Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease

This study is currently recruiting participants.
Verified December 2013 by Weill Medical College of Cornell University
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University
ClinicalTrials.gov Identifier:
NCT00601055
First received: January 14, 2008
Last updated: December 19, 2013
Last verified: December 2013

January 14, 2008
December 19, 2013
February 2008
February 2014   (final data collection date for primary outcome measure)
  • Depressive symptoms [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
  • Adherence to treatments for COPD [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00601055 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease
Treating Older Patients With Major Depression and Severe COPD

This study will evaluate the effectiveness of problem-solving therapy combined with treatment adherence procedures in treating older people with major depression and chronic obstructive pulmonary disease.

Depression is a serious illness that affects a person's mood, thoughts, and physical well-being. Common symptoms of depression include persistent feelings of anxiety, guilt, or hopelessness; irregular sleep and appetite patterns; lethargy; disinterest in previously enjoyed activities; excessive irritability and restlessness; suicidal thoughts; and inability to concentrate. Depression often occurs in the presence of one or more other disorders. For example, depression is reported to be at a higher rate in people with chronic obstructive pulmonary disease (COPD) than in the general population. COPD is a disease in which the lungs are damaged, making it difficult to breathe. Symptoms most commonly include chronic coughing and shortness of breath. A primary cause of COPD is cigarette smoking. Following a prescribed treatment plan is important for managing COPD. Unfortunately, people with COPD often do not adhere to their treatment plans. Being depressed makes adherence even more difficult. This study will evaluate the effectiveness of problem-solving therapy integrated with adherence-enhanced procedures (PST-AE) in treating older people with major depression and COPD.

Participants in this open label study will be randomly assigned to one of two groups: PST-AE or AE. In PST-AE, a therapist will teach participants problem-solving strategies focusing on treatment adherence, depressive symptoms, and disability. Participants will learn behaviors and solutions to help cope with these problems. In AE, a therapist will teach participants to identify obstacles to treatment adherence and to discover ways to overcome them. The treatment sessions for both groups will be initiated at the inpatient Pulmonary Unit of Burke Rehabilitation Hospital and will continue in the participants' homes. All participants will receive two treatment sessions during hospitalization, eight weekly sessions following discharge, and four monthly sessions after that. While hospitalized at Burke, participants will also undergo an assessment interview for 1.5 hours and another interview for 20 minutes 2 weeks following the initial assessment. Interviews lasting 1.5 hours will also occur in the homes of the participants at Weeks 10, 14, and 24 after discharge from Burke. All assessments will focus on depression severity, level of general functioning, and COPD treatment adherence.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pulmonary Disease, Chronic Obstructive
  • Depression
  • Behavioral: Problem-solving therapy (PST)
    In PST, a therapist teaches the participant to identify problems related to depression, functioning, and treatment adherence; to generate multiple solutions; and to choose and implement one or more of those solutions.
  • Behavioral: Adherence-enhanced procedures (AE)
    In AE, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.
  • Experimental: 1
    Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PST-AE)
    Interventions:
    • Behavioral: Problem-solving therapy (PST)
    • Behavioral: Adherence-enhanced procedures (AE)
  • Active Comparator: 2
    Participants will receive adherence-enhanced procedures
    Intervention: Behavioral: Adherence-enhanced procedures (AE)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
February 2014
February 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Meets American Thoracic Society criteria for COPD
  • Meets DSM-IV criteria for unipolar major depression
  • Scores greater than 19 on 24-item Hamilton Depression Rating Scale
  • Fluency in English sufficient for comprehending the questionnaires of the study and for understanding the therapists

Exclusion Criteria:

  • Unable to give informed consent
  • Experiencing suicidal thoughts
  • History of or currently meets DSM-IV criteria for the following Axis I disorders: psychotic depression, psychotic disorder, bipolar disorder, dysthymic disorder, obsessive compulsive disorder, or current substance abuse
  • Meets DSM-IV criteria for Axis II diagnosis of antisocial personality (by SCID-P and DSM-IV)
  • Scores less than 24 on Mini-Mental State Exam (MMSE) or meets DSM-IV criteria for dementia
  • Certain illnesses (e.g., untreated thyroid or adrenal disease, pancreatic cancer, lymphoma)
  • Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
  • Current involvement in psychotherapy
  • Requires nursing home placement after discharge
Both
50 Years to 95 Years
No
Contact: Timothy E. Clark, MTS 914-997-4390 tec2004@med.cornell.edu
United States
 
NCT00601055
R01 MH076829, 0511008253, DATR A4-GPS
Yes
Weill Medical College of Cornell University
Weill Medical College of Cornell University
Not Provided
Principal Investigator: George S. Alexopoulos, MD Weill Medical College of Cornell University
Weill Medical College of Cornell University
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP