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Completed

NCT Number: NCT01935050

Guided Self-Help for Depression in Parkinson's Disease

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

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Key information

Conditions

Depression Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinson's Disease Parkinsonian Disorders Synucleinopathies

Age range

35 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rutgers University-Robert Wood Johnson Medical School

Piscataway, New Jersey, 08854, United States

About this study

To our knowledge, Cognitive-Behavioral self-help interventions remain unexplored for depression in PD to date. The results of this study will be used to support future treatment development efforts for depression and other psychiatric complications in PD that may improve the access to and quality of mental health care in this medical population.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
  • Clinically significant depression as determined by study staff
  • 35-85 years old
  • Stable medication regimen ≥ 6 weeks
  • No change in mental health treatment in past 2 months _

Exclusion criteria

  • 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

Treatment and study plan

Guided Cognitive-Behavioral Self-Help

Behavioral

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

Primary outcomes

  1. The Hamilton Depression Rating Scale

    Time frame: 14 weeks

    A clinician-administered rating scale for depression

Secondary outcomes

  1. Beck Depression Inventory

    Time frame: 14 weeks

    A self-report measure of depression

  2. Hamilton Anxiety Rating Scale

    Time frame: 14 weeks

    A clinician-administered rating scale of anxiety

  3. Inference Questionnaire

    Time frame: 14 weeks

    Self-report measure of negative thoughts

  4. Caregiver Distress Scale

    Time frame: 14 weeks

    Self-report measure of caregiver stress

  5. Insomnia Severity Index

    Time frame: 14 weeks

    Self-report sleep scale

  6. Medical Outcomes Short Form

    Time frame: 14 weeks

    Self-report quality of life scale

  7. Feasibility and adherence measures

    Time frame: 10 weeks

    Feasibility [Likert ratings (0-10) on the dimensions of readability, clarity, effort, enjoyment, fatigue, helpfulness, and progress regarding treatment materials] and adherence measures [a numerical rating regarding the % of recommended activities accomplished]

  8. Clinical Global Impression-Improvement Scale

    Time frame: 14 weeks

    Clinician-rated scale of depression improvement

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

A Guided Cognitive-Behavioral Self-Help Treatment for Depression in Parkinson's Disease

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Sep 4, 2013
Registry last updated
Dec 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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