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

This study has been completed.
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Weill Medical College of Cornell University Identifier:
First received: January 14, 2008
Last updated: July 13, 2016
Last verified: July 2016
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
Behavioral: Problem Solving-Rx Adherence (PSA)
Behavioral: PID-C

Study Type: Interventional
Study Design: Allocation: Randomized
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 week 26 ]

Enrollment: 101
Study Start Date: February 2008
Study Completion Date: August 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.


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
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 identifier: 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 Identifier: NCT00601055     History of Changes
Obsolete Identifiers: NCT00504569
Other Study ID Numbers: R01MH076829 ( US NIH Grant/Contract Award Number )
0511008253 ( Other Identifier: Weill Cornell IRB Protocol Number )
Study First Received: January 14, 2008
Last Updated: July 13, 2016
Individual Participant Data  
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 processed this record on May 23, 2017