DepressionNCT03993041
Telehealth Psychotherapy for Depression in Parkinson's Disease
A study testing Cognitive-behavioral therapy (CBT) in people with Depression and Parkinson's Disease, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
Depression is a prevalent non-motor symptom of Parkinson's disease (PD). Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for depression in PD. CBT is usually administered in-person in weekly sessions, but PD motor disability, stigma, and transportation issues may prevent attending such… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Depression, Parkinson's Disease
- What is being tested?
- Cognitive-behavioral therapy (CBT)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 30 Apr 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Idiopathic Parkinson's disease (PD), any subtype
- Depression
- Internet access and a webcam
- For psychotropic and dopaminergic medications, participants may enroll only if they are stable for at least 6 weeks and 2 weeks, respectively, before beginning the study
- The investigators will enroll only depressed individuals with PD who are not already receiving or are willing to stop other ongoing psychotherapy before beginning this treatment study
Who cannot join
- Serious chronic medical or neurological illness, other than PD
- History of traumatic brain injury
- Mental retardation
- Current or recent (past 90 days) history of substance abuse or drug dependence, with the exception of nicotine, marijuana, and caffeine
- Active suicidal or homicidal ideation or intent
- Dementia
Show all 10Show fewer
- Current DSM-5 diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, or substance/medication-induced disorder
- Previous experience with an adequate trial of cognitive-behavioral therapy (8 sessions within the past 5 years
- Concurrent psychosocial treatment (i.e., therapy) focused on depression, anxiety, or other related disorders, or are not willing to refrain from initiating additional therapy during the study
- Concurrent psychotropic medications if not stabilized or not willing to maintain a stable dosage of psychotropic medications, such as medications for depression or anxiety, during study participation
Trial locations and contacts
1 site in 1 country.
United States1 site
Vision & Cognition Laboratory
Boston, Massachusetts, 02215
About this study
Depression is a prevalent non-motor symptom of Parkinson's disease (PD). Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for depression in PD. CBT is usually administered in-person in weekly sessions, but PD motor disability, stigma, and transportation issues may prevent attending such therapy sessions. CBT administered via live videoconference technology may allow the treatment of depression, while circumventing the barriers that deter those with PD from seeking psychological services. The investigators propose that videoconference CBT will improve mood in individuals with PD who have depression.
Read the detailed description
The investigators plan to conduct a randomized control trial with 12 participants. Six (PD-early) will receive three assessments: baseline, immediately post-treatment (post1), and 6 weeks after treatment (post2). The other six (PD-waitlist) will have an additional assessment (Baseline 2; 12 weeks after Baseline 1) to examine practice effects before beginning treatment, and then will have the post1 and post2 assessments (four assessments).
- Conditions
- Depression, Parkinson's Disease
- Being tested
- Cognitive-behavioral therapy (CBT)
- 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.
Cognitive-behavioral therapy (CBT)Behavioural
Study therapists will deliver cognitive-behavioral therapy (CBT) based on an emotion-focused, transdiagnostic protocol. CBT targets problematic thoughts, feelings, and behaviors through goal-oriented, systematic procedures. The intervention used in this study is designed to target emotional processing with an emphasis on present-focused awareness, cognitive flexibility, emotional avoidance, awareness and tolerance of physical sensations, and situation-based emotion exposure. The intervention is designed to help individuals better understand emotional experiences in order to respond to intense emotions in a more adaptive way.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive-behavioral therapy (CBT) | Experimental | Individuals in the CBT arm are expected to participate in a phone screen + baseline phase (one assessment) + 10-12 weeks of CBT intervention + post-intervention assessment + 6 week follow-up assessment. Receives: Behavioral: Cognitive-behavioral therapy (CBT) |
| Waitlist Control | Active comparator | Individuals in the Waitlist Control arm are expected to participate in a phone screen + baseline phase (two assessments, 12 weeks apart) + 10-12 weeks of CBT intervention + post-intervention assessment + 6 week follow-up assessment. Receives: Behavioral: Cognitive-behavioral therapy (CBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety and Related Disorders Interview Schedule for DSM-5
Semi-structured diagnostic interview for assessment of mood and related disorders.
