Depression Clinical Trial
Official title:
Treating Older Patients With Major Depression and Severe COPD
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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