Anxiety DisordersNCT05120232
Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders
A study testing Unified Protocol and Modified Unified Protocol (UP+) in people with Anxiety Disorders and Depressive Disorder, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This two phase study is testing an online version of a transdiagnostic, cognitive behavioral therapy, against a modified version of that therapy emphasizing positive affect. The first phase of the trial will focus on content development for the modified therapy and the second phase will be a randomized control trial… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Disorders, Depressive Disorder
- What is being tested?
- Unified Protocol and Modified Unified Protocol (UP+)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2021to 16 Jan 2024
- 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
- Diagnosed with a DSM-5 anxiety, obsessive-compulsive, or depressive disorder
Who cannot join
- Acute risk factors (suicidal or homicidal ideation or clinical condition requiring immediate treatment);
- The individual is in treatment elsewhere for related issues; and/or
- The individual is considering changing their treatment and and/or psychotropic medication during the time period in which they would be enrolled in the study and/or
- The individual is unable or unwilling to commit to the study procedures.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Related Disorders - Boston University
Boston, Massachusetts, 02115
About this study
This two phase study is testing an online version of a transdiagnostic, cognitive behavioral therapy, against a modified version of that therapy emphasizing positive affect. The first phase of the trial will focus on content development for the modified therapy and the second phase will be a randomized control trial comparing the two.
Read the detailed description
Research shows that positive emotions can buffer against the effects of stress as well as contribute to overall well-being and functioning. People with emotional disorders, such as anxiety and depression, often report lower levels of positive emotions. However, to date, most existing treatment approaches for emotional disorders focus on regulating negative emotions, without explicitly focusing on positive emotions.
The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has been shown to be effective for treating emotional disorders. The UP targets negative emotions and helps people respond to their emotions in ways that are more helpful for them and in line with their goals. In its current form, the UP does not explicitly target positive emotions, but some research suggests that individuals treated with the UP and other cognitive-behavioral treatments experience some improvement in positive affect.
In the current study, the researchers will create a modified version of the UP (called the UP+) delivered entirely on an online platform that will include exercises specifically designed to enhance positive emotions. Then, the researchers will evaluate the UP+ in a small sample of participants to examine acceptability and feasibility and will then use this information to continue to refine the protocol. Finally, the researchers will conduct a randomized controlled trial to assess the efficacy of the UP+. Participants diagnosed with emotional disorders will be randomized to either receive the UP or the UP+ delivered on an online platform and will be assessed on a range of outcomes, including positive and negative affect, psychological symptoms, and functional outcomes.
- Conditions
- Anxiety Disorders, Depressive Disorder
- Being tested
- Unified Protocol, Modified Unified Protocol (UP+)
- Medical subject headings
- Anxiety Disorders, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified ProtocolBehavioural
A transdiagnostic, cognitive behavioral therapy.
Modified Unified Protocol (UP+)Behavioural
A transdiagnostic, cognitive behavioral therapy.
| Study group | Role | What they receive |
|---|---|---|
| Unified Protocol (UP) | Active comparator | The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has been shown to be effective for treating emotional disorders. The UP targets negative emotions and helps people respond to their emotions in ways that are more helpful for them and in line with their goals. This will be delivered entirely on an online platform. Receives: Behavioral: Unified Protocol |
| Modified Unified Protocol (UP+) | Experimental | A modified version of the UP (called the UP+) delivered entirely on an online platform that will include exercises specifically designed to enhance positive emotions. Receives: Behavioral: Modified Unified Protocol (UP+) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual-5 (ADIS-5) Score
This semi-structured, diagnostic clinical interview focuses on Diagnostic and Statistical Manual-5 diagnoses of anxiety disorders and their accompanying mood states, somatoform disorders, and substance and alcohol use. 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. 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 diagnostic criteria. Inquiries about suicidal ideation are part of this interview. This measure has demonstrated excellent to acceptable interrater reliability for the anxiety and mood disorders (Brown, Di Nardo, et al., 2001).
Measured: Baseline, 12-weeks following baseline, 3 months following the treatment phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start8 Mar 2021
- Primary completion1 Jul 2023
- Study completion16 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kentucky, Harvard School of Public Health (HSPH)
- Responsible party
- Sponsor
- Investigators
- Todd Farchione, Ph.D., Principal investigator, Center for Anxiety Related Disorders at Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120232
- Sponsor's protocol ID
- 61245
- Other IDs
- 5724E
- Status last verified
- Feb 2025
- First submitted
- 8 Sep 2020
- Last updated
- 7 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Long LJ, Spencer-Laitt D, Hey AJ, Boschulte MR, Teplow DA, Moreno-Villamizar JD, Williams AL, Eustis EH, Trudel-Fitzgerald C, Farchione TJ. Efficacy of a modified digital unified protocol targeting both positive and negative emotion regulation: A randomized clinical trial. J Consult Clin Psychol. 2026 Jun;94(6):377-392. doi: 10.1037/ccp0001010.
PubMed 42406487Teplow D, Spencer-Laitt D, Long LJ, Hey AJ, Moreno JD, Farchione TJ. Strengths use and emotional disorder symptom reduction during a transdiagnostic cognitive behavioral therapy: A random-intercept cross-lagged panel model study. Psychotherapy (Chic). 2025 Jun;62(2):220-234. doi: 10.1037/pst0000553. Epub 2024 Nov 21.
PubMed 39570688
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders
- ClinicalTrials.gov ID
- NCT05120232
- Acronym / sponsor ID
- 61245
- Conditions
- Anxiety Disorders, Depressive Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- University of Kentucky, Harvard School of Public Health (HSPH)
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 16 Jan 2024 (actual)
- First posted
- 15 Nov 2021 (actual)
- 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.
This two phase study is testing an online version of a transdiagnostic, cognitive behavioral therapy, against a modified version of that therapy emphasizing positive affect. The first phase of the trial will focus on content development for the modified therapy and the second phase will be a randomized control trial comparing the two.
Detailed description
Research shows that positive emotions can buffer against the effects of stress as well as contribute to overall well-being and functioning. People with emotional disorders, such as anxiety and depression, often report lower levels of positive emotions. However, to date, most existing treatment approaches for emotional disorders focus on regulating negative emotions, without explicitly focusing on positive emotions.
The Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has been shown to be effective for treating emotional disorders. The UP targets negative emotions and helps people respond to their emotions in ways that are more helpful for them and in line with their goals. In its current form, the UP does not explicitly target positive emotions, but some research suggests that individuals treated with the UP and other cognitive-behavioral treatments experience some improvement in positive affect.
In the current study, the researchers will create a modified version of the UP (called the UP+) delivered entirely on an online platform that will include exercises specifically designed to enhance positive emotions. Then, the researchers will evaluate the UP+ in a small sample of participants to examine acceptability and feasibility and will then use this information to continue to refine the protocol. Finally, the researchers will conduct a randomized controlled trial to assess the efficacy of the UP+. Participants diagnosed with emotional disorders will be randomized to either receive the UP or the UP+ delivered on an online platform and will be assessed on a range of outcomes, including positive and negative affect, psychological symptoms, and functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unified Protocol (UP) | Active comparator | Behavioral: Unified ProtocolThe Unified Protocol (UP) is a transdiagnostic, cognitive-behavioral therapy that has been shown to be effective for treating emotional disorders. The UP targets negative emotions and helps people respond to their emotions in ways that are more helpful for them and in line with their goals. This will be delivered entirely on an online platform. |
| Modified Unified Protocol (UP+) | Experimental | Behavioral: Modified Unified Protocol (UP+)A modified version of the UP (called the UP+) delivered entirely on an online platform that will include exercises specifically designed to enhance positive emotions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosed with a DSM-5 anxiety, obsessive-compulsive, or depressive disorder
Key exclusion criteria (4 listed)
- Acute risk factors (suicidal or homicidal ideation or clinical condition requiring immediate treatment);
- The individual is in treatment elsewhere for related issues; and/or
- The individual is considering changing their treatment and and/or psychotropic medication during the time period in which they would be enrolled in the study and/or
- The individual is unable or unwilling to commit to the study procedures.
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 ProtocolA transdiagnostic, cognitive behavioral therapy. | Behavioural | Unified Protocol (UP) |
| Modified Unified Protocol (UP+)A transdiagnostic, cognitive behavioral therapy. | Behavioural | Modified Unified Protocol (UP+) |
Primary outcome
Change in Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual-5 (ADIS-5) Score
Time frame: Baseline, 12-weeks following baseline, 3 months following the treatment phase
This semi-structured, diagnostic clinical interview focuses on Diagnostic and Statistical Manual-5 diagnoses of anxiety disorders and their accompanying mood states, somatoform disorders, and substance and alcohol use. 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. 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 diagnostic criteria. Inquiries about suicidal ideation are part of this interview. This measure has demonstrated excellent to acceptable interrater reliability for the anxiety and mood disorders (Brown, Di Nardo, et al., 2001).
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 7 Feb 2025.
- Derived from this study: PubMed 42406487Long LJ, Spencer-Laitt D, Hey AJ, Boschulte MR, Teplow DA, Moreno-Villamizar JD, Williams AL, Eustis EH, Trudel-Fitzgerald C, Farchione TJ. Efficacy of a modified digital unified protocol targeting both positive and negative emotion regulation: A randomized clinical trial. J Consult Clin Psychol. 2026 Jun;94(6):377-392. doi: 10.1037/ccp0001010.
- Derived from this study: PubMed 39570688Teplow D, Spencer-Laitt D, Long LJ, Hey AJ, Moreno JD, Farchione TJ. Strengths use and emotional disorder symptom reduction during a transdiagnostic cognitive behavioral therapy: A random-intercept cross-lagged panel model study. Psychotherapy (Chic). 2025 Jun;62(2):220-234. doi: 10.1037/pst0000553. Epub 2024 Nov 21.
- 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.
Todd Farchione, Ph.D. principal investigator
Center for Anxiety Related Disorders at 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 Modified Unified Protocol (UP+) in people with Anxiety Disorders and Depressive Disorder, 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 4 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 7 Feb 2025. 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?
Change in Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual-5 (ADIS-5) Score (time frame: Baseline, 12-weeks following baseline, 3 months following the treatment phase). 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 NCT05120232, which also lists 2 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 7 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.