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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Anxiety Disorders, Depressive Disorder

Intervention / Treatment
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* Behavioral: Unified Protocol
* Behavioral: Modified Unified Protocol (UP+)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Unified Protocol (UP)<br>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<br>* A transdiagnostic, cognitive behavioral therapy.<br>|
| Experimental: Modified Unified Protocol (UP+)<br>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+)<br>* A transdiagnostic, cognitive behavioral therapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |