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Treatment for Chronic Depression

This study has been terminated.
(PI left U of C)
Sponsor:
Information provided by (Responsible Party):
University of Chicago
ClinicalTrials.gov Identifier:
NCT00204152
First received: September 13, 2005
Last updated: September 4, 2013
Last verified: September 2013
  Purpose

The purpose of this study is to test the clinical efficacy of two psychotherapies for early onset chronic major depression, including Behavioral Activation (Jacobson et al., 2001), and an integrated version of Behavioral Activation and Stress Innoculation Coping (BASIC) for short-term (16 weeks) of individual psychotherapy for adults with chronic major depression. The control condition is an individual workbook condition of Behavioral Activation. These psychotherapies focus on behavior activation, stress reduction and coping strategies to counter depressive symptoms.


Condition Intervention Phase
Major Depressive Disorder
Behavioral: (Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Treatment for Chronic Depression With Behavioral Interventions

Further study details as provided by University of Chicago:

Primary Outcome Measures:
  • severity of depression, measured by Longitudinal Interval Follow-up Evaluation (LIFE; Keller et al., 1982; Keller et al., 1987), Beck Depression Inventory-II (BDI-II; Beck, Steer, & Brown, 1996a), and Hamilton Rating Scale for Depression.

Secondary Outcome Measures:
  • Cognitive functioning, social/behavioral functioning, and stress regulation.

Estimated Enrollment: 30
Study Start Date: June 2004
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Early-onset unipolar major depression is linked with considerable morbidity and mortality (Birmaher et al., 1996). The goal of this project is to test the efficacy of Behavioral Activation (BA; Jacobson et al., 2001) and an integrated version of Behavioral Activation (BA + Stress Inoculation Coping; BASIC) for the short-term psychotherapy of adults with chronic major depression (onset before age 18) and a history of early life stress before age 18. Exposure to stress during the developmental years has been linked with early-onset depression (Rao et al., 1996), a propensity to generate stress during the life span (Hammen et al., 1998), and a greater psychological sensitivity to stress as an adult (Post et al., 1992). And while incidence of early life stress is high among depressed adults, there are no behavioral treatments designed to address the unique needs of these individuals. We aim to develop a new treatment for a specific group of depressed patients, namely individuals who report early onset of depression and early life stress. We include the critical elements of behavioral activation and stress reduction strategies to address the avoidance, stress sensitivities, and coping deficits often observed in this population.

The specific aims are: 1) to determine if the addition of stress reduction strategies (packaged in BASIC) enhance the effects of BA, as indexed by the rate early remission; 2) to investigate if exposure to BA and BASIC reduce risk of relapse within three months of treatment termination, as indexed by reduced rates of relapse by the 3-month follow-up; and, 3) to learn if effects of BA are mediated by changes in activity behaviors or the acquisition of compensatory behavioral skills, and likewise whether enduring effects of BASIC are mediated by changes in stress regulation or the acquisition of stress regulation skills. Our approach is to compare BA and BASIC to a self-guided bibliotherapy of BA (control condition) using a randomized clinical trial design to distinguish between conditions. We anticipate that this study will promote our understanding about the efficacy of BA and the discovery of mechanisms of treatment response. We expect this project to facilitate our understanding of the mechanisms that promote treatment gains and contribute to depressive relapse.

  Eligibility

Ages Eligible for Study:   18 Years to 58 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • depressed male and female subjects between ages 18 to 58 years.
  • current and primary diagnosis of DSM-IV Major Depressive Disorder (e.g., no lifetime history of bipolar I or II disorder, current anxiety disorders, or current substance dependence disorder (American Psychiatric Association, 1994).
  • should also have upon study entry a score of 14 or higher (moderate depression) on the Hamilton Rating Scale for Depression (HRSD; Hamilton, 1960) and a score of 20 or higher (moderate depression) on the Beck Depression Inventory II (BDI-II; Beck et al., 1996a).
  • background of high childhood trauma (70-item Childhood Trauma Questionnaire with a Total Score of 9 or higher).
  • reasonably fluent in English to complete the evaluation.

Exclusion Criteria:

  • history of bipolar affective disorder,
  • history of psychosis (including schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic organic brain syndrome)
  • current non-psychotic Axis I disorder if it constitutes the predominant aspect of the clinical presentation and if it requires treatment other than that offered in the project (including anxiety disorders, somatoform disorders, dissociative disorders, or eating disorders, etc.),
  • history of substance dependence in the past six months,
  • antisocial, borderline, or schizotypal personality disorder,
  • evidence of any medical disorder or condition that could cause depression or preclude the use of study treatments,
  • current treatment with catecholaminergic antihypertensive medication, including reserpine, beta-blockers, clonidine, alphamethyldopa, etc. (diuretics, ACE inhibitors and calcium channel inhibitors will be allowed),
  • clear indication of secondary gain (e.g., court ordered treatment or compensation issues),
  • current suicide risk sufficient to preclude treatment on an outpatient basis (any patient scoring 3 or above on the suicide item on the HRSD or BDI must be cleared for study participation by the PI).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00204152

Locations
United States, Illinois
The University of Chicago, Department of Psychiatry
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Jackie K Gollan, Ph.D. The University of Chicago, Department of Psychiatry
  More Information

Publications:
Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT00204152     History of Changes
Other Study ID Numbers: 13166B
Study First Received: September 13, 2005
Last Updated: September 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Chicago:
Early onset depression
early adversity

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mental Disorders
Mood Disorders

ClinicalTrials.gov processed this record on November 27, 2014