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Unified Protocol for Generalized Anxiety Disorder

N/A

Recruiting

Led By Todd Farchione, PhD

Research Sponsored by Boston University Charles River Campus

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change from baseline following 16-week treatment

Summary

This trial will help to assess whether the Unified Protocol, a cognitive-behavioral therapy, is more effective than a computerized alcohol reduction program in reducing alcohol consumption in patients with comorbid alcohol use disorders and anxiety disorders.

Eligible Conditions

Generalized Anxiety Disorder
Alcoholism
Anxiety Disorders

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline following 16-week treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline following 16-week treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline following 16-week treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Number of Drinks Consumed Per Day

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Unified ProtocolActive Control1 Intervention

The Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) consists of 5 core skills modules based on cognitive behavioral treatment elements of proven effectiveness. As noted above, these core skills modules were designed to target (and have been shown to address) negative emotionality and aversive reactivity to emotional experiences when they occur (Boswell et al., 2013; Carl et al., 2014; Sauer-Zavala et al., 2012). These modules are preceded by an introductory session that reviews the patient's presenting symptoms and provides a therapeutic rationale, as well as a module on motivational enhancement. A final module consists of relapse prevention. As the treatment proceeds, the domains of thoughts, feelings, and behaviors are each explored in detail, focusing specifically on elucidating dysfunctional emotion regulation strategies that the patient has developed over time within each of these domains, and teaching patients more adaptive emotion regulation skills.

Group II: Take ControlPlacebo Group1 Intervention

TC is a psychotherapy platform derived from the National Institute on Alcohol Abuse and Alcoholism's (NIAAA) self-help approach, Rethinking Drinking. In this study, TC, originally designed as a computerized treatment has been modified to be administered by the therapist to control for effects that may be related to patient-therapist interaction (as opposed to elements of the treatment itself). Specifically, on a weekly basis, therapists will review material from TC and offer general advice on implementation of the alcohol reduction skills in daily life.

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