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Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders

Primary Purpose

Anxiety Disorders, Depressive Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Unified Protocol
Modified Unified Protocol (UP+)
Sponsored by
Boston University Charles River Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Diagnosed with a DSM-5 anxiety, obsessive-compulsive, or depressive disorder

Exclusion Criteria:

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 unable or unwilling to commit to the study procedures.

Sites / Locations

  • Center for Anxiety and Related Disorders - Boston UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Unified Protocol (UP)

Modified Unified Protocol (UP+)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Full Information

First Posted
September 8, 2020
Last Updated
January 23, 2023
Sponsor
Boston University Charles River Campus
Collaborators
University of Kentucky, Harvard School of Public Health (HSPH)
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1. Study Identification

Unique Protocol Identification Number
NCT05120232
Brief Title
Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders
Official Title
Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
July 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston University Charles River Campus
Collaborators
University of Kentucky, Harvard School of Public Health (HSPH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unified Protocol (UP)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Modified Unified Protocol (UP+)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Unified Protocol
Intervention Description
A transdiagnostic, cognitive behavioral therapy.
Intervention Type
Behavioral
Intervention Name(s)
Modified Unified Protocol (UP+)
Intervention Description
A transdiagnostic, cognitive behavioral therapy.
Primary Outcome Measure Information:
Title
Change in Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual-5 (ADIS-5) Score
Description
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).
Time Frame
Baseline, 12-weeks following baseline, 3 months following the treatment phase
Other Pre-specified Outcome Measures:
Title
Change in Positive and Negative Affect Schedule Expanded Form (PANAS-X) Score
Description
The PANAS-X is a brief, reliable and valid measure of positive and negative affect. It consists of 20 feeling or emotion words (e.g., interested, upset, nervous). Respondents rate each emotion word on a scale ranging from 1 = very slightly or not at all to 5 = extremely, indicating the extent to which they experience that emotion or feeling in general. The PANAS-X has shown excellent convergent and discriminant correlations with lengthier measures of underlying mood factors and is a widely used measure of state negative affect (Watson et al., 1988).
Time Frame
Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase
Title
Change in Savoring Beliefs Inventory (SBI) Score
Description
The SBI is a measure of one's tendency to savor or dampen positive emotions (Bryant, F. B. 2003). It includes distinctions among future, present, and past focused forms of savouring. The SBI includes 24 items with 4 positively-worded and 4 negatively-worded items for each of the three temporal forms of savoring (rated on a 7-point scale from 1 = strongly agree to 7 = strongly disagree) . Overall, the SBI is a valid and reliable measure of individuals' beliefs about their capacity to savour positive experiences (Bryant 2003).
Time Frame
Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase
Title
Change in Flourish Index (FI) Score
Description
The FI is a measurement approach to human flourishing, based around five central domains: happiness and life satisfaction, mental and physical health, meaning and purpose, character and virtue, and close social relationships. The FI consists of 10 questions on a 10 point Likert scale (with 0 = strongly disagree to 10 = strongly agree) (VanderWeele, 2017). The FI has demonstrated good internal consistency and evidence of validity and reliability (Węziak-Białowolska et al, 2019).
Time Frame
Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with a DSM-5 anxiety, obsessive-compulsive, or depressive disorder Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Todd Farchione, Ph.D.
Phone
617-353-9609
Email
tfarchio@bu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Audrey Hey
Phone
(617) 353-2000
Email
ajhey@bu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Todd Farchione, Ph.D.
Organizational Affiliation
Center for Anxiety Related Disorders at Boston University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center for Anxiety and Related Disorders - Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Todd J Farchione, PhD
Phone
627-353-9610

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Flourishing and Virtue in Cognitive-Behavioral Therapy for Anxiety and Depressive Disorders

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