DepressionCOPENCT01337726
Combined Illness Management and Psychotherapy in Treating Depressed Elders
A study testing Combined Psychotherapy and Illness Management and Illness Management Only in people with Depression and Heart Failure, run by University of Iowa at 2 sites in United States.
Trial summary
The purpose of this research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Depression, Heart Failure, Chronic Obstructive Pulmonary Disease
- What is being tested?
- Combined Psychotherapy and Illness Management and Illness Management Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 226 participants
- Where
- 2 sitesUnited States
- Study dates
- Feb 2011to 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 55 years or older
- Diagnosis of Heart Failure or COPD
- Depressive symptoms indicated by a BDI-II score of 10 or higher
- Functional impairment
Who cannot join
- Current psychotherapy
- Cognitive Impairment
- Psychiatric diagnosis
- Active suicidal thoughts
- Significant vision or hearing impairment
- Residence in long term care facility
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Iowa City VA Health Care System
Iowa City, Iowa, 52242
University of Iowa
Iowa City, Iowa, 52242
About this study
The purpose of this research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations.
- Being tested
- Combined Psychotherapy and Illness Management, Illness Management Only
- Keywords
- Depression, Heart Failure, Chronic Obstructive Pulmonary Disease, Quality of Life, Functional Impairment
- Medical subject headings
- Depression, Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined Psychotherapy and Illness ManagementBehavioural
Participants will have 10 weekly visits with a study clinician at their home and by phone. They will focus on their self care and illness management as well as how to manage their mood/cope emotionally. Follow up assessments will occur at 26 and 52 weeks.
Illness Management OnlyBehavioural
Participants in this group will have 10 weekly sessions with a study clinician at home and by phone. They will focus only on how they manage their illness. Follow up assessments will occur at 26 and 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Illness Management Only | Active comparator | Not described Receives: Behavioral: Illness Management Only |
| Combined Psychotherapy & Illness Management | Experimental | Not described Receives: Behavioral: Combined Psychotherapy and Illness Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in depressive symptoms
Change from Baseline in depressive symtoms at 10 weeks
Measured: 10 weeks
Secondary outcomes (1)
Improvement in quality of life/functioning
Change from Baseline in quality of life/functioning at 10 weeks
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by University of IowaThe 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
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Carolyn L Turvey, University of Iowa
- Investigators
- Carolyn L. Turvey, PhD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01337726
- Sponsor's protocol ID
- R01MH086482
- Other IDs
- R01MH086482
- Acronym
- COPE
- Status last verified
- May 2016
- First submitted
- 24 Mar 2011
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Illness Management and Psychotherapy in Treating Depressed Elders
- ClinicalTrials.gov ID
- NCT01337726
- Acronym / sponsor ID
- COPE / R01MH086482
- Keywords
- Depression, Heart Failure, Chronic Obstructive Pulmonary Disease, Quality of Life, Functional Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Feb 2011
- Primary completion
- Mar 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Apr 2011 (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 research study is to test a program developed to help patients with chronic heart or lung problems take care of themselves and cope with their illness or limitations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Illness Management Only | Active comparator | Behavioral: Illness Management Only |
| Combined Psychotherapy & Illness Management | Experimental | Behavioral: Combined Psychotherapy and Illness Management |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 55 years or older
- Diagnosis of Heart Failure or COPD
- Depressive symptoms indicated by a BDI-II score of 10 or higher
- Functional impairment
Key exclusion criteria (6 listed)
- Current psychotherapy
- Cognitive Impairment
- Psychiatric diagnosis
- Active suicidal thoughts
- Significant vision or hearing impairment
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 |
|---|---|---|
| Combined Psychotherapy and Illness ManagementParticipants will have 10 weekly visits with a study clinician at their home and by phone. They will focus on their self care and illness management as well as how to manage their mood/cope emotionally. Follow up assessments will occur at 26 and 52 weeks. | Behavioural | Combined Psychotherapy & Illness Management |
| Illness Management OnlyParticipants in this group will have 10 weekly sessions with a study clinician at home and by phone. They will focus only on how they manage their illness. Follow up assessments will occur at 26 and 52 weeks. | Behavioural | Illness Management Only |
Primary outcome
Reduction in depressive symptoms
Time frame: 10 weeks
Change from Baseline in depressive symtoms at 10 weeks
1 secondary outcome
Improvement in quality of life/functioning
Time frame: 10 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 Apr 2017.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
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.
Carolyn L. Turvey, PhD principal investigator
University of Iowa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined Psychotherapy and Illness Management and Illness Management Only in people with Depression and Heart Failure, run by University of Iowa at 2 sites 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 6 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 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Reduction in depressive symptoms (time frame: 10 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 Apr 2017.