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NCT01892306 · ClinicalTrials.gov registry record · NA
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
A NA study, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
NCT01892306: Completed NA study, sponsored by Massachusetts General Hospital.
NCT01892306 is a NA study that has completed, run by Massachusetts General Hospital. The registered enrollment target is 34 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01892306, a NA study, has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
Study Summary
The specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders \[Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP)\], for the treatment of patients with bipolar I disorder (BD-I) and comorbid anxiety. The study will compare treatment-as-usual with pharmacotherapy (TAU) plus 18 one-hour sessions of treatment with the UP to TAU alone. Patients in both treatment conditions will be followed over a 12-month period and will be assessed monthly to track changes in mood, anxiety and emotion-related symptoms; functional impairment; and relapse rates. Data on the acceptability of the treatment will be gathered concurrently through monthly patient self-reported ratings of treatment satisfaction, and by tracking rates of acceptance for randomization into the study, number of completed sessions, and dropout rates. The study will examine: 1) whether combined cognitive behavioral treatment (UP) for BD-I and comorbid anxiety disorders is an acceptable and feasible approach to treatment; 2) whether treatment with the UP for BD-I and comorbid anxiety disorders as an adjunct to pharmacotherapy treatment-as-usual (TAU) leads to greater symptom reduction and reduced functional impairment than pharmacotherapy alone, 3) whether treatment for BD-I and comorbid anxiety disorders with the UP improves relapse rates over a 6-month follow-up relative to TAU; and 4) whether reduction in symptoms, relapse rates, and functional impairment are mediated by changes in emotion regulation skills. The broader aim of this study is to address the need for improved treatments for bipolar disorder.
Interventions
- DRUG Treatment as usual
- BEHAVIORAL UP CBT
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2013-06 |
| Est. Completion | 2014-12 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01892306
The ClinicalTrials.gov registry entry for NCT01892306 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Treatment as usual is the first listed.
NCT01892306 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01892306 about?
NCT01892306 is a clinical study titled "Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder". The specific goal of this research study is to investigate the feasibility, acceptability, and preliminary efficacy of a transdiagnostic, cognitive-behavioral therapy developed specifically to target common core processes across mood and anxiety disorders \[Unified Protocol for Transdiagnostic Treat...
What is the current status of trial NCT01892306?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2013-06. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01892306?
The interventions under investigation include: Treatment as usual (DRUG), UP CBT (BEHAVIORAL).
Who is sponsoring clinical trial NCT01892306?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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