Parkinson's DiseaseNCT00810628
Cognitive Behavioral Therapy for Depression in Parkinson's Disease
A study testing Cognitive Behavioral Therapy in people with Parkinson's Disease and Depression, run by Oregon Health and Science University at 1 site in United States.
Trial summary
The purpose of this pilot program is to develop and evaluate a new treatment program for depression in Parkinson's disease (PD). The treatment uses Cognitive Behavior Therapy(CBT)to teach patients how to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related… Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Parkinson's Disease, Depression
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Dec 2009
- 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 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parkinson's disease, mild to moderate depression, seen at Oregon Health \& Science University
Who cannot join
- Suicidal
- Cognitive impairment with MOCA <26
Trial locations and contacts
1 site in 1 country.
United States1 site
Oregon Health & Science University
Portland, Oregon, 97239
About this study
Official title: Depression in Parkinson's Disease: A Pilot Project Using Cognitive Behavioral Therapy (CBT) to Improve Depression and Coping
The purpose of this pilot program is to develop and evaluate a new treatment program for depression in Parkinson's disease (PD). The treatment uses Cognitive Behavior Therapy(CBT)to teach patients how to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to depressive symptoms. This is the first time that this treatment has been used in a group setting for depression in PD.
Target population is patients in the Movement Disorders Clinic at Oregon Health \& Science University who have Parkinson's disease and mild to moderate depression.
- Conditions
- Parkinson's Disease, Depression
- Being tested
- Cognitive Behavioral Therapy
- Keywords
- Parkinson's disease, depression, Parkinson's disease with mild to moderate depression.
- Medical subject headings
- Parkinson Disease, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Individual interviews and group discussion/training.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects in same investigative group with same CBT intervention. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in CESD score
Measured: Baseline and 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionSep 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Collaborators
- National Parkinson Foundation
- Investigators
- Julie H. Carter, MS, Principal investigator, Oregon Health and Science UniversityKristine Hanna, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810628
- Sponsor's protocol ID
- OHSUIRB4613
- Status last verified
- Dec 2008
- First submitted
- 17 Dec 2008
- Last updated
- 24 Oct 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Dobkin RD, Allen LA, Menza M. Cognitive-behavioral therapy for depression in Parkinson's disease: a pilot study. Mov Disord. 2007 May 15;22(7):946-52. doi: 10.1002/mds.21455.
PubMed 17377926
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression in Parkinson's Disease: A Pilot Project Using Cognitive Behavioral Therapy (CBT) to Improve Depression and Coping
- ClinicalTrials.gov ID
- NCT00810628
- Acronym / sponsor ID
- OHSUIRB4613
- Conditions
- Parkinson's Disease, Depression
- Keywords
- Parkinson's disease, depression, Parkinson's disease with mild to moderate depression.
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Collaborators
- National Parkinson Foundation
- Study start
- Jan 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 18 Dec 2008 (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 pilot program is to develop and evaluate a new treatment program for depression in Parkinson's disease (PD). The treatment uses Cognitive Behavior Therapy(CBT)to teach patients how to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to depressive symptoms. This is the first time that this treatment has been used in a group setting for depression in PD.
Target population is patients in the Movement Disorders Clinic at Oregon Health \& Science University who have Parkinson's disease and mild to moderate depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Cognitive Behavioral TherapyAll subjects in same investigative group with same CBT intervention. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Parkinson's disease, mild to moderate depression, seen at Oregon Health \& Science University
Key exclusion criteria (2 listed)
- Suicidal
- Cognitive impairment with MOCA <26
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 TherapyIndividual interviews and group discussion/training. | Behavioural | 1 |
Primary outcome
The change in CESD score
Time frame: Baseline and 10 weeks
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2014.
- Background: PubMed 17377926Dobkin RD, Allen LA, Menza M. Cognitive-behavioral therapy for depression in Parkinson's disease: a pilot study. Mov Disord. 2007 May 15;22(7):946-52. doi: 10.1002/mds.21455.
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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.
Julie H. Carter, MS principal investigator
Oregon Health and Science University
Kristine Hanna, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Parkinson's Disease and Depression, run by Oregon Health and Science University 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 1 inclusion and 2 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: stopped early, as of the sponsor's last update on 24 Oct 2014. 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 was stopped early. Results are not available in the source record.
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?
The change in CESD score (time frame: Baseline and 10 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00810628, which also lists 1 linked publication.
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 24 Oct 2014.