Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease
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Purpose
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 Depression |
Behavioral: Problem-solving therapy (PST) Behavioral: Adherence-enhanced procedures (AE) |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Treating Older Patients With Major Depression and Severe COPD |
- Depressive symptoms [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
- Adherence to treatments for COPD [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PST-AE)
|
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.
|
|
Active Comparator: 2
Participants will receive adherence-enhanced procedures
|
Behavioral: Adherence-enhanced procedures (AE)
In AE, 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 (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.
Eligibility| Ages Eligible for Study: | 50 Years to 95 Years |
| Genders Eligible for Study: | Both |
| 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| 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 |
More Information
No publications provided
| Responsible Party: | George S. Alexopoulos, MD, Weill Medical College of Cornell University |
| ClinicalTrials.gov Identifier: | NCT00601055 History of Changes |
| Obsolete Identifiers: | NCT00504569 |
| Other Study ID Numbers: | R01 MH076829, 0511008253, DATR A4-GPS |
| Study First Received: | January 14, 2008 |
| Last Updated: | August 9, 2011 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institute of Mental Health (NIMH):
|
COPD Depression Problem-Solving Therapy Treatment Adherence |
Additional relevant MeSH terms:
|
Chronic Disease Depression Depressive Disorder Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Depressive Disorder, Major |
Lung Diseases, Obstructive Disease Attributes Pathologic Processes Behavioral Symptoms Mood Disorders Mental Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on May 22, 2013