Clinical trial NCT05120232: 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
Overall status: COMPLETED
Phase: NA
Conditions: Anxiety Disorders
Depressive Disorder
Lead sponsor: Boston University Charles River Campus
Sponsor class: OTHER
Collaborators: name: University of Kentucky
name: Harvard School of Public Health (HSPH)
First posted: 2021-11-15
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change in Anxiety and Related Disorders Interview Schedule for Diagnostic and Statistical Manual-5 (ADIS-5) Score
timeFrame: Baseline, 12-weeks following baseline, 3 months following the treatment phase
Secondary outcomes:
Other outcomes:
measure: Change in Positive and Negative Affect Schedule Expanded Form (PANAS-X) Score
timeFrame: Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase
measure: Change in Savoring Beliefs Inventory (SBI) Score
timeFrame: Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase
measure: Change in Flourish Index (FI) Score
timeFrame: Baseline, every week through 12-weeks following baseline, 3 months following the treatment phase
Locations:
city: Boston
country: United States
facility: Center for Anxiety and Related Disorders - Boston University
state: Massachusetts
Study officials:
affiliation: Center for Anxiety Related Disorders at Boston University
name: Todd Farchione, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: