Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
| Status: | Recruiting |
|---|---|
| Conditions: | Anxiety, Psychiatric, Bipolar Disorder |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/13/2015 |
| Start Date: | June 2013 |
Transdiagnostic Treatment 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 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.
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.
Inclusion Criteria:
- 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 Criteria:
- 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
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