analyses guided by the Consolidated Framework for Implementation Research. Qualitative analyses are often descriptive in nature and a summary of common themes are reported to speak to factors impacting implementation of the intervention in this population. NVivo software will be used to aggregate the qualitative interviews from all participants and highlight the common themes across CFIR interviews
Measured: One time assessment, occurring on 1 day, approximately 4 months after treatment initiation
Change in clinician administered Anxiety Disorders Interview Scheduled will be used to generate clinical diagnoses for mental health disorders
Change will be examined from baseline through the end of treatment. For each participant it will be reported if there was a change in each participants clinician administered diagnostic assessment and the resulting clinician severity rating for each mental health diagnosis. This assessment will be used in conjunction with the CAPS-5 (outcome 3) to inform the presence or absence of clinical diagnoses at baseline and follow-up. Each has it's own metric, but can be used to show the presence or absence of a clinical level of the diagnosis
Measured: 7 months
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) will be used to asses the presence or absence of a clinical diagnosis of PTSD
Change will be examined from baseline through the end of treatment. For each participant it will be reported if there was a change in each participants clinician administered diagnostic assessment and the resulting severity rating for a PTSD diagnosis. This assessment will be used in conjunction with the ADIS-5 (outcome 2) to inform the presence or absence of clinical diagnoses at baseline and follow-up. Each has it's own metric, but can be used to show the presence or absence of a clinical level of the diagnosis. They cannot be combine into one variable unless a dichotomous score is calculated to indicate a clinical diagnosis more broadly is present versus absent.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2016 (estimated)
- Study startDec 2014
- Primary completion12 Feb 2019
- Study completion12 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- More trials run by Boston UniversityThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 71 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Cassidy Gutner, PhD, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02944994
- Sponsor's protocol ID
- H-33257
- Other IDs
- K23MH103396
- Status last verified
- Aug 2019
- First submitted
- 8 Apr 2016
- Last updated
- 14 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gutner CA, Song J, Canale CA, Suvak MK, Litwack SD, Niles BL, Stirman SW. A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans. Depress Anxiety. 2022 Dec;39(12):813-823. doi: 10.1002/da.23288. Epub 2022 Oct 18.
PubMed 36258655
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Unified Transdiagnostic Treatment in Routine Clinical Care
- ClinicalTrials.gov ID
- NCT02944994
- Acronym / sponsor ID
- H-33257
- Conditions
- Anxiety, Traumatic Stress Disorders, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 71 participants (actual)
- Lead sponsor
- Boston UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Dec 2014
- Primary completion
- 12 Feb 2019 (actual)
- Study completion
- 12 Feb 2019 (actual)
- First posted
- 26 Oct 2016 (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.
The purpose of this study is to examine effectiveness and implementation for the Unified Protocol for the Transdiagnostic Treatment of Emotional Disorders in trauma exposed veterans.
Detailed description
Anxiety and mood diagnoses are chronic and devastating with respect to costs to the individual and the healthcare system, and are more prevalent than any other class of disorders. When these disorders present concurrently, the significant public health implications and societal costs are intensified. Despite high rates of comorbidity and underlying mechanistic similarities between treatment protocols, single disorder evidence- based psychotherapy protocols for these disorders have traditionally been recommended to treat emotional disorders sequentially. Moreover, when clinicians are presented with complex case presentations, they are often unprepared to treat them and move away from evidence-based approaches, potentially increasing the burden on the mental health system. The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) is an innovative transdiagnostic protocol with promising evidence for successful treatment of emotional disorders, both for standalone and comorbid presentations, including the classification of not otherwise specified (NOS) disorders. To date, there have only been efficacy trials of the UP, which limit generalizability and do not address the larger public health impact and effectiveness in routine clinical care settings with both psychiatric and medical comorbidity. To address this critical limitation, the applicant proposes a pilot feasibility, acceptability, and tolerability study of the UP in patients with diverse psychiatric and medical comorbidity to manualized supportive therapy within a hospital. The deployment focused model (DFM) will inform design and statistical analyses. An additional aim includes determining the feasibility, acceptability, perceived fit and satisfaction of the UP in clinic settings through surveying and interviewing stakeholders in the system that are implementing the UP through the study. Consultation with stakeholders can minimize the time required to collect and assess fit within the larger system and, therefore, minimizes the time lag between science and practice in routine care settings. This study addresses an important public health concern by examining the effectiveness of the UP in a new population as a strategy for treatment of common and debilitating mental disorders in routine care settings. Furthermore, the proposed research aims will complement a comprehensive training plan to prepare the applicant to become an independent investigator with expertise in implementation science and effectiveness research. Results from the study will provide important information about whether or not this efficacious treatment can be effective, efficient, and ready for implementation in routine care settings in which psychiatric and medical comorbidity are common. This study will also serve as a model of deploying efficacious treatments into generalist clinics.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol | Experimental | Other: Unified protocolUnified Protocol-psychotherapy |
| Routine Care | Experimental | Other: Routine CareRoutine Care psychotherapy comparison |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- VA Boston Health Care Patient:
- Definition: Currently enrolled as a patient at VA Boston Healthcare System
- Diagnosis of an emotional disorder Definition: Diagnostic and Statistical Manual-5 (DSM-5) diagnosis of any emotional disorder (anxiety disorder, traumatic stress disorders, or unipolar depression)
- Cognitive Functioning:
- Definition: free of cognitive impairment demonstrated by ability to understand and provide consent
Key exclusion criteria (6 listed)
- Veteran Participant Exclusionary Criteria
- Current diagnosis of substance dependence (but not abuse)
- Primary diagnosis of bipolar disorder
- Current diagnosis of psychosis
- High suicidal risk (plan with intent)
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 protocolThis is a transdiagnostic cognitive behavioral therapy | Other | Unified Protocol |
| Routine CareThis arm will reflect typical care received in routine mental health care | Other | Routine Care |
Primary outcome
Barriers and facilitators that impact implementation of the intervention measured by the Consolidated Framework for Implementation Research (CFIR)
Time frame: One time assessment, occurring on 1 day, approximately 4 months after treatment initiation
These interviews will occur at one time point and will be analyzed with Qualitative Comparative Analyses guided by the Consolidated Framework for Implementation Research. Qualitative analyses are often descriptive in nature and a summary of common themes are reported to speak to factors impacting implementation of the intervention in this population. NVivo software will be used to aggregate the qualitative interviews from all participants and highlight the common themes across CFIR interviews
Change in clinician administered Anxiety Disorders Interview Scheduled will be used to generate clinical diagnoses for mental health disorders
Time frame: 7 months
Change will be examined from baseline through the end of treatment. For each participant it will be reported if there was a change in each participants clinician administered diagnostic assessment and the resulting clinician severity rating for each mental health diagnosis. This assessment will be used in conjunction with the CAPS-5 (outcome 3) to inform the presence or absence of clinical diagnoses at baseline and follow-up. Each has it's own metric, but can be used to show the presence or absence of a clinical level of the diagnosis
Change in Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) will be used to asses the presence or absence of a clinical diagnosis of PTSD
Time frame: 7 months
Change will be examined from baseline through the end of treatment. For each participant it will be reported if there was a change in each participants clinician administered diagnostic assessment and the resulting severity rating for a PTSD diagnosis. This assessment will be used in conjunction with the ADIS-5 (outcome 2) to inform the presence or absence of clinical diagnoses at baseline and follow-up. Each has it's own metric, but can be used to show the presence or absence of a clinical level of the diagnosis. They cannot be combine into one variable unless a dichotomous score is calculated to indicate a clinical diagnosis more broadly is present versus absent.
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 14 Aug 2019.
- Derived from this study: PubMed 36258655Gutner CA, Song J, Canale CA, Suvak MK, Litwack SD, Niles BL, Stirman SW. A pilot randomized effectiveness trial of the unified protocol in trauma-exposed veterans. Depress Anxiety. 2022 Dec;39(12):813-823. doi: 10.1002/da.23288. Epub 2022 Oct 18.
- Individual participant dataSharing planned: No
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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.
Cassidy Gutner, PhD 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 Unified protocol and Routine Care in people with Anxiety and Traumatic Stress Disorders, run by Boston 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 10 inclusion and 6 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 14 Aug 2019. 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?
Barriers and facilitators that impact implementation of the intervention measured by the Consolidated Framework for Implementation Research (CFIR) (time frame: One time assessment, occurring on 1 day, approximately 4 months after treatment initiation). The study lists 3 primary outcomes in all. 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 NCT02944994, which also lists 1 linked publication.
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 14 Aug 2019.