Treatment for Chronic Depression

NCT00204152 | Terminated Phase 3

• 1 other identifier: 13166B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Major Depressive Disorder

Keywords

Early onset depression; early adversity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cognitive functioning, social/behavioral functioning, and stress regulation.

Interventions

(Condition 1) Behavioral Activation; (Condition 2) Behavioral Activation and Stress Innoculation BEHAVIORAL

Eligibility Criteria

• Age: 18 Years - 58 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago, Department of Psychiatry

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Jacobson NS, Dobson KS, Truax PA, Addis ME, Koerner K, Gollan JK, Gortner E, Prince SE. A component analysis of cognitive-behavioral treatment for depression. J Consult Clin Psychol. 1996 Apr;64(2):295-304. doi: 10.1037//0022-006x.64.2.295.

  PMID: 8871414 BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Jackie K Gollan, Ph.D.

  The University of Chicago, Department of Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 20, 2005
• Study Start: June 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: September 5, 2013

Record last verified: 2013-09

Locations

US (1)