Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease
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|ClinicalTrials.gov Identifier: NCT00601055|
Recruitment Status : Completed
First Posted : January 25, 2008
Last Update Posted : July 15, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pulmonary Disease, Chronic Obstructive Depression||Behavioral: Problem Solving-Rx Adherence (PSA) Behavioral: PID-C||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||101 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treating Older Patients With Major Depression and Severe COPD|
|Study Start Date :||February 2008|
|Actual Primary Completion Date :||August 2015|
|Actual Study Completion Date :||August 2015|
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.
In PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.
- Depressive symptoms [ Time Frame: Measured at week 26 ]
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|
|Principal Investigator:||George S. Alexopoulos, MD||Weill Medical College of Cornell University|