AnxietyPhase 2NCT00545922
Cognitive Behavioral Therapy for Anxiety and Depression in COPD
A Phase 2 study testing Cognitive behavioral therapy and Minimal Telephone Contact in people with Anxiety and Depression, run by University of Bergen at 1 site in Norway.
Trial summary
The purpose of this study was to examine the efficacy of manualized, short-term group cognitive behavioral therapy for COPD patients suffering from clinically significant symptoms of anxiety and/or depression. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Anxiety, Depression, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Cognitive behavioral therapy and Minimal Telephone Contact
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteNorway
- Study dates
- Apr 2005to Nov 2007
- Phase
- Phase 2
- 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
- 40 years or older
- scores of 16 or higher on the Beck Anxiety Inventory and/or 14 or higher on the Beck Depression Inventory II
- COPD diagnosis
Who cannot join
- participation in other studies likely to influence the patient in terms of confounding effects
- signs of cognitive impairment defined by a score of less than 23 on the Mini-Mental State Examination
- presence of psychotic disorders, non-nicotine substance use disorders, bipolar disorders, or suicidal intentions as identified by clinical assessment based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-I/P)
- having a serious somatic condition preventing active participation in the present study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Behavior Therapy for Anxiety and Depression for Patients With Chronic Obstructive Pulmonary Disease (COPD): A Randomized, Controlled Clinical Trial in an Outpatient Pulmonary Clinic.
The purpose of this study was to examine the efficacy of manualized, short-term group cognitive behavioral therapy for COPD patients suffering from clinically significant symptoms of anxiety and/or depression.
Read the detailed description
Anxiety and depressive disorders have been demonstrated in 16-50% of patients with chronic obstructive pulmonary disease (COPD), and clinically significant levels of anxiety or depressive symptoms seem to be even more common.Despite the multiple, severe consequences, majority of COPD patients with co-morbid anxiety or depression do not seem to receive any treatment for the psychological disturbance.
Cognitive behavioral therapy (CBT) is a well-known approach for treating anxiety and depression, and data has demonstrated effectiveness of CBT for older individuals with anxiety. CBT has also improved exercise tolerance compliance in COPD patients, and pilot studies using CBT components have shown effectiveness in improving mental health and functional status for patients with COPD.
Given the increasing number of patients suffering from COPD and the high prevalence of anxiety and depression in the population, the current study was designed to examine the efficacy of CBT in groups for anxiety and depression in patients with COPD. At present, CBT-based interventions focusing on mental health symptoms are not widely available for COPD patients, and the potential of CBT for improving emotional well-being is not systematically considered in existing treatment alternatives. The study expands the findings from previous pilot studies by focusing on COPD patients with clinically significant levels of anxiety and depression. The wide breadth of coping skills included in the CBT intervention target symptoms of both anxiety and depression, and thus the utility of the intervention for managing mental health symptoms is not restricted to any specific DSM-IV diagnosis.
- Conditions
- Anxiety, Depression, Chronic Obstructive Pulmonary Disease
- Being tested
- Cognitive behavioral therapy, Minimal Telephone Contact
- Keywords
- chronic obstructive pulmonary disease, anxiety, depression, cognitive behavioral therapy
- Medical subject headings
- Anxiety Disorders, Depression, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapyBehavioural
Seven weekly sessions (2 hrs) in groups
Minimal Telephone ContactBehavioural
Telephone contact (max. 10 minutes) every other week during the 7-week intervention
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | 7 weekly sessions of group cognitive behavioral therapy Receives: Behavioral: Cognitive behavioral therapy |
| B | Active comparator | Minimal Telephone Contact Receives: Behavioral: Minimal Telephone Contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beck Anxiety Inventory
Measured: Intervention period of 8 weeks, 6 month follow-up
Beck Depression Inventory-II
Measured: Intervention period of 8 weeks, 6 month follow-up
Secondary outcomes (3)
St. George's Respiratory Questionnaire
Measured: Intervention period of 8 weeks, 6 month follow-up
Pittsburgh Sleep Quality Inventory
Measured: Intervention period of 8 weeks, 6 month follow-up
Actigraphy (Sleep effectiveness)
Measured: Intervention period of 8 weeks, 6 month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startApr 2005
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Bergen
- Sponsor type
- University, hospital or other
- Investigators
- Inger Hilde Nordhus, Dr. philos, Study director, University of Bergen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545922
- Sponsor's protocol ID
- REK 3.2007.1668
- Status last verified
- Oct 2007
- First submitted
- 16 Oct 2007
- Last updated
- 16 Nov 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavior Therapy for Anxiety and Depression for Patients With Chronic Obstructive Pulmonary Disease (COPD): A Randomized, Controlled Clinical Trial in an Outpatient Pulmonary Clinic.
- ClinicalTrials.gov ID
- NCT00545922
- Acronym / sponsor ID
- REK 3.2007.1668
- Conditions
- Anxiety, Depression, Chronic Obstructive Pulmonary Disease
- Keywords
- chronic obstructive pulmonary disease, anxiety, depression, cognitive behavioral therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- University of BergenUniversity, hospital or other
- Study start
- Apr 2005
- Study completion
- Nov 2007 (actual)
- First posted
- 17 Oct 2007 (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 was to examine the efficacy of manualized, short-term group cognitive behavioral therapy for COPD patients suffering from clinically significant symptoms of anxiety and/or depression.
Detailed description
Anxiety and depressive disorders have been demonstrated in 16-50% of patients with chronic obstructive pulmonary disease (COPD), and clinically significant levels of anxiety or depressive symptoms seem to be even more common.Despite the multiple, severe consequences, majority of COPD patients with co-morbid anxiety or depression do not seem to receive any treatment for the psychological disturbance.
Cognitive behavioral therapy (CBT) is a well-known approach for treating anxiety and depression, and data has demonstrated effectiveness of CBT for older individuals with anxiety. CBT has also improved exercise tolerance compliance in COPD patients, and pilot studies using CBT components have shown effectiveness in improving mental health and functional status for patients with COPD.
Given the increasing number of patients suffering from COPD and the high prevalence of anxiety and depression in the population, the current study was designed to examine the efficacy of CBT in groups for anxiety and depression in patients with COPD. At present, CBT-based interventions focusing on mental health symptoms are not widely available for COPD patients, and the potential of CBT for improving emotional well-being is not systematically considered in existing treatment alternatives. The study expands the findings from previous pilot studies by focusing on COPD patients with clinically significant levels of anxiety and depression. The wide breadth of coping skills included in the CBT intervention target symptoms of both anxiety and depression, and thus the utility of the intervention for managing mental health symptoms is not restricted to any specific DSM-IV diagnosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Behavioral: Cognitive behavioral therapy7 weekly sessions of group cognitive behavioral therapy |
| B | Active comparator | Behavioral: Minimal Telephone ContactMinimal Telephone Contact |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 40 years or older
- scores of 16 or higher on the Beck Anxiety Inventory and/or 14 or higher on the Beck Depression Inventory II
- COPD diagnosis
Key exclusion criteria (4 listed)
- participation in other studies likely to influence the patient in terms of confounding effects
- signs of cognitive impairment defined by a score of less than 23 on the Mini-Mental State Examination
- presence of psychotic disorders, non-nicotine substance use disorders, bipolar disorders, or suicidal intentions as identified by clinical assessment based on the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (SCID-I/P)
- having a serious somatic condition preventing active participation in the present study
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 |
|---|---|---|
| Cognitive behavioral therapySeven weekly sessions (2 hrs) in groups | Behavioural | A |
| Minimal Telephone ContactTelephone contact (max. 10 minutes) every other week during the 7-week intervention | Behavioural | B |
Primary outcome
Beck Anxiety Inventory
Time frame: Intervention period of 8 weeks, 6 month follow-up
Beck Depression Inventory-II
Time frame: Intervention period of 8 weeks, 6 month follow-up
3 secondary outcomes
St. George's Respiratory Questionnaire
Time frame: Intervention period of 8 weeks, 6 month follow-up
Pittsburgh Sleep Quality Inventory
Time frame: Intervention period of 8 weeks, 6 month follow-up
Actigraphy (Sleep effectiveness)
Time frame: Intervention period of 8 weeks, 6 month follow-up
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 16 Nov 2007.
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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.
Inger Hilde Nordhus, Dr. philos study director
University of Bergen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cognitive behavioral therapy and Minimal Telephone Contact in people with Anxiety and Depression, run by University of Bergen at 1 site in Norway.
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 3 inclusion and 4 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 16 Nov 2007. 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 Norway. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Beck Anxiety Inventory (time frame: Intervention period of 8 weeks, 6 month follow-up). The study lists 2 primary outcomes in all. 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 16 Nov 2007.