| ID | Type | Description | Link |
|---|---|---|---|
| 0511008253 | Other Identifier | Weill Cornell IRB Protocol Number | |
| R01MH076829 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Problem Solving-Rx Adherence (PSA) | Experimental | Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PSA). |
|
| PID-C | Active Comparator | Participants will receive adherence-enhanced (PID-C) procedures, a treatment mobilizing patients to participate in their care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Problem Solving-Rx Adherence (PSA) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive symptoms | Measured at week 26 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| George S. Alexopoulos, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Burke Rehabilitation Hospital | White Plains | New York | 10605 | United States | ||
| Weill Medical College of Cornell University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40960814 | Derived | Solomonov N, Kerchner D, Bein O, Lee CE, Diaz JL, Ciarleglio A, Kim S, Sirey JA, Gunning FM, Raue PJ, Banerjee S, Arean PA, Alexopoulos GS. Precision Assignment to Psychosocial Interventions for Late-Life Depression: An Automated Treatment Decision Rule. JAMA Psychiatry. 2025 Nov 1;82(11):1075-1084. doi: 10.1001/jamapsychiatry.2025.2518. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D003863 | Depression |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| PID-C | Behavioral | In PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles. |
|
| White Plains |
| New York |
| 10605 |
| United States |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D015438 | Health Behavior |