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

NCT ID: NCT05120232

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-08
• Study Completion Date: 2024-01-16

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.

Conditions

Anxiety Disorders; Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Unified Protocol (UP)

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.

Group Type: ACTIVE_COMPARATOR

Unified Protocol

Intervention Type: BEHAVIORAL

A transdiagnostic, cognitive behavioral therapy.

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.

Group Type: EXPERIMENTAL

Modified Unified Protocol (UP+)

Intervention Type: BEHAVIORAL

A transdiagnostic, cognitive behavioral therapy.

Interventions

Unified Protocol

A transdiagnostic, cognitive behavioral therapy.

Intervention Type: BEHAVIORAL

Modified Unified Protocol (UP+)

A transdiagnostic, cognitive behavioral therapy.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kentucky

OTHER

Sponsor Role: collaborator

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Boston University Charles River Campus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Farchione, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Center for Anxiety Related Disorders at Boston University

Locations

Center for Anxiety and Related Disorders - Boston University

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 39570688 (View on PubMed)

Other Identifiers

5724E

Identifier Type: OTHER

Identifier Source: secondary_id

61245

Identifier Type: -

Identifier Source: org_study_id