Measured: Change in diagnosis of depression from baseline to post-treatment (approximately 12 weeks after baseline) and 6-week follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Aug 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
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.
- 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
- Care provider
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alice Cronin-Golomb, Boston University Charles River Campus
- Investigators
- Alice Cronin-Golomb, Ph.D., Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03993041
- Sponsor's protocol ID
- 5222
- Status last verified
- Aug 2022
- First submitted
- 16 Jun 2019
- Last updated
- 8 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telehealth Psychotherapy for Depression in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT03993041
- Acronym / sponsor ID
- 5222
- Conditions
- Depression, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 20 Jun 2019 (actual)
- 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.
Depression is a prevalent non-motor symptom of Parkinson's disease (PD). Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment for depression in PD. CBT is usually administered in-person in weekly sessions, but PD motor disability, stigma, and transportation issues may prevent attending such therapy sessions. CBT administered via live videoconference technology may allow the treatment of depression, while circumventing the barriers that deter those with PD from seeking psychological services. The investigators propose that videoconference CBT will improve mood in individuals with PD who have depression.
Detailed description
The investigators plan to conduct a randomized control trial with 12 participants. Six (PD-early) will receive three assessments: baseline, immediately post-treatment (post1), and 6 weeks after treatment (post2). The other six (PD-waitlist) will have an additional assessment (Baseline 2; 12 weeks after Baseline 1) to examine practice effects before beginning treatment, and then will have the post1 and post2 assessments (four assessments).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive-behavioral therapy (CBT) | Experimental | Behavioral: Cognitive-behavioral therapy (CBT)Individuals in the CBT arm are expected to participate in a phone screen + baseline phase (one assessment) + 10-12 weeks of CBT intervention + post-intervention assessment + 6 week follow-up assessment. |
| Waitlist Control | Active comparator | Behavioral: Cognitive-behavioral therapy (CBT)Individuals in the Waitlist Control arm are expected to participate in a phone screen + baseline phase (two assessments, 12 weeks apart) + 10-12 weeks of CBT intervention + post-intervention assessment + 6 week follow-up assessment. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Idiopathic Parkinson's disease (PD), any subtype
- Depression
- Internet access and a webcam
- For psychotropic and dopaminergic medications, participants may enroll only if they are stable for at least 6 weeks and 2 weeks, respectively, before beginning the study
- The investigators will enroll only depressed individuals with PD who are not already receiving or are willing to stop other ongoing psychotherapy before beginning this treatment study
Key exclusion criteria (10 listed)
- Serious chronic medical or neurological illness, other than PD
- History of traumatic brain injury
- Mental retardation
- Current or recent (past 90 days) history of substance abuse or drug dependence, with the exception of nicotine, marijuana, and caffeine
- Active suicidal or homicidal ideation or intent
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 |
|---|---|---|
| Cognitive-behavioral therapy (CBT)Study therapists will deliver cognitive-behavioral therapy (CBT) based on an emotion-focused, transdiagnostic protocol. CBT targets problematic thoughts, feelings, and behaviors through goal-oriented, systematic procedures. The intervention used in this study is designed to target emotional processing with an emphasis on present-focused awareness, cognitive flexibility, emotional avoidance, awareness and tolerance of physical sensations, and situation-based emotion exposure. The intervention is designed to help individuals better understand emotional experiences in order to respond to intense emotions in a more adaptive way. | Behavioural | Cognitive-behavioral therapy (CBT), Waitlist Control |
Primary outcome
Anxiety and Related Disorders Interview Schedule for DSM-5
Time frame: Change in diagnosis of depression from baseline to post-treatment (approximately 12 weeks after baseline) and 6-week follow-up.
Semi-structured diagnostic interview for assessment of mood and related disorders.
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 8 Aug 2022.
- Individual participant dataSharing planned: No
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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.
Alice Cronin-Golomb, Ph.D. principal investigator
Boston University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive-behavioral therapy (CBT) in people with Depression and Parkinson's Disease, run by Boston University Charles River Campus 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 10 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 8 Aug 2022. 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?
Anxiety and Related Disorders Interview Schedule for DSM-5 (time frame: Change in diagnosis of depression from baseline to post-treatment (approximately 12 weeks after baseline) and 6-week follow-up.). 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 8 Aug 2022.