Back to resultsPilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
Primary Purpose
Bipolar Disorder, Anxiety Disorders
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
UP CBT
Treatment as usual
Sponsored by
About this trial
This is an interventional treatment trial for Bipolar Disorder
Eligibility Criteria
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
Sites / Locations
- Massachusetts General Hospital Bipolar Clinic and Research Program
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Treatment as usual plus UP CBT
Treatment as usual
Arm Description
Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
Existing psychiatrist-administered psychopharmacotherapy
Outcomes
Primary Outcome Measures
Reductions Over Time in Anxiety Symptoms as Measured by Hamilton Anxiety Rating Scale
The Hamilton Anxiety Rating Scale (HAM-A) is a well-validated clinician administered rating of anxiety-related symptoms. Ratings are made on a 0 (no symptoms) to 4 (most severe in frequency/duration/interference/distress) for each item (14 items), with a minimum score of 0 and a maximum score of 56 calculated by summing scores of all 14 items. Higher scores indicate greater impairment.
Reductions Over Time in Depression Symptoms as Measured by Hamilton Depression Rating Scale (HAM-D)
The Hamilton Depression Rating Scale (HAM-D) is a well-validated clinician administered rating of depression-related symptoms. Scores are calculated by summing scores across all 17-items, with a minimum score of 0 and a maximum score of 54. Higher scores indicate greater impairment.
Secondary Outcome Measures
Treatment Acceptability as Measured by Client Satisfaction Questionnaire (CSQ)
The Client Satisfaction Questionnaire (CSQ) is an 8-item scale that assesses perceptions of acceptability and quality of outpatient treatment. Ratings are made on a 1 (poor) to 4 (excellent) scale for each item and then summed for a total score, with a minimum score of 8 and a maximum score of 32. Higher scores indicate greater satisfaction with treatment.
Association Between Anxiety Symptom Change (HAM-A) and Difficulties in Emotion Regulation Scale (DERS)
Emotion regulation skills were assessed using a measure of emotion regulation (Difficulties in Emotion Regulation Scale- DERS), a 36-item Likert-type scale (1-6) calculated by averaging scores across all items. See Baseline Characteristics for baseline DERS score. See Primary Outcome Measure for a description of HAM-A.
Association Between Anxiety Symptom Change (HAM-A) and Reaction to Emotions (Affective Control Scale-ACS)
Reactions to emotions, were assessed using the Affective Control Scale, or ACS, a 42-item Likert-type scale (1-7) calculated by averaging scores across all items. See Baseline Characteristics for baseline ACS score. See Primary Outcome Measure for description of HAM-A.
Association Between Anxiety Symptom Change (HAM-A) and Anxiety Sensitivity (Anxiety Sensitivity Index-ASI)
Anxiety sensitivity, were assessed using the Anxiety Sensitivity Index, or ASI, a 16-item Likert-type scale (0-4) calculated by summing scores across items. See Baseline Characteristics for baseline ASI scores. See Primary Outcome Measures for a description of HAM-A.
Association Between Anxiety Symptom Change (HAM-A) and Neuroticism (NEO Five-Factor Inventory- NEO-FFI-N)
Neuroticism was assessed using the NEO Five Factor Inventory (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item Likert-type scale (1-5) calculated by summing scores for each subscale. Only the 15-item Neuroticism subscale is included in this study. See Baseline Characteristics for baseline NEO-FFI-N. See Primary Outcome Measure for description of HAM-A.
Full Information
NCT ID
NCT01892306
First Posted
July 1, 2013
Last Updated
May 10, 2017
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01892306
Brief Title
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
Official Title
Transdiagnostic Treatment for Anxiety and Bipolar I Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bipolar Disorder, Anxiety Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual plus UP CBT
Arm Type
Experimental
Arm Description
Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Existing psychiatrist-administered psychopharmacotherapy
Intervention Type
Behavioral
Intervention Name(s)
UP CBT
Other Intervention Name(s)
Unified Protocol (UP) for transdiagnostic treatment of emotional disorders
Intervention Description
The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders
Intervention Type
Drug
Intervention Name(s)
Treatment as usual
Intervention Description
Existing optimized pharmacotherapy as delivered by treating psychiatrist
Primary Outcome Measure Information:
Title
Reductions Over Time in Anxiety Symptoms as Measured by Hamilton Anxiety Rating Scale
Description
The Hamilton Anxiety Rating Scale (HAM-A) is a well-validated clinician administered rating of anxiety-related symptoms. Ratings are made on a 0 (no symptoms) to 4 (most severe in frequency/duration/interference/distress) for each item (14 items), with a minimum score of 0 and a maximum score of 56 calculated by summing scores of all 14 items. Higher scores indicate greater impairment.
Time Frame
Six months
Title
Reductions Over Time in Depression Symptoms as Measured by Hamilton Depression Rating Scale (HAM-D)
Description
The Hamilton Depression Rating Scale (HAM-D) is a well-validated clinician administered rating of depression-related symptoms. Scores are calculated by summing scores across all 17-items, with a minimum score of 0 and a maximum score of 54. Higher scores indicate greater impairment.
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Treatment Acceptability as Measured by Client Satisfaction Questionnaire (CSQ)
Description
The Client Satisfaction Questionnaire (CSQ) is an 8-item scale that assesses perceptions of acceptability and quality of outpatient treatment. Ratings are made on a 1 (poor) to 4 (excellent) scale for each item and then summed for a total score, with a minimum score of 8 and a maximum score of 32. Higher scores indicate greater satisfaction with treatment.
Time Frame
Six months
Title
Association Between Anxiety Symptom Change (HAM-A) and Difficulties in Emotion Regulation Scale (DERS)
Description
Emotion regulation skills were assessed using a measure of emotion regulation (Difficulties in Emotion Regulation Scale- DERS), a 36-item Likert-type scale (1-6) calculated by averaging scores across all items. See Baseline Characteristics for baseline DERS score. See Primary Outcome Measure for a description of HAM-A.
Time Frame
Six Months
Title
Association Between Anxiety Symptom Change (HAM-A) and Reaction to Emotions (Affective Control Scale-ACS)
Description
Reactions to emotions, were assessed using the Affective Control Scale, or ACS, a 42-item Likert-type scale (1-7) calculated by averaging scores across all items. See Baseline Characteristics for baseline ACS score. See Primary Outcome Measure for description of HAM-A.
Time Frame
6 months
Title
Association Between Anxiety Symptom Change (HAM-A) and Anxiety Sensitivity (Anxiety Sensitivity Index-ASI)
Description
Anxiety sensitivity, were assessed using the Anxiety Sensitivity Index, or ASI, a 16-item Likert-type scale (0-4) calculated by summing scores across items. See Baseline Characteristics for baseline ASI scores. See Primary Outcome Measures for a description of HAM-A.
Time Frame
6 months
Title
Association Between Anxiety Symptom Change (HAM-A) and Neuroticism (NEO Five-Factor Inventory- NEO-FFI-N)
Description
Neuroticism was assessed using the NEO Five Factor Inventory (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item Likert-type scale (1-5) calculated by summing scores for each subscale. Only the 15-item Neuroticism subscale is included in this study. See Baseline Characteristics for baseline NEO-FFI-N. See Primary Outcome Measure for description of HAM-A.
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex
Description
Resting state functional magnetic resonance imaging (rsfMRI) data (non-task, eyes opened) was acquired to investigate anterior insula and ventrolateral prefrontal cortex functional connectivity as a predictor of change on depression (HAM-D). See primary outcome description of HAM-D.
Time Frame
Six Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Massachusetts General Hospital Bipolar Clinic and Research Program
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder
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