Coping With Depression in Parkinson's Disease

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 160 persons—80 with PD and 80 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.

Persons with PD 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

Persons with PD 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.

Caregiver Inclusion Criteria:

- 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)].

Caregiver Exclusion Criteria:

- Active suicidal ideation

- An unstable major medical or psychiatric condition

- Evidence upon clinical interview of substance abuse/dependence