Coping With Depression in Parkinson's Disease

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2013-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to evaluate the efficacy of a cognitive-behavioral treatment, that includes a caregiver-focused social support intervention, for depression in persons with Parkinson's disease.

Individuals who are unable to travel to the study site, but are interested in participating and meet all other eligibility requirements, will be allowed to participate over the phone.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Guided Self-Help for Depression in Parkinson's Disease

NCT01935050

Depression Parkinson's Disease

COMPLETED NA

Barriers to Mental Healthcare Utilization in Parkinson's Disease

NCT01167608

Parkinson's Disease Depression Anxiety

COMPLETED

Psychiatric and Cognitive Manifestations of Parkinson's Disease

NCT00360633

Parkinson's Disease

COMPLETED

tDCS on Parkinson's Disease Cognition

NCT03025334

Parkinson Disease Mild Cognitive Impairment

RECRUITING NA

Online Cognitive Behavioral Therapy for Depressive Symptoms in Parkinson's Disease

NCT05585827

Parkinson Disease Depressive Symptoms Anxiety

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Depression is the most common emotional problem found in persons with Parkinson's disease (PD). It causes immense personal suffering and is associated with increased disability and burden to caregivers. Despite the adverse consequences of depression in PD, there are virtually no studies to guide clinical treatment. Several studies are currently examining the effectiveness of antidepressant medication for depression in PD. However, there have been no studies to examine the effectiveness of non-medication approaches, such as cognitive-behavioral therapy, despite the success of these techniques in other populations. Cognitive-behavioral therapy teaches people with PD to become more aware of their thoughts and feelings and to change thinking patterns and behaviors that may be related to symptoms of depression.

The purpose of this study is to determine if cognitive-behavioral therapy--with a caregiver-focused social support intervention--is effective in treating depression in persons with PD. This study will enroll 80 people with PD and their caregivers. Forty participants with PD will be randomly chosen to receive the study treatment in addition to standard medical care. The other 40 will only receive standard medical care and will have the option to receive the study treatment after completing all study assessments (4 months after the initial evaluation).

The study treatment will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD. Caregivers will attend 4 separate educational sessions-lasting 30 minutes each--designed to provide them with the tools needed to reinforce and supplement the material presented in the cognitive-behavioral sessions. Duration of the study for participants is 15 weeks.

This is the first study to evaluate the impact of a cognitive-behavioral treatment for PD depression in a randomized controlled trial. Information gained from this study may be beneficial in treating depression in persons with PD.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Parkinson's Disease Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

cognitive-behavioral therapy

Group Type ACTIVE_COMPARATOR

cognitive-behavioral therapy

Intervention Type BEHAVIORAL

The therapy will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD.

2

standard medical care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cognitive-behavioral therapy

The therapy will consist of 10 weekly individual cognitive-behavioral treatment sessions, lasting 1 hour each and modified to meet the unique needs of each individual with PD.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Confirmed diagnosis of PD with no significant motor fluctuations or dementia.
* Major Depression, Dysthymia, or Depression NOS (Clinically significant depression not otherwise specified).
* 35-85 years old.
* Willingness to ask a family member or friend, with whom the patient has regular contact, to be involved in treatment.
* Patients will be allowed to remain on antidepressant medications that have been stabilized (e.g., no dose changes) for at least 6 weeks prior to screening provided that they do not have plans to change these medications while in the study.
* Patients will be allowed to remain on sedative-hypnotics or anxiolytics that have been stabilized for at least 4 weeks prior to screening. Patients who are taking these medications at screening and qualify for participation will be asked to remain on a stable course of these medications throughout the trial.
* Taking a stable dose of dopaminergic replacement therapy for at least one month

* Ages 25 to 85
* Daily contact with a friend, family member, or spouse with depression and PD \*MMSE \> 26 \[Mini Mental Status Exam score of greater than 26 (i.e., no signs of significant memory impairment)\].

Exclusion Criteria

* DSM-IV criteria for a psychotic disorder, bipolar disorder, organic brain syndrome, or psychoactive substance dependence or abuse (Nicotine or caffeine dependence is allowed). Other psychiatric co-morbidity is not exclusionary as long as the depressive disorder is primary.
* Active suicidal ideation.
* An unstable major medical condition that would interfere with the study.
* Plans to engage in additional psychotherapy during the study (PD support group is ok).
* A diagnosis of dementia, defined as above.
* Significant motor fluctuations, defined as above; mild end of dose wearing off is allowed.
* Patients unwilling or unable to maintain a stable dose of dopaminergic replacement therapy during the trial.
* Use of mood-stabilizers or antipsychotic medication.

* Active suicidal ideation
* An unstable major medical or psychiatric condition
* Evidence upon clinical interview of substance abuse/dependence

Minimum Eligible Age

35 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes