DepressionNCT02552836
Efficacy of Psychotherapy for Depressed Parkinson's Disease Patients
A study testing Interpersonal Psychotherapy and Supportive Psychotherapy in people with Depression and Parkinson's Disease, run by Hopital Montfort at 2 sites in Canada.
Trial summary
The primary aim of this randomized controlled trial is to determine the acute antidepressant efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson's Disease. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Depression, Parkinson's Disease
- What is being tested?
- Interpersonal Psychotherapy and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2016to Mar 2023
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Outpatients with idiopathic Parkinson's disease and between stages 1 and 3 in the modified Hohn \& Yahr Clinical Staging Scale
- Diagnosis of a depressive disorder
- Score ≥ 12 on the 17-item Hamilton Depression Rating Scale
- Living independently
Who cannot join
- History of bipolar disorder or psychotic symptoms (other than drug induced)
- Substance-related disorders in the last 12 months
- Acutely suicidal or history of suicide attempts in the past 5 years
- Presence of cognitive deficits (i.e., score ≤ 24 on the Mini Mental Status Exam) or history of significant cognitive disorders
- Presence of other significant neurological problems
- Presence of unstable comorbid medical conditions
- Currently receiving psychotherapy
- Unable to attend weekly therapy sessions
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
The Ottawa Hospital and University of Ottawa
Ottawa, Ontario, K1K 0T1
The Ottawa Hospital
Ottawa, Ontario, K1Y 4E9
About this study
Official title: Evaluation of Two Psychotherapies for Depressed Patients With Parkinson's Disease
The primary aim of this randomized controlled trial is to determine the acute antidepressant efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson's Disease.
Read the detailed description
The primary aim of this study is to determine whether IPT is more efficacious than an intervention that controls for non-specific factors (i.e., supportive psychotherapy) in reducing depressive symptoms. A secondary aim is to determine whether IPT is better than supportive therapy in improving quality of life, interpersonal functioning, attachment patters, and motor symptoms, and whether treatment gains are durable at 6-months follow-up. An exploratory aim of the study is identify moderators and mediators of treatment outcome. Patients who meet study criteria will be randomly assigned to either 12 sessions of IPT or 12 sessions of supportive therapy. The primary efficacy measure (Hamilton Depression Rating Scale) will be administered at baseline, weeks 6 and 12, and at 6 months follow-up.
- Conditions
- Depression, Parkinson's Disease
- Being tested
- Interpersonal Psychotherapy, Supportive Psychotherapy
- 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.
Interpersonal PsychotherapyBehavioural
A 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms
Supportive PsychotherapyBehavioural
A 12-week intervention that focuses on non-specific factors that contribute to therapy outcome
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy (IPT) | Experimental | Patients assigned to IPT will receive 12 sessions of individual therapy of approximately 50 minutes duration. Therapy will be manualized and slightly adapted to meet the needs of patients with Parkinson's Disease. Therapy focuses on one of four interpersonal events that are linked with onset or maintenance of depression (role transition, role disputes, unresolved grief, and interpersonal deficits). Receives: Behavioral: Interpersonal Psychotherapy |
| Supportive Psychotherapy (SP) | Active comparator | Patients assigned to SP will receive 12 sessions of individual therapy of approximately 50 minutes duration. SP strives to create a supportive therapeutic relationship by emphasizing non-specific therapeutic interactions and techniques. Therapy will be manualized, Receives: Behavioral: Supportive Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hamilton Depression Rating Scale (HAM-A)
17-item clinician rated scale that assesses severity of depressive symptoms
Measured: Change from baseline to week 12 and 6-months follow-up
Secondary outcomes (6)
Beck Depression Inventory (BDI)
The BDI is a self report measure of depressive symptoms
Measured: Change from baseline to week 12 and 6-months follow-up
Beck Anxiety Inventory (BAI)
The BAI is a self-report measure of anxiety symptoms
Measured: Change from baseline to week 12 and 6-months follow-up
Parkinson's Disease Questionnaire (PDQ-39)
Self-report questionnaire that assesses quality of life in patients with Parkinson's Disease
Measured: Change from baseline to week 12 and 6-months follow-up
Interpersonal Relationships Inventory (IPRI)
Self-report inventory that measures aspects of interpersonal relationships
Measured: Change from baseline to week 12 and 6-months follow-up
Experiences in Close Relationship Scale-Revised (ECR-R)
Self-report scale that assesses attachment style in adult relationships
Measured: Change from baseline to week 12 and 6-months follow-up
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Clinician rated scale that provides comprehensive coverage of motor symptoms in Parkinson's Disease
Measured: Change from baseline to week 12 and 6-months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2015 (estimated)
- Study startMar 2016
- Primary completionMar 2023
- Study completionMar 2023
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
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hopital Montfort
- Sponsor type
- University, hospital or other
- Collaborators
- The Ottawa Hospital
- Responsible party
- Sponsor
- Investigators
- Diana Koszycki, PhD, Principal investigator, Montfort Hospital and the University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02552836
- Sponsor's protocol ID
- Montfort Hospital
- Status last verified
- Mar 2024
- First submitted
- 15 Sep 2015
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: No plan to share data
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Two Psychotherapies for Depressed Patients With Parkinson's Disease
- ClinicalTrials.gov ID
- NCT02552836
- Acronym / sponsor ID
- Montfort Hospital
- Conditions
- Depression, Parkinson's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hopital MontfortUniversity, hospital or other
- Collaborators
- The Ottawa Hospital
- Study start
- Mar 2016 (actual)
- Primary completion
- Mar 2023 (actual)
- Study completion
- Mar 2023 (actual)
- First posted
- 17 Sep 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.
The primary aim of this randomized controlled trial is to determine the acute antidepressant efficacy of interpersonal psychotherapy (IPT) in depressed patients with Parkinson's Disease.
Detailed description
The primary aim of this study is to determine whether IPT is more efficacious than an intervention that controls for non-specific factors (i.e., supportive psychotherapy) in reducing depressive symptoms. A secondary aim is to determine whether IPT is better than supportive therapy in improving quality of life, interpersonal functioning, attachment patters, and motor symptoms, and whether treatment gains are durable at 6-months follow-up. An exploratory aim of the study is identify moderators and mediators of treatment outcome. Patients who meet study criteria will be randomly assigned to either 12 sessions of IPT or 12 sessions of supportive therapy. The primary efficacy measure (Hamilton Depression Rating Scale) will be administered at baseline, weeks 6 and 12, and at 6 months follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy (IPT) | Experimental | Behavioral: Interpersonal PsychotherapyPatients assigned to IPT will receive 12 sessions of individual therapy of approximately 50 minutes duration. Therapy will be manualized and slightly adapted to meet the needs of patients with Parkinson's Disease. Therapy focuses on one of four interpersonal events that are linked with onset or maintenance of depression (role transition, role disputes, unresolved grief, and interpersonal deficits). |
| Supportive Psychotherapy (SP) | Active comparator | Behavioral: Supportive PsychotherapyPatients assigned to SP will receive 12 sessions of individual therapy of approximately 50 minutes duration. SP strives to create a supportive therapeutic relationship by emphasizing non-specific therapeutic interactions and techniques. Therapy will be manualized, |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Outpatients with idiopathic Parkinson's disease and between stages 1 and 3 in the modified Hohn \& Yahr Clinical Staging Scale
- Diagnosis of a depressive disorder
- Score ≥ 12 on the 17-item Hamilton Depression Rating Scale
- Living independently
Key exclusion criteria (8 listed)
- History of bipolar disorder or psychotic symptoms (other than drug induced)
- Substