Treatment of Depressed Chronic Obstructive Pulmonary Disease Patients

NCT ID: NCT00151372

Last Updated: 2010-01-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

141 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-03-31

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pulmonary Disease, Chronic Obstructive Major Depression

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment Adherence Intervention

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.

Group Type EXPERIMENTAL

Treatment Adherence Intervention

Intervention Type BEHAVIORAL

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 Care

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.

Group Type ACTIVE_COMPARATOR

Enhanced Care

Intervention Type BEHAVIORAL

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.

Interventions

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Treatment Adherence Intervention

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.

Intervention Type BEHAVIORAL

Enhanced Care

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Chronic obstructive pulmonary disease by American Thoracic Society criteria
* Major depression by DSM-IV criteria
* 17-item Hamilton score \>14
* English speaking

Exclusion Criteria

* Inability to give informed consent
* MiniMental score \<24
* Aphasia
* Nursing home placement after discharge
Minimum Eligible Age

50 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role collaborator

Weill Medical College of Cornell University

OTHER

Sponsor Role lead

Responsible Party

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Weill Medical College of Cornell University

Principal Investigators

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George S Alexopoulos, MD

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Locations

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Helen Hayes Hospital

West Haverstraw, New York, United States

Site Status

Burke Rehabilitation Hospital

White Plains, New York, United States

Site Status

Weill Medical College of Cornell University

White Plains, New York, United States

Site Status

Countries

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United States

References

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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 Sep 17:e252518. doi: 10.1001/jamapsychiatry.2025.2518. Online ahead of print.

Reference Type DERIVED
PMID: 40960814 (View on PubMed)

Other Identifiers

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R01HL071992-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

0201005319

Identifier Type: -

Identifier Source: org_study_id

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