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

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition Intervention
Pulmonary Disease, Chronic Obstructive
Depression
Behavioral: Problem-solving therapy (PST)
Behavioral: Adherence-enhanced procedures (AE)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treating Older Patients With Major Depression and Severe COPD

Resource links provided by NLM:


Further study details as provided by Weill Medical College of Cornell University:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 160
Study Start Date: February 2008
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PST-AE)
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.
Active Comparator: 2
Participants will receive adherence-enhanced procedures
Behavioral: Adherence-enhanced procedures (AE)
In AE, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00601055

Contacts
Contact: Timothy E. Clark, MTS 914-997-4390 tec2004@med.cornell.edu

Locations
United States, New York
Weill Medical College of Cornell University Recruiting
White Plains, New York, United States, 10605
Principal Investigator: George S. Alexopoulos, MD         
The Burke Rehabilitation Hospital Recruiting
White Plains, New York, United States, 10605
Principal Investigator: Richard S. Novitch, MD         
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: George S. Alexopoulos, MD Weill Medical College of Cornell University
  More Information

No publications provided

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00601055     History of Changes
Obsolete Identifiers: NCT00504569
Other Study ID Numbers: R01 MH076829, 0511008253, DATR A4-GPS
Study First Received: January 14, 2008
Last Updated: December 19, 2013
Health Authority: United States: Federal Government

Keywords provided by Weill Medical College of Cornell University:
COPD
Depression
Problem-Solving Therapy
Treatment Adherence

Additional relevant MeSH terms:
Depression
Depressive Disorder
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Depressive Disorder, Major
Chronic Disease
Behavioral Symptoms
Mood Disorders
Mental Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 29, 2014