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

NCT05120232 | Completed

• 2 other identifiers: 612455724E
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety Disorders; Depressive Disorder

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, 12-weeks following baseline, 3 months following the treatment phase

Other Outcomes (3)

• Change in Positive and Negative Affect Schedule Expanded Form (PANAS-X) Score

  Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase

• Change in Savoring Beliefs Inventory (SBI) Score

  Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase

• Change in Flourish Index (FI) Score

  Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase

Study Arms (2)

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.

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.

Behavioral: Modified Unified Protocol (UP+)

Interventions

Unified Protocol BEHAVIORAL

A transdiagnostic, cognitive behavioral therapy.

Unified Protocol (UP)

Modified Unified Protocol (UP+) BEHAVIORAL

A transdiagnostic, cognitive behavioral therapy.

Modified Unified Protocol (UP+)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boston University Charles River Campus: lead
• University of Kentucky: collaborator
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

Center for Anxiety and Related Disorders - Boston University

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• Teplow 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.

  PMID: 39570688 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder

Condition Hierarchy (Ancestors)

Mental Disorders; Mood Disorders

Study Officials

• Todd Farchione, Ph.D.

  Center for Anxiety Related Disorders at Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 8, 2020
• First Posted: November 15, 2021
• Study Start: March 8, 2021
• Primary Completion: July 1, 2023
• Study Completion: January 16, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)