NCT01694628

Brief Summary

The purpose of this study in patients with advanced COPD and depression is twofold:

  1. 1.Determine the feasibility and acceptability of a 6-session e-counseling intervention
  2. 2.Determine the efficacy of the e-counseling intervention on depressive symptoms

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

September 1, 2012

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 24, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 27, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2016

Enrollment Period

2.2 years

First QC Date

September 24, 2012

Last Update Submit

September 27, 2021

Conditions

COPDDepression

Outcome Measures

Primary Outcomes (1)

  • Depressive Symptoms

    Personal Health Questionnaire-9

    8 weeks

Secondary Outcomes (5)

  • Dyspnea Intensity and Distress

    8 weeks

  • Fatigue

    8 weeks

  • Anxiety

    8 weeks

  • Physical Activity

    8 weeks

  • Quality of Life

    8 weeks

Study Arms (2)

CLIMB (COPD Lifestyle, Mood, and Behavior)

EXPERIMENTAL

Counseling sessions for COPD and depression

Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior)

Control

NO INTERVENTION

Usual Care

Interventions

CLIMB (COPD Lifestyle, Mood, and Behavior)BEHAVIORAL

Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.

CLIMB (COPD Lifestyle, Mood, and Behavior)

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • COPD (FEV1/FVC \< 70% \& FEV1 \<80%; current or past smoking \>10pack-years)
  • Depressed (PHQ-9 \>=10)
  • Ability to speak, read and write English
  • Willingness to use computer or study-issued tablet device

You may not qualify if:

  • Current non-nicotine substance abuse or dependence
  • Psychotic disorder
  • Active suicide ideation with intent and plan
  • Alzheimer's/dementia
  • Currently receiving any psychotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic ObstructiveDepression

Condition Hierarchy (Ancestors)

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

Study Officials

  • Lynn F Reinke, PhD, RN

    University of Washington

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Associate Professor

Study Record Dates

First Submitted

September 24, 2012

First Posted

September 27, 2012

Study Start

September 1, 2012

Primary Completion

December 1, 2014

Study Completion

October 1, 2016

Last Updated

October 5, 2021

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)