Problem-Solving Therapy for People With Major Depression and Chronic Obstructive Pulmonary Disease

Depression Clinical Trial

Official title:

Treating Older Patients With Major Depression and Severe COPD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00601055
• Other study ID #: R01MH076829
• Secondary ID: 0511008253R01MH0
• Status: Completed
• Phase: N/A
• First received: January 14, 2008
• Last updated: July 13, 2016
• Start date: February 2008
• Est. completion date: August 2015

Study information

• Verified date: July 2016
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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.

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.

Other known NCT identifiers

• NCT00504569

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 95 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Disease
• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
United States	The Burke Rehabilitation Hospital	White Plains	New York
United States	Weill Medical College of Cornell University	White Plains	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depressive symptoms		Measured at week 26	No