NCT00601055

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
101

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 14, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 25, 2008

Completed
7 days until next milestone

Study Start

First participant enrolled

February 1, 2008

Completed
7.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
Last Updated

July 15, 2016

Status Verified

July 1, 2016

Enrollment Period

7.5 years

First QC Date

January 14, 2008

Last Update Submit

July 13, 2016

Conditions

Pulmonary Disease, Chronic ObstructiveDepression

Keywords

COPDGeriatric DepressionProblem-Solving TherapyTreatment Adherence

Outcome Measures

Primary Outcomes (1)

  • Depressive symptoms

    Measured at week 26

Study Arms (2)

Problem Solving-Rx Adherence (PSA)

EXPERIMENTAL

Participants will receive problem-solving therapy integrated with adherence-enhanced procedures (PSA).

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.

Behavioral: PID-C

Interventions

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.

Problem Solving-Rx Adherence (PSA)
PID-CBEHAVIORAL

In PID-C, a therapist identifies obstacles to treatment adherence and helps the participant overcome those obstacles.

PID-C

Eligibility Criteria

Age50 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Burke Rehabilitation Hospital

White Plains, New York, 10605, United States

Location

Weill Medical College of Cornell University

White Plains, New York, 10605, United States

Location

Related Publications (1)

  • 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.

    PMID: 40960814DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDepressionTreatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorHealth Behavior

Study Officials

  • George S. Alexopoulos, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 14, 2008

First Posted

January 25, 2008

Study Start

February 1, 2008

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

July 15, 2016

Record last verified: 2016-07

Locations

US(2)