DepressionNCT01935050
Guided Self-Help for Depression in Parkinson's Disease
A study testing Guided Cognitive-Behavioral Self-Help 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
The purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The manual will be revised based on participant feedback. 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?
- Guided Cognitive-Behavioral Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Apr 2016
- 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
- Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
- Clinically significant depression as determined by study staff
- 35-85 years old
- Stable medication regimen ≥ 6 weeks
- No change in mental health treatment in past 2 months _
Who cannot join
- Severe depressive symptoms
- Suicidal plans or intent
- Significant cognitive impairment
- Significant motor fluctuations (i.e., ≥ 50% of the day)
- Unstable medical conditions
- Receiving CBT elsewhere
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: A Guided Cognitive-Behavioral Self-Help Treatment for Depression in Parkinson's Disease
The purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The manual will be revised based on participant feedback. Several feasibility measures regarding the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness, adherence) will also be assessed. Moreover, preliminary estimates of effect size for this guided self-help program will be calculated and used in future research. We hypothesize that people with PD will report decreases in depression, anxiety, and negative thoughts and improvements in quality life and sleep and that caregivers will report decreases in burden after participating in the guided self-help program
Read the detailed description
To our knowledge, Cognitive-Behavioral self-help interventions remain unexplored for depression in PD to date. The results of this study will be used to support future treatment development efforts for depression and other psychiatric complications in PD that may improve the access to and quality of mental health care in this medical population.
- Conditions
- Depression, Parkinson's Disease
- Being tested
- Guided Cognitive-Behavioral Self-Help
- Keywords
- Depression, Parkinson's disease, Cognitive-Behavioral Treatment
- 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.
Guided Cognitive-Behavioral Self-HelpBehavioural
Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.
| Study group | Role | What they receive |
|---|---|---|
| Guided Cognitive-Behavioral Self-Help | Experimental | All participants will receive the experimental intervention: Guided Cognitive-Behavioral Self-Help. The 10 patient treatment modules will incorporate exercise, behavioral activation, thought monitoring and restructuring, relaxation training, worry control, and sleep hygiene. The four caregiver educational modules will provide caregivers with the skills needed to facilitate patients' practice of treatment techniques learned in session. For example, caregivers will be taught to help patients identify negative thoughts and replace them with more balanced alternatives and will be given tools to assist patients complete therapy goals (i.e., exercise, socializing). Receives: Behavioral: Guided Cognitive-Behavioral Self-Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Hamilton Depression Rating Scale
A clinician-administered rating scale for depression
Measured: 14 weeks
Secondary outcomes (8)
Beck Depression Inventory
A self-report measure of depression
Measured: 14 weeks
Hamilton Anxiety Rating Scale
A clinician-administered rating scale of anxiety
Measured: 14 weeks
Inference Questionnaire
Self-report measure of negative thoughts
Measured: 14 weeks
Caregiver Distress Scale
Self-report measure of caregiver stress
Measured: 14 weeks
Insomnia Severity Index
Self-report sleep scale
Measured: 14 weeks
Medical Outcomes Short Form
Self-report quality of life scale
Measured: 14 weeks
Feasibility and adherence measures
Feasibility [Likert ratings (0-10) on the dimensions of readability, clarity, effort, enjoyment, fatigue, helpfulness, and progress regarding treatment materials] and adherence measures [a numerical rating regarding the % of recommended activities accomplished]
Measured: 10 weeks
Clinical Global Impression-Improvement Scale
Clinician-rated scale of depression improvement
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- 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
- NCT01935050
- Sponsor's protocol ID
- 2013002798
- Status last verified
- Dec 2017
- First submitted
- 29 May 2013
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Guided Cognitive-Behavioral Self-Help Treatment for Depression in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT01935050
- Acronym / sponsor ID
- 2013002798
- Conditions
- Depression, Parkinson's Disease
- Keywords
- Depression, Parkinson's disease, Cognitive-Behavioral Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 4 Sep 2013 (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.
The purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The manual will be revised based on participant feedback. Several feasibility measures regarding the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness, adherence) will also be assessed. Moreover, preliminary estimates of effect size for this guided self-help program will be calculated and used in future research. We hypothesize that people with PD will report decreases in depression, anxiety, and negative thoughts and improvements in quality life and sleep and that caregivers will report decreases in burden after participating in the guided self-help program
Detailed description
To our knowledge, Cognitive-Behavioral self-help interventions remain unexplored for depression in PD to date. The results of this study will be used to support future treatment development efforts for depression and other psychiatric complications in PD that may improve the access to and quality of mental health care in this medical population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guided Cognitive-Behavioral Self-Help | Experimental | Behavioral: Guided Cognitive-Behavioral Self-HelpAll participants will receive the experimental intervention: Guided Cognitive-Behavioral Self-Help. The 10 patient treatment modules will incorporate exercise, behavioral activation, thought monitoring and restructuring, relaxation training, worry control, and sleep hygiene. The four caregiver educational modules will provide caregivers with the skills needed to facilitate patients' practice of treatment techniques learned in session. For example, caregivers will be taught to help patients identify negative thoughts and replace them with more balanced alternatives and will be given tools to assist patients complete therapy goals (i.e., exercise, socializing). |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist
- Clinically significant depression as determined by study staff
- 35-85 years old
- Stable medication regimen ≥ 6 weeks
- No change in mental health treatment in past 2 months _
Key exclusion criteria (6 listed)
- Severe depressive symptoms
- Suicidal plans or intent
- Significant cognitive impairment
- Significant motor fluctuations (i.e., ≥ 50% of the day)
- Unstable medical conditions
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 |
|---|---|---|
| Guided Cognitive-Behavioral Self-HelpParticipants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff. | Behavioural | Guided Cognitive-Behavioral Self-Help |
Primary outcome
The Hamilton Depression Rating Scale
Time frame: 14 weeks
A clinician-administered rating scale for depression
8 secondary outcomes
Beck Depression Inventory
Time frame: 14 weeks
Hamilton Anxiety Rating Scale
Time frame: 14 weeks
Inference Questionnaire
Time frame: 14 weeks
Caregiver Distress Scale
Time frame: 14 weeks
Insomnia Severity Index
Time frame: 14 weeks
Medical Outcomes Short Form
Time frame: 14 weeks
Feasibility and adherence measures
Time frame: 10 weeks
Clinical Global Impression-Improvement Scale
Time frame: 14 weeks
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 12 Dec 2017.
Related trials for Depression
Recruiting
Regulated Stimulation for Optimized Network Activity and Therapeutic Equilibrium
Major Depressive Disorder
Recruiting
Metacognitive Bibliotherapy for Anxiety, Depression, and Metacognitions in University Students
Anxiety, Depression
Enrolling by invitation
Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement
Treatment Resistant Depression
Active, not recruiting
NYUCI-ES: Psychosocial Intervention to Improve Health Outcomes for Chinese and Korean ADRD Caregivers
Dementia Caregivers, Diabetes
Enrolling by invitation
Intervention to Reduce HIV Related Stigma Among Pregnant and Postpartum Women
HIV, HIV - Human Immunodeficiency Virus
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 Guided Cognitive-Behavioral Self-Help 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 5 inclusion and 6 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 12 Dec 2017. 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?
The Hamilton Depression Rating Scale (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Dec 2017.