Status:
COMPLETED
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Bipolar Disorder
Anxiety Disorders
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- Men and women age 18-65
- DSM-IV diagnosis of bipolar I disorder and at least one of three additional anxiety disorders:
- generalized anxiety disorder, panic disorder, or social phobia.
- HAM-D-17 score \<16 (i.e. depressive symptoms)
- YMRS score \< 12 (i.e. no or very low manic symptoms)
- Current, stabilized (\> 3 months) pharmacotherapy treatment under the care of a psychiatrist consisting of optimized, stable maintenance pharmacotherapy at maximum tolerated dosages according to Texas Implementation of Medication Algorithm.
Exclusion
- Active suicidality (HAM-D-17 suicide item #3 score \> 3) in the past 2 months. Potential participants scoring 3 or higher on the HAM-D-17 suicide item will be immediately evaluated by the PI and Sponsor and referred to a higher level of care if clinically indicated.
- DSM-IV bipolar I disorder subtype rapid cycling
- DSM-IV manic or mixed episode in the past 2 months
- DSM-IV major depressive episode in the past 2 months
- Psychotropic medication not in accordance with the revised Texas Implementation of Medication Algorithm
- Current Pregnancy
- Medical illness or non-psychiatric medical treatment that would likely interfere with study participation.
- Neurologic disorder, previous ECT, or history of head trauma (i.e. known structural brain lesion)
- Current or past history of selected DSM-IV Axis I disorders other than bipolar disorder including: organic mental disorder, substance abuse within the past 12 months and/or history of substance abuse for \> 1 year; current substance dependence (including alcohol), as assessed by the Structured Clinical Interview for DSM-IV-TR, Substance Use Disorders (Section E); schizophrenia, delusional disorder, psychotic disorders not otherwise specified, obsessive compulsive disorder and posttraumatic stress disorder (due to low prevalence of \~6.5% each).
- Concurrent psychotherapy other than cognitive-behavioral therapy as provided in this study (to rule out other uncontrolled effects of concurrent psychotherapies)
- Presence of metallic implants that would interfere with safety during fMRI scanning (i.e. cardiac pacemaker, metal plates, etc.)
- Claustrophobia
Key Trial Info
Start Date :
June 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT01892306
Start Date
June 1 2013
End Date
December 1 2014
Last Update
May 12 2017
Active Locations (1)
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1
Massachusetts General Hospital Bipolar Clinic and Research Program
Boston, Massachusetts, United States, 02114