NCT00810628

Brief 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 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

First Submitted

Initial submission to the registry

December 17, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 18, 2008

Completed
14 days until next milestone

Study Start

First participant enrolled

January 1, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

October 24, 2014

Status Verified

December 1, 2008

Enrollment Period

8 months

First QC Date

December 17, 2008

Last Update Submit

October 23, 2014

Conditions

Parkinson's DiseaseDepression

Keywords

Parkinson's diseasedepressionParkinson's disease with mild to moderate depression.

Outcome Measures

Primary Outcomes (1)

  • The change in CESD score

    Baseline and 10 weeks

Study Arms (1)

1

EXPERIMENTAL

All subjects in same investigative group with same CBT intervention.

Behavioral: Cognitive Behavioral Therapy

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

Individual interviews and group discussion/training.

1

Eligibility Criteria

Age35 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parkinson's disease, mild to moderate depression, seen at Oregon Health \& Science University

You may not qualify if:

  • Suicidal
  • Cognitive impairment with MOCA \<26

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (1)

  • 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.

    PMID: 17377926BACKGROUND

MeSH Terms

Conditions

Parkinson DiseaseDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Julie H. Carter, MS

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

  • Kristine Hanna, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 17, 2008

First Posted

December 18, 2008

Study Start

January 1, 2009

Primary Completion

September 1, 2009

Study Completion

December 1, 2009

Last Updated

October 24, 2014

Record last verified: 2008-12

Locations

US(1)