NCT01935050

Brief Summary

The purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The manual will be revised based on participant feedback. Several feasibility measures regarding the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness, adherence) will also be assessed. Moreover, preliminary estimates of effect size for this guided self-help program will be calculated and used in future research. We hypothesize that people with PD will report decreases in depression, anxiety, and negative thoughts and improvements in quality life and sleep and that caregivers will report decreases in burden after participating in the guided self-help program

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Apr 2013

Typical duration for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 29, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

December 12, 2017

Status Verified

December 1, 2017

Enrollment Period

3 years

First QC Date

May 29, 2013

Last Update Submit

December 10, 2017

Conditions

DepressionParkinson's Disease

Keywords

DepressionParkinson's diseaseCognitive-Behavioral Treatment

Outcome Measures

Primary Outcomes (1)

  • The Hamilton Depression Rating Scale

    A clinician-administered rating scale for depression

    14 weeks

Secondary Outcomes (8)

  • Beck Depression Inventory

    14 weeks

  • Hamilton Anxiety Rating Scale

    14 weeks

  • Inference Questionnaire

    14 weeks

  • Caregiver Distress Scale

    14 weeks

  • Insomnia Severity Index

    14 weeks

  • +3 more secondary outcomes

Study Arms (1)

Guided Cognitive-Behavioral Self-Help

EXPERIMENTAL

All participants will receive the experimental intervention: Guided Cognitive-Behavioral Self-Help. The 10 patient treatment modules will incorporate exercise, behavioral activation, thought monitoring and restructuring, relaxation training, worry control, and sleep hygiene. The four caregiver educational modules will provide caregivers with the skills needed to facilitate patients' practice of treatment techniques learned in session. For example, caregivers will be taught to help patients identify negative thoughts and replace them with more balanced alternatives and will be given tools to assist patients complete therapy goals (i.e., exercise, socializing).

Behavioral: Guided Cognitive-Behavioral Self-Help

Interventions

Guided Cognitive-Behavioral Self-HelpBEHAVIORAL

Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.

Guided Cognitive-Behavioral Self-Help

Eligibility Criteria

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

You may qualify if:

  • Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
  • Clinically significant depression as determined by study staff
  • years old
  • Stable medication regimen ≥ 6 weeks
  • No change in mental health treatment in past 2 months \_

You may not qualify if:

  • Severe depressive symptoms
  • Suicidal plans or intent
  • Significant cognitive impairment
  • Significant motor fluctuations (i.e., ≥ 50% of the day)
  • Unstable medical conditions
  • Receiving CBT elsewhere

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University-Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

Location

MeSH Terms

Conditions

DepressionParkinson Disease

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorParkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Roseanne D Dobkin, PhD

    Rutgers Robert Wood Johnson Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

May 29, 2013

First Posted

September 4, 2013

Study Start

April 1, 2013

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

December 12, 2017

Record last verified: 2017-12

Locations

US(1)