Pulmonary Disease, Chronic ObstructiveNCT00601055
Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease
A study testing Problem Solving-Rx Adherence (PSA) and PID-C in people with Pulmonary Disease, Chronic Obstructive and Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Depression
- What is being tested?
- Problem Solving-Rx Adherence (PSA) and PID-C
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2008to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- Taking drugs known to cause depression (e.g., reserpine, alpha-methyl-dopa, steroids)
- Current involvement in psychotherapy
- Requires nursing home placement after discharge
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Burke Rehabilitation Hospital
White Plains, New York, 10605
Weill Medical College of Cornell University
White Plains, New York, 10605
About this study
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.
Read the 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 (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.
- Conditions
- Pulmonary Disease, Chronic Obstructive, Depression
- Being tested
- Problem Solving-Rx Adherence (PSA), PID-C
- Keywords
- COPD, Geriatric Depression, Problem-Solving Therapy, Treatment Adherence
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Depression, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Problem Solving-Rx Adherence (PSA)Behavioural
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.
PID-CBehavioural
In PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.
| Study group | Role | What they receive |
|---|---|---|
| Problem Solving-Rx Adherence (PSA) | Experimental | Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PSA). Receives: Behavioral: Problem Solving-Rx Adherence (PSA) |
| PID-C | Active comparator | Participants will receive adherence-enhanced (PID-C) procedures, a treatment mobilizing patients to participate in their care. Receives: Behavioral: PID-C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Measured: Measured at week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2008 (estimated)
- Study startFeb 2008
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- George S. Alexopoulos, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00601055
- Sponsor's protocol ID
- R01MH076829
- Other IDs
- 0511008253, R01MH076829
- Status last verified
- Jul 2016
- First submitted
- 14 Jan 2008
- Last updated
- 15 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 40960814
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Older Patients With Major Depression and Severe COPD
- ClinicalTrials.gov ID
- NCT00601055
- Acronym / sponsor ID
- R01MH076829
- Conditions
- Pulmonary Disease, Chronic Obstructive, Depression
- Keywords
- COPD, Geriatric Depression, Problem-Solving Therapy, Treatment Adherence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2008
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 (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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Problem Solving-Rx Adherence (PSA) | Experimental | Behavioral: Problem Solving-Rx Adherence (PSA)Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PSA). |
| PID-C | Active comparator | Behavioral: PID-CParticipants will receive adherence-enhanced (PID-C) procedures, a treatment mobilizing patients to participate in their care. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Problem Solving-Rx Adherence (PSA) |
| PID-CIn PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles. | Behavioural | PID-C |
Primary outcome
Depressive symptoms
Time frame: Measured at week 26
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2016.
- Derived from this study: PubMed 40960814Solomonov 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George S. Alexopoulos, MD principal investigator
Weill Medical College of Cornell University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Problem Solving-Rx Adherence (PSA) and PID-C in people with Pulmonary Disease, Chronic Obstructive and Depression, run by Weill Medical College of Cornell University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Measured at week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00601055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2016.