Depression, Parkinson's Disease
Conditions
Keywords
Parkinson's disease, PD, depression, cognitive-behavioral therapy, social support
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALcognitive-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.
Sponsors
National Institute of Neurological Disorders and Stroke (NINDS)
Rutgers, The State University of New Jersey
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hamilton Depression Rating Scale: Baseline | 0 weeks | This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the outset of the trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology. |
| Hamilton Depression Rating Scale: Midpoint | 5 weeks | This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, after 5 weeks of the trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology. |
| Hamilton Depression Rating Scale: Endpoint | 10 weeks | This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the end of the 10 week trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology. |
| Hamilton Depression Rating Scale: Follow-Up Evaluation | 14 weeks | This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, 4 weeks after the trial ended. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cognitive-Behavioral Therapy Condition Participants in the Cognitive-Behavioral Therapy condition will receive 10 weekly individual cognitive-behavioral treatment sessions, lasting one hour each and modified to meet the unique needs of each individual with PD.
These participants will also receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial has ended. During the trial, these participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial. | 41 |
| Standard Medical Care Condition Participants in the Standard Medical Care condition will receive clinical monitoring of their depressive symptoms at 4 points during the trial and once a month after the trial ended. These participants will continue medical or psychiatric care they had been receiving regularly for 6 or more weeks prior to entering the trial, but will not be given any new therapy during the trial. | 39 |
| Total | 80 |
Baseline characteristics
| Characteristic | Cognitive-Behavioral Therapy Condition | Standard Medical Care Condition | Total |
|---|---|---|---|
| Age, Continuous | 63.73 years STANDARD_DEVIATION 9.89 | 65.44 years STANDARD_DEVIATION 11.23 | 64.56 years STANDARD_DEVIATION 10.53 |
| Dementia Rating Scale score | 139.44 units on a scale STANDARD_DEVIATION 3.8 | 136.97 units on a scale STANDARD_DEVIATION 5.5 | 138.24 units on a scale STANDARD_DEVIATION 4.9 |
| Parkinson's disease duration | 6.53 years STANDARD_DEVIATION 5.53 | 6.13 years STANDARD_DEVIATION 5.56 | 6.34 years STANDARD_DEVIATION 5.51 |
| Race/Ethnicity, Customized African American | 0 participants | 1 participants | 1 participants |
| Race/Ethnicity, Customized Asian | 3 participants | 1 participants | 4 participants |
| Race/Ethnicity, Customized Caucasian | 38 participants | 36 participants | 74 participants |
| Race/Ethnicity, Customized Hispanic | 2 participants | 1 participants | 3 participants |
| Race/Ethnicity, Customized Non-Hispanic | 39 participants | 38 participants | 77 participants |
| Race/Ethnicity, Customized Pacific Islander | 0 participants | 1 participants | 1 participants |
| Sex: Female, Male Female | 25 Participants | 23 Participants | 48 Participants |
| Sex: Female, Male Male | 16 Participants | 16 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 41 | 0 / 39 |
| serious Total, serious adverse events | 0 / 41 | 0 / 39 |
Outcome results
Primary
Hamilton Depression Rating Scale: Baseline
This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the outset of the trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.
Time frame: 0 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy Condition | Hamilton Depression Rating Scale: Baseline | 20.93 units on a scale | Standard Deviation 4.56 |
| Standard Medical Care Condition | Hamilton Depression Rating Scale: Baseline | 19.38 units on a scale | Standard Deviation 4.56 |
Primary
Hamilton Depression Rating Scale: Endpoint
This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, at the end of the 10 week trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.
Time frame: 10 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy Condition | Hamilton Depression Rating Scale: Endpoint | 13.58 units on a scale | Standard Deviation 4.72 |
| Standard Medical Care Condition | Hamilton Depression Rating Scale: Endpoint | 19.33 units on a scale | Standard Deviation 4.55 |
Primary
Hamilton Depression Rating Scale: Follow-Up Evaluation
This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, 4 weeks after the trial ended. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.
Time frame: 14 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy Condition | Hamilton Depression Rating Scale: Follow-Up Evaluation | 14.52 units on a scale | Standard Deviation 4.75 |
| Standard Medical Care Condition | Hamilton Depression Rating Scale: Follow-Up Evaluation | 19.31 units on a scale | Standard Deviation 4.63 |
Primary
Hamilton Depression Rating Scale: Midpoint
This measure uses the Hamilton Depression Rating Scale (HDRS) to express the average severity of depressive symptoms for a) all participants in the Cognitive-Behavioral Therapy condition and b) all participants in the Standard Medical Care condition, after 5 weeks of the trial. The total score on the HDRS (range = 0 to 84) was used as the outcome measures value, with higher values indicating more severe depressive symptomatology and lower scores representing less severe depressive symptomatology.
Time frame: 5 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive-Behavioral Therapy Condition | Hamilton Depression Rating Scale: Midpoint | 14.92 units on a scale | Standard Deviation 4.73 |
| Standard Medical Care Condition | Hamilton Depression Rating Scale: Midpoint | 19.71 units on a scale | Standard Deviation 4.56 |