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Sponsored by: |
National Institute of Mental Health (NIMH) |
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Information provided by: | National Institute of Mental Health (NIMH) |
ClinicalTrials.gov Identifier: | NCT00601055 |
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 |
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Pulmonary Disease, Chronic Obstructive Depression |
Behavioral: Problem-solving therapy (PST) Behavioral: Adherence-enhanced procedures (AE) |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Treating Older Patients With Major Depression and Severe COPD |
Estimated Enrollment: | 160 |
Study Start Date: | February 2008 |
Estimated Study Completion Date: | February 2013 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PST-AE)
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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.
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2: Active Comparator
Participants will receive adherence-enhanced procedures
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Behavioral: Adherence-enhanced procedures (AE)
In AE, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.
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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.
Ages Eligible for Study: | 50 Years to 95 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Timothy E. Clark, MTS | 914-997-4390 | tec2004@med.cornell.edu |
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 |
Principal Investigator: | George S. Alexopoulos, MD | Weill Medical College of Cornell University |
Responsible Party: | Weill Medical College of Cornell University ( George S. Alexopoulos, MD ) |
Study ID Numbers: | R01 MH076829, 0511008253, DATR A4-GPS |
Study First Received: | January 14, 2008 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00601055 |
Health Authority: | United States: Federal Government |
COPD Depression Problem-Solving Therapy Treatment Adherence |
Lung Diseases, Obstructive Depression Respiratory Tract Diseases Mental Disorders Lung Diseases Respiration Disorders |
Mood Disorders Chronic Disease Depressive Disorder, Major Depressive Disorder Behavioral Symptoms Pulmonary Disease, Chronic Obstructive |
Disease Attributes Pathologic Processes |