Telephone-Based Counseling for Depression in Parkinson's Disease
| Status: | Completed |
|---|---|
| Conditions: | Depression, Depression, Parkinsons Disease |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 35 - 85 |
| Updated: | 2/21/2019 |
| Start Date: | July 2015 |
| End Date: | June 30, 2018 |
Improving Access to Depression Care in Parkinson's Disease: A Telehealth Approach
There is a critical need for treatments that address depression and barriers to mental health
care in Parkinson's disease (PD). This randomized-controlled trial will evaluate a 10-session
telephone-guided cognitive behavioral self-help program (TH-CBT) for depression in PD (dPD).
72 people with dPD (and their caregivers) will receive either TH-CBT plus enhanced usual care
(INTERVENTION GROUP) or enhanced usual care only (CONTROL GROUP). Groups will be compared at
baseline, midpoint, endpoint, and 1 and 6 months post-treatment. Participants assigned to the
control group with have the opportunity to receive the experimental intervention (TH-CBT)
after the data collection period (e.g., after the 6-month follow-up evaluation). Given the
public health impact of improved depression treatment in PD, the knowledge to be gained may
be significant and the project could directly impact clinical practice.
care in Parkinson's disease (PD). This randomized-controlled trial will evaluate a 10-session
telephone-guided cognitive behavioral self-help program (TH-CBT) for depression in PD (dPD).
72 people with dPD (and their caregivers) will receive either TH-CBT plus enhanced usual care
(INTERVENTION GROUP) or enhanced usual care only (CONTROL GROUP). Groups will be compared at
baseline, midpoint, endpoint, and 1 and 6 months post-treatment. Participants assigned to the
control group with have the opportunity to receive the experimental intervention (TH-CBT)
after the data collection period (e.g., after the 6-month follow-up evaluation). Given the
public health impact of improved depression treatment in PD, the knowledge to be gained may
be significant and the project could directly impact clinical practice.
All study procedures, including the initial evaluation, study treatment sessions, and
follow-up study assessments, take place over the phone and no travel is required. All PWP
across the USA may participate.
All participants will continue to receive their routine medical treatment under the
supervision of their personal doctors (e.g., neurologists, psychiatrists, primary care
physicians, therapists) while participating in the study. In addition to usual care, half of
the participants in the study will receive the experimental telehealth treatment (TH-CBT;
intervention group), immediately after enrolling in the research program. The other half will
only receive usual care (control group) and will have the option to receive TH-CBT, after
completing all study related assessments (9 months after the initial evaluation). Group
assignment will be decided randomly (i.e., by chance).
Study eligibility will be determined by a qualified professional. Those who qualify for
participation will be randomly assigned (e.g., flip of a coin) to either the intervention
(TH-CBT) or the control group (enhanced usual care).
Participants assigned to the TH-CBT group will receive a 10-chapter CBT self-help treatment
workbook, tailored to the unique needs of people with PD, immediately following enrollment.
Participants will read and complete one treatment module per week (approximately 60 minutes
per module plus practice exercises throughout the week). The treatment materials will review
different coping skills for the effective management of depression. Study therapists will
call participants to review the treatment material over the phone every week (after every
chapter) or every other week (after ever 2 chapters), based on participant needs. These
telephone-based counseling sessions will last 60 minutes. It will take approximately 10 weeks
to complete the study treatment materials.
A family member or friend (carepartner) will also be asked to participate in 3-4 separate
educational sessions (30-60 minutes each), evenly dispersed throughout the 10 week TH-CBT
treatment period. The study treatment provided to the care-partner will teach the
care-partner how to best support the participant with PD as he/she tries to incorporate the
information learned during the study treatment, in day-to-day life.
Participants will be re-evaluated 6, 11, 15, and 35 weeks after the initial evaluation.
follow-up study assessments, take place over the phone and no travel is required. All PWP
across the USA may participate.
All participants will continue to receive their routine medical treatment under the
supervision of their personal doctors (e.g., neurologists, psychiatrists, primary care
physicians, therapists) while participating in the study. In addition to usual care, half of
the participants in the study will receive the experimental telehealth treatment (TH-CBT;
intervention group), immediately after enrolling in the research program. The other half will
only receive usual care (control group) and will have the option to receive TH-CBT, after
completing all study related assessments (9 months after the initial evaluation). Group
assignment will be decided randomly (i.e., by chance).
Study eligibility will be determined by a qualified professional. Those who qualify for
participation will be randomly assigned (e.g., flip of a coin) to either the intervention
(TH-CBT) or the control group (enhanced usual care).
Participants assigned to the TH-CBT group will receive a 10-chapter CBT self-help treatment
workbook, tailored to the unique needs of people with PD, immediately following enrollment.
Participants will read and complete one treatment module per week (approximately 60 minutes
per module plus practice exercises throughout the week). The treatment materials will review
different coping skills for the effective management of depression. Study therapists will
call participants to review the treatment material over the phone every week (after every
chapter) or every other week (after ever 2 chapters), based on participant needs. These
telephone-based counseling sessions will last 60 minutes. It will take approximately 10 weeks
to complete the study treatment materials.
A family member or friend (carepartner) will also be asked to participate in 3-4 separate
educational sessions (30-60 minutes each), evenly dispersed throughout the 10 week TH-CBT
treatment period. The study treatment provided to the care-partner will teach the
care-partner how to best support the participant with PD as he/she tries to incorporate the
information learned during the study treatment, in day-to-day life.
Participants will be re-evaluated 6, 11, 15, and 35 weeks after the initial evaluation.
Inclusion Criteria:
1. Confirmed diagnosis of Parkinson's disease.
2. Clinically significant depressive symptoms (e.g., symptoms are pervasive, distressing,
and make life harder). The presence of a formal depressive disorder will be determined
by study staff based on standardized criteria (e.g., SCID).
3. 35-85 years old
4. Stable medication regimen ≥ 6 weeks
5. No change in mental health treatment in the past 2 months
6. Family member or friend willing to participate
7. Access to a telephone
8. Live in the United States of America (USA)
Exclusion Criteria:
1. Suicidal plans or intent
2. Probable Dementia or Significant Cognitive Impairment
3. Significant motor fluctuations (i.e., ≥ 50% of the day)
4. Unstable medical conditions
5. Bipolar, Psychotic Spectrum, or Substance Abuse Disorders
We found this trial at
1
site
Piscataway, New Jersey 08854
Principal Investigator: Roseanne D Dobkin, PhD
Phone: 732-235-4051
Click here to add this to my saved trials
