COPDCLIMBNCT01694628
Cognitive Behavioral Therapy for COPD
A study testing CLIMB (COPD Lifestyle, Mood, and Behavior) in people with COPD and Depression, run by University of Washington at 1 site in United States.
Trial summary
The purpose of this study in patients with advanced COPD and depression is twofold: 1. Determine the feasibility and acceptability of a 6-session e-counseling intervention 2. Determine the efficacy of the e-counseling intervention on depressive symptoms We hypothesize that patients who participate in e-counseling will… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD, Depression
- What is being tested?
- CLIMB (COPD Lifestyle, Mood, and Behavior)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Oct 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current non-nicotine substance abuse or dependence
- Psychotic disorder
- Active suicide ideation with intent and plan
- Alzheimer's/dementia
- Currently receiving any psychotherapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression
The purpose of this study in patients with advanced COPD and depression is twofold:
- Determine the feasibility and acceptability of a 6-session e-counseling intervention
- Determine the efficacy of the e-counseling intervention on depressive symptoms
We hypothesize that patients who participate in e-counseling will have improved depressive symptoms compared to patients receiving usual care at 8 weeks.
Read the detailed description
Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. Although COPD is mostly preventable, there is no cure. Thus, care of patients with COPD is primarily focused on symptom palliation with the goal of improving quality of life for both patients and their families. These goals are highly consistent with core principles of palliative care. Dyspnea is the most distressing symptom for patients. Even optimal disease-directed treatment provides only partial relief from dyspnea. Depression is consistently associated with worse dyspnea, but the mechanisms underlying this relationship are poorly understood. Since existing treatment for dyspnea has only limited success and there is evidence that treating depression alleviates pain, we propose that by improving mood, we may be more successful in alleviating dyspnea. Psychosocial-behavioral therapy (PBT) which is focused on increasing pleasant events and improving problem solving skills has been shown to have immediate and sustained effects on depressive symptoms in patients with dementia and post-stroke holds tremendous promise for efficacy in advanced COPD. Testing the use of novel technologies to provide efficacious interventions such as PBT to patients with advanced disease is critical for translational palliative care research
- Conditions
- COPD, Depression
- Being tested
- CLIMB (COPD Lifestyle, Mood, and Behavior)
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CLIMB (COPD Lifestyle, Mood, and Behavior)Behavioural
Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms.
| Study group | Role | What they receive |
|---|---|---|
| CLIMB (COPD Lifestyle, Mood, and Behavior) | Experimental | Counseling sessions for COPD and depression Receives: Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior) |
| Control | No intervention | Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive Symptoms
Personal Health Questionnaire-9
Measured: 8 weeks
Secondary outcomes (5)
Dyspnea Intensity and Distress
Chronic Respiratory Questionnaire, Shortness of Breath Questionnaire, Dyspnea Management Questionnaire
Measured: 8 weeks
Fatigue
Chronic Respiratory Questionnaire
Measured: 8 weeks
Anxiety
Hospital Anxiety and Depression Scale
Measured: 8 weeks
Physical Activity
Accelerometry (Stepwatch)
Measured: 8 weeks
Quality of Life
Chronic Respiratory Questionnaire and Medical Outcomes Short Form-36
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionDec 2014
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Responsible party
- Principal investigator, Lynn Foster Reinke, University of Washington
- Investigators
- Lynn F Reinke, PhD, RN, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694628
- Sponsor's protocol ID
- 43252
- Acronym
- CLIMB
- Status last verified
- Oct 2016
- First submitted
- 24 Sep 2012
- Last updated
- 5 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial-Behavioral Therapy for Patients With Advanced COPD and Depression
- ClinicalTrials.gov ID
- NCT01694628
- Acronym / sponsor ID
- CLIMB / 43252
- Conditions
- COPD, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Icahn School of Medicine at Mount Sinai
- Study start
- Sep 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 27 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study in patients with advanced COPD and depression is twofold:
- Determine the feasibility and acceptability of a 6-session e-counseling intervention
- Determine the efficacy of the e-counseling intervention on depressive symptoms
We hypothesize that patients who participate in e-counseling will have improved depressive symptoms compared to patients receiving usual care at 8 weeks.
Detailed description
Chronic obstructive pulmonary disease (COPD) is the third leading cause of the death in the US. Although COPD is mostly preventable, there is no cure. Thus, care of patients with COPD is primarily focused on symptom palliation with the goal of improving quality of life for both patients and their families. These goals are highly consistent with core principles of palliative care. Dyspnea is the most distressing symptom for patients. Even optimal disease-directed treatment provides only partial relief from dyspnea. Depression is consistently associated with worse dyspnea, but the mechanisms underlying this relationship are poorly understood. Since existing treatment for dyspnea has only limited success and there is evidence that treating depression alleviates pain, we propose that by improving mood, we may be more successful in alleviating dyspnea. Psychosocial-behavioral therapy (PBT) which is focused on increasing pleasant events and improving problem solving skills has been shown to have immediate and sustained effects on depressive symptoms in patients with dementia and post-stroke holds tremendous promise for efficacy in advanced COPD. Testing the use of novel technologies to provide efficacious interventions such as PBT to patients with advanced disease is critical for translational palliative care research
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CLIMB (COPD Lifestyle, Mood, and Behavior) | Experimental | Behavioral: CLIMB (COPD Lifestyle, Mood, and Behavior)Counseling sessions for COPD and depression |
| Control | No intervention | –Usual Care |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Current non-nicotine substance abuse or dependence
- Psychotic disorder
- Active suicide ideation with intent and plan
- Alzheimer's/dementia
- Currently receiving any psychotherapy
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 |
|---|---|---|
| CLIMB (COPD Lifestyle, Mood, and Behavior)Cognitive Behavioral Therapy delivered to patients via telephone aimed to improve mood and decrease depressive symptoms. | Behavioural | CLIMB (COPD Lifestyle, Mood, and Behavior) |
Primary outcome
Depressive Symptoms
Time frame: 8 weeks
Personal Health Questionnaire-9
5 secondary outcomes
Dyspnea Intensity and Distress
Time frame: 8 weeks
Fatigue
Time frame: 8 weeks
Anxiety
Time frame: 8 weeks
Physical Activity
Time frame: 8 weeks
Quality of Life
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Lynn F Reinke, PhD, RN principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CLIMB (COPD Lifestyle, Mood, and Behavior) in people with COPD and Depression, run by University of Washington at 1 site 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 5 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 5 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Depressive Symptoms (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Oct 2021; AzTrials last refreshed its copy on 3 Nov 2026.