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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00601055
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : July 15, 2016
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Pulmonary Disease, Chronic Obstructive Depression Behavioral: Problem Solving-Rx Adherence (PSA) Behavioral: PID-C

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 (PSA) in treating older people with major depression and COPD.

Participants in this open label study will be randomly assigned to one of two groups: PSA or PID-C. In PSA, 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 PID-C, 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 26 after discharge from Burke. All assessments will focus on depression severity, level of general functioning, and COPD treatment adherence.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 101 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treating Older Patients With Major Depression and Severe COPD
Study Start Date : February 2008
Primary Completion Date : August 2015
Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Problem Solving-Rx Adherence (PSA)
Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PSA).
Behavioral: Problem Solving-Rx Adherence (PSA)
In PSA, 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.
Active Comparator: PID-C
Participants will receive adherence-enhanced (PID-C) procedures, a treatment mobilizing patients to participate in their care.
Behavioral: PID-C
In PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.

Outcome Measures

Primary Outcome Measures :
  1. Depressive symptoms [ Time Frame: Measured at week 26 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 95 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00601055

United States, New York
The Burke Rehabilitation Hospital
White Plains, New York, United States, 10605
Weill Medical College of Cornell University
White Plains, New York, United States, 10605
Sponsors and Collaborators
Weill Medical College of Cornell University
National Institute of Mental Health (NIMH)
Principal Investigator: George S. Alexopoulos, MD Weill Medical College of Cornell University
More Information

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00601055     History of Changes
Obsolete Identifiers: NCT00504569
Other Study ID Numbers: R01MH076829 ( U.S. NIH Grant/Contract )
0511008253 ( Other Identifier: Weill Cornell IRB Protocol Number )
First Posted: January 25, 2008    Key Record Dates
Last Update Posted: July 15, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

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