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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment as usual plus UP CBT | Experimental | Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT |
|
| Treatment as usual | Active Comparator | Existing psychiatrist-administered psychopharmacotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UP CBT | Behavioral | The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Six months |
| 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. | Six months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex | 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. |
Inclusion Criteria:
generalized anxiety disorder, panic disorder, or social phobia.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital Bipolar Clinic and Research Program | Boston | Massachusetts | 02114 | United States |
Participants were excluded from the trial before assignment to study arms based on exclusion criteria related to diagnosis and unstable medication regime.
37 were invited to consent. 34 consented to be screened for inclusion. 5 did not meet study inclusion criteria thus were not randomized (1 not on a stabilized medication; 1 did not meet criteria for anxiety disorder; 2 were currently substance dependent; 1 reported psychosis). 29 were randomized to TAU or TAU plus 18 sessions of CBT (UP+TAU).
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment as Usual Plus UP CBT | Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders |
| FG001 | Treatment as Usual | Existing psychiatrist-administered psychopharmacotherapy Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment as Usual Plus UP CBT | Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders |
| BG001 | Treatment as Usual |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis. | Posted | Mean | Standard Deviation | Units on scale | Six months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment as Usual Plus UP CBT | Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT UP CBT: The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kristen Ellard, PhD | Massachusetts General Hospital | 617-726-6422 | kellard@partners.org |
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| ID | Term |
|---|---|
| D001714 | Bipolar Disorder |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D000068105 | Bipolar and Related Disorders |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Treatment as usual | Drug | Existing optimized pharmacotherapy as delivered by treating psychiatrist |
|
| Six months |
| 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. | Six Months |
| 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. | 6 months |
| 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. | 6 months |
| 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. | 6 months |
| Six Months |
Existing psychiatrist-administered psychopharmacotherapy Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Difficulties in Emotion Regulation Scale (DERS) | Emotion regulation skills were assessed at baseline using a self-report questionnaire 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 (minimum score 1, maximum score 6). Higher scores indicate greater impairment in emotion regulation skills. | Mean | Standard Deviation | units on a scale |
|
| Affective Control Scale (ACS) | Perceived controllability of emotions was assessed at baseline using the the self-report Affective Control Scale (ACS) a 42-item Likert-type scale (1-7) calculated by averaging scores across all items (minimum score 1, maximum score 7). Higher scores indicate greater impairment and less perceived control of emotions. | Mean | Standard Deviation | units on a scale |
|
| Anxiety Sensitivity Index (ASI) | Anxiety sensitivity was assessed at baseline using the self-report Anxiety Sensitivity Index questionnaire (ASI) a 16-item likert-type scale (0-4) calculated by summing scores across items (minimum score 0, maximum score 64). Higher scores indicate greater impairment. | Mean | Standard Deviation | units on a scale |
|
| NEO Five Factor Inventory of Personality, Neuroticism Subscale (NEO-FFI-N) | Neuroticism was assessed at baseline using the NEO Five Factor Personality Inventory Neuroticism Scale (NEO-FFI-N) which is a subscale of the NEO-FFI, a 60-item scale (0-4) calculated by summing scores for each subscale. Only the 12-item Neuroticism subscale is included in this study. Higher scores indicate greater impairment. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Treatment as Usual | Existing psychiatrist-administered psychopharmacotherapy Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist |
|
|
|
| Primary | 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. | ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis. | Posted | Mean | Standard Deviation | Units on scale | Six months |
|
|
|
|
| Secondary | 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. | ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis. | Posted | Mean | Standard Deviation | Units on scale | Six months |
|
|
|
|
| Secondary | 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. | ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis. | Posted | Mean | Standard Error | beta coefficients | Six Months |
|
|
|
|
| Secondary | 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. | ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis. | Posted | Mean | Standard Error | beta coefficients | 6 months |
|
|
|
|
| Secondary | 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. | ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis. | Posted | Mean | Standard Error | beta coefficients | 6 months |
|
|
|
|
| Secondary | 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. | ITT analysis, data imputed to account for 30% missing data. A total of 28 people were included in the ITT analysis - one TAU participant initiated CBT through a private practitioner mid-study (an exclusion criteria) and was subsequently excluded from the analysis. | Posted | Mean | Standard Error | beta coefficients | 6 months |
|
|
|
|
| Other Pre-specified | Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex | 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. | Participating in the fMRI portion of the study was optional. A total of 15 participants consented to participate in fMRI portion (7 TAU+UP, 8 TAU). Data from all 15 subjects were analyzed. | Posted | Mean | Standard Error | beta coefficient | Six Months |
|
|
|
|
| 1 |
| 13 |
| 0 |
| 13 |
| EG001 | Treatment as Usual | Existing psychiatrist-administered psychopharmacotherapy Treatment as usual: Existing optimized pharmacotherapy as delivered by treating psychiatrist | 0 | 16 | 0 | 16 |
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| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| Month 3 |
|
| Month 4 |
|
| Month 5 |
|
| Month 6 |
|
| Regression, Linear |
| .03 |
| Other |
| Regression, Linear |
| 0.03 |
| Other |
| Regression, Linear |
| 0.37 |
| Other |
| Regression, Linear |
| .04 |
| Other |
Fisher's z-transformed values for functional connectivity between anterior insula and ventrolateral prefrontal cortex were entered in separate treatment group-specific linear regression models as the independent variable with change in primary outcomes (HAM-D) as dependent variable.
| Regression, Linear |
| .14 |
| Other |