Pilot Study of Cognitive Behavioral Therapy for Anxiety and Bipolar I Disorder

NCT01892306 | Completed Results

• 1 other identifier: 1F32MH098490-01
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Bipolar Disorder; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (5)

• Treatment Acceptability as Measured by Client Satisfaction Questionnaire (CSQ)

  Six months

• Association Between Anxiety Symptom Change (HAM-A) and Difficulties in Emotion Regulation Scale (DERS)

  Six Months

• Association Between Anxiety Symptom Change (HAM-A) and Reaction to Emotions (Affective Control Scale-ACS)

  6 months

• Association Between Anxiety Symptom Change (HAM-A) and Anxiety Sensitivity (Anxiety Sensitivity Index-ASI)

  6 months

• Association Between Anxiety Symptom Change (HAM-A) and Neuroticism (NEO Five-Factor Inventory- NEO-FFI-N)

  6 months

Other Outcomes (1)

• Association Between Change on Depression (HAM-D) and Baseline Resting State Functional Connectivity of Anterior Insula and Ventrolateral Prefrontal Cortex

  Six Months

Study Arms (2)

Treatment as usual plus UP CBT

EXPERIMENTAL

Existing psychiatrist-administered psychopharmacotherapy plus weekly transdiagnostic CBT

Behavioral: UP CBT

Treatment as usual

ACTIVE COMPARATOR

Existing psychiatrist-administered psychopharmacotherapy

Drug: Treatment as usual

Interventions

UP CBT BEHAVIORAL

The UP is an 18-session weekly cognitive behavioral intervention for anxiety and mood disorders

Also known as: Unified Protocol (UP) for transdiagnostic treatment of emotional disorders

Treatment as usual plus UP CBT

Treatment as usual DRUG

Existing optimized pharmacotherapy as delivered by treating psychiatrist

Treatment as usual

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital Bipolar Clinic and Research Program

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Bipolar Disorder; Anxiety Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Results Point of Contact

• Title: Kristen Ellard, PhD
• Organization: Massachusetts General Hospital

kellard@partners.org

617-726-6422

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Bipolar Clinic and Research Program

Study Record Dates

• First Submitted: July 1, 2013
• First Posted: July 4, 2013
• Study Start: June 1, 2013
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: May 12, 2017
• Results First Posted: May 12, 2017

Record last verified: 2017-05

Locations

US (1)