DepressionTH-CBTNCT02505737
Telephone-Based Counseling for Depression in Parkinson's Disease
A study testing TH-CBT in people with Depression and Parkinson's Disease, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 35 to 85 years
- Conditions the study is for
- Depression, Parkinson's Disease
- What is being tested?
- TH-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of Parkinson's disease.
- 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).
- 35-85 years old
- Stable medication regimen ≥ 6 weeks
- No change in mental health treatment in the past 2 months
- Family member or friend willing to participate
- Access to a telephone
- Live in the United States of America (USA)
Who cannot join
- Suicidal plans or intent
- Probable Dementia or Significant Cognitive Impairment
- Significant motor fluctuations (i.e., ≥ 50% of the day)
- Unstable medical conditions
- Bipolar, Psychotic Spectrum, or Substance Abuse Disorders
Trial locations and contacts
1 site in 1 country.
United States1 site
Rutgers University-Robert Wood Johnson Medical School
Piscataway, New Jersey, 08854
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Depression, Parkinson's Disease
- Being tested
- TH-CBT, Enhanced Usual Care
- Medical subject headings
- Depression, Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TH-CBTBehavioural
Telephone-Based Cognitive Behavioral Therapy (TH-CBT). A 10-session treatment protocol that incorporates behavioral activation, thought monitoring and restructuring, relaxation training, worry control, sleep hygiene, and caregiver psychoeducation and support
Enhanced Usual CareOther
Community-based treatment as usual and supplemental reading material
| Study group | Role | What they receive |
|---|---|---|
| TH-CBT | Experimental | The treatment works by teaching people with PD (PWP) the coping skills needed to manage their emotional reactions to the numerous challenges posed by the disease. Specifically, the treatment targets maladaptive thought patterns (e.g., I have no control; I am helpless) and behaviors (e.g., social isolation, lack of exercise, poor sleep habits, excessive worry), and critically, provides caregivers with the tools needed to encourage the PWPs' practice of their newly acquired coping skills. Treatment is administered over the phone and no travel is required. Receives: Behavioral: TH-CBT |
| Enhanced Usual Care | Other | 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. This routine treatment (e.g., usual care) will be further enhanced with the provision of written educational materials for effective coping with PD, the close clinical monitoring of depressive symptoms by study staff, and the provision of counseling resources in the local community. Receives: Other: Enhanced Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression on the Hamilton Depression Rating Scale
clinician-administered scale- depression
Measured: 9 months
Secondary outcomes (3)
Treatment Response on the Clinical Global Impression- Improvement Scale
clinician-administered scale- treatment response
Measured: 9- months
Anxiety on the Hamilton Anxiety Rating Scale
clinician administered scale-anxiety
Measured: 9-months
Quality of life on the SF-36
self-report scale- quality of life
Measured: 9-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study startJul 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Roseanne D Dobkin, PhD, Rutgers, The State University of New Jersey
- Investigators
- Roseanne D Dobkin, PhD, Principal investigator, Rutgers Robert Wood Johnson Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02505737
- Sponsor's protocol ID
- 20150001714
- Acronym
- TH-CBT
- Status last verified
- Feb 2019
- First submitted
- 21 Jul 2015
- Last updated
- 19 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Dobkin RD, Mann SL, Gara MA, Interian A, Rodriguez KM, Menza M. Telephone-based cognitive behavioral therapy for depression in Parkinson disease: A randomized controlled trial. Neurology. 2020 Apr 21;94(16):e1764-e1773. doi: 10.1212/WNL.0000000000009292. Epub 2020 Apr 1.
PubMed 32238507
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Access to Depression Care in Parkinson's Disease: A Telehealth Approach
- ClinicalTrials.gov ID
- NCT02505737
- Acronym / sponsor ID
- TH-CBT / 20150001714
- Conditions
- Depression, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Jul 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TH-CBT | Experimental | Behavioral: TH-CBTThe treatment works by teaching people with PD (PWP) the coping skills needed to manage their emotional reactions to the numerous challenges posed by the disease. Specifically, the treatment targets maladaptive thought patterns (e.g., I have no control; I am helpless) and behaviors (e.g., social isolation, lack of exercise, poor sleep habits, excessive worry), and critically, provides caregivers with the tools needed to encourage the PWPs' practice of their newly acquired coping skills. Treatment is administered over the phone and no travel is required. |
| Enhanced Usual Care | Other | Other: Enhanced Usual CareAll 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. This routine treatment (e.g., usual care) will be further enhanced with the provision of written educational materials for effective coping with PD, the close clinical monitoring of depressive symptoms by study staff, and the provision of counseling resources in the local community. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Confirmed diagnosis of Parkinson's disease.
- 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).
- 35-85 years old
- Stable medication regimen ≥ 6 weeks
- No change in mental health treatment in the past 2 months
Key exclusion criteria (5 listed)
- Suicidal plans or intent
- Probable Dementia or Significant Cognitive Impairment
- Significant motor fluctuations (i.e., ≥ 50% of the day)
- Unstable medical conditions
- Bipolar, Psychotic Spectrum, or Substance Abuse Disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TH-CBTTelephone-Based Cognitive Behavioral Therapy (TH-CBT). A 10-session treatment protocol that incorporates behavioral activation, thought monitoring and restructuring, relaxation training, worry control, sleep hygiene, and caregiver psychoeducation and support | Behavioural | TH-CBT |
| Enhanced Usual CareCommunity-based treatment as usual and supplemental reading material | Other | Enhanced Usual Care |
Primary outcome
Depression on the Hamilton Depression Rating Scale
Time frame: 9 months
clinician-administered scale- depression
3 secondary outcomes
Treatment Response on the Clinical Global Impression- Improvement Scale
Time frame: 9- months
Anxiety on the Hamilton Anxiety Rating Scale
Time frame: 9-months
Quality of life on the SF-36
Time frame: 9-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 32238507Dobkin RD, Mann SL, Gara MA, Interian A, Rodriguez KM, Menza M. Telephone-based cognitive behavioral therapy for depression in Parkinson disease: A randomized controlled trial. Neurology. 2020 Apr 21;94(16):e1764-e1773. doi: 10.1212/WNL.0000000000009292. Epub 2020 Apr 1.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Roseanne D Dobkin, PhD principal investigator
Rutgers Robert Wood Johnson Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TH-CBT in people with Depression and Parkinson's Disease, run by Rutgers, The State University of New Jersey at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression on the Hamilton Depression Rating Scale (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02505737, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2019.