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Guided Self-Help for Depression in Parkinson's Disease

Rutgers The State University of New Jersey logo

Rutgers The State University of New Jersey

Status

Completed

Conditions

Parkinson's Disease
Depression

Treatments

Behavioral: Guided Cognitive-Behavioral Self-Help

Study type

Interventional

Funder types

Other

Identifiers

NCT01935050
2013002798

Details and patient eligibility

About

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

Full description

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.

Enrollment

34 patients

Sex

All

Ages

35 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
  2. Clinically significant depression as determined by study staff
  3. 35-85 years old
  4. Stable medication regimen ≥ 6 weeks
  5. No change in mental health treatment in past 2 months _

Exclusion criteria

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

34 participants in 1 patient group

Guided Cognitive-Behavioral Self-Help
Experimental group
Description:
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).
Treatment:
Behavioral: Guided Cognitive-Behavioral Self-Help

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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