Pulmonary Disease, Chronic ObstructiveNCT00151372
Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients
A study testing Treatment Adherence Intervention and Enhanced Care in people with Pulmonary Disease, Chronic Obstructive and Major Depression, run by Weill Medical College of Cornell University at 3 sites in United States.
Trial summary
Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major depression, a condition that contributes to suffering but also to poor treatment adherence leading to increased disability and morbidity. Read more about this study
- Who is it for?
- Ages 50 to 95 years
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive, Major Depression
- What is being tested?
- Treatment Adherence Intervention and Enhanced Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 3 sitesUnited States
- Study dates
- Mar 2002to Jul 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Chronic obstructive pulmonary disease by American Thoracic Society criteria
- Major depression by DSM-IV criteria
- 17-item Hamilton score >14
- English speaking
Who cannot join
- Inability to give informed consent
- MiniMental score <24
- Aphasia
- Nursing home placement after discharge
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Helen Hayes Hospital
West Haverstraw, New York, 10993
Burke Rehabilitation Hospital
White Plains, New York, 10605
Weill Medical College of Cornell University
White Plains, New York, 10605
About this study
Official title: Treatment Effectiveness in Depressed Patients With Chronic Obstructive Pulmonary Disease
Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major depression, a condition that contributes to suffering but also to poor treatment adherence leading to increased disability and morbidity. This study investigates the effectiveness of a care management intervention aimed at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week follow-up period.
- Being tested
- Treatment Adherence Intervention, Enhanced Care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment Adherence InterventionBehavioural
The care management intervention aims at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability.
Enhanced CareBehavioural
For subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the Agency for Health Care Policy and Research (AHCPR) guidelines for the treatment of depression in primary care with an addendum updating the tables describing Selective Serotonin Reuptake Inhibitors (SSRI) side effect and dosage profiles. The investigators expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in chronic obstructive pulmonary disease patients.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Adherence Intervention | Experimental | In the Treatment Adherence Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease treatment adherence and to help the participant overcome those obstacles. Receives: Behavioral: Treatment Adherence Intervention |
| Enhanced Care | Active comparator | In the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team. Receives: Behavioral: Enhanced Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Antidepressant Score Scale (CAD)
The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.
Measured: 28 Weeks
Secondary outcomes (1)
Hamilton Depression Rating Scale
The 17-item Hamilton Depression Rating Scale (HDRS) measures the severity of a depressive episode: the higher the score, the more severe the depression. The Best value is 0 and the Worst value is 52.
Measured: 28 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2005 (estimated)
- Study startMar 2002
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Investigators
- George S Alexopoulos, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00151372
- Sponsor's protocol ID
- 0201005319
- Other IDs
- R01HL071992-05
- Status last verified
- Dec 2009
- First submitted
- 6 Sep 2005
- Last updated
- 11 Jan 2010
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
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 11 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Effectiveness in Depressed Patients With Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT00151372
- Acronym / sponsor ID
- 0201005319
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Mar 2002
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 8 Sep 2005 (estimated)
- Results
- Posted 11 Jan 2010
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Approximately 20% of patients with chronic obstructive pulmonary disease (COPD) have major depression, a condition that contributes to suffering but also to poor treatment adherence leading to increased disability and morbidity. This study investigates the effectiveness of a care management intervention aimed at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability at a 28-week follow-up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment Adherence Intervention | Experimental | Behavioral: Treatment Adherence InterventionIn the Treatment Adherence Intervention group, a study therapist regularly meets with subjects in order to identify obstacles to depression and chronic obstructive pulmonary disease treatment adherence and to help the participant overcome those obstacles. |
| Enhanced Care | Active comparator | Behavioral: Enhanced CareIn the Enhanced Care group, physicians providing aftercare will be informed in writing of the patients' diagnosis but will receive no clinical instructions by the research team. |
Who may qualify
- Ages
- 50 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Chronic obstructive pulmonary disease by American Thoracic Society criteria
- Major depression by DSM-IV criteria
- 17-item Hamilton score >14
- English speaking
Key exclusion criteria (4 listed)
- Inability to give informed consent
- MiniMental score <24
- Aphasia
- Nursing home placement after discharge
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 |
|---|---|---|
| Treatment Adherence InterventionThe care management intervention aims at facilitating adherence to a treatment algorithm based on the Agency for Health Care Policy and Research (AHCPR) guidelines. The investigators hypothesize that this intervention, in comparison to usual care, will increase the prescription of adequate antidepressant treatment by physicians, enhance treatment adherence by patients, and reduce depressive symptoms, suicide ideation, and disability. | Behavioural | Treatment Adherence Intervention |
| Enhanced CareFor subjects in the Enhanced Care group, physicians providing aftercare will receive no clinical instructions by the research team, but will be informed in writing of the patients' diagnosis and will be provided with a copy of the Agency for Health Care Policy and Research (AHCPR) guidelines for the treatment of depression in primary care with an addendum updating the tables describing Selective Serotonin Reuptake Inhibitors (SSRI) side effect and dosage profiles. The investigators expect that these physicians will continue to base their practice on clinical judgment about how best to treat depression in chronic obstructive pulmonary disease patients. | Behavioural | Enhanced Care |
Primary outcome
Composite Antidepressant Score Scale (CAD)
Time frame: 28 Weeks
The Composite Antidepressant Score scale (CAD) describes the adequacy of an antidepressant's dosage. Scores range from 0-4 with 0, 1, and 2 signifying subthreshold or non-adequate therapeutic dosages while 3 and 4 signify a therapeutic/adequate dosage. The best value is 4 while the worst value is 0.
1 secondary outcome
Hamilton Depression Rating Scale
Time frame: 28 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2010.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment Adherence Intervention and Enhanced Care in people with Pulmonary Disease, Chronic Obstructive and Major Depression, run by Weill Medical College of Cornell University at 3 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 4 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 11 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Yes. Results are posted in the registry (first posted 11 Jan 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Composite Antidepressant Score Scale (CAD) (time frame: 28 Weeks). 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 NCT00151372, 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 11 Jan 2010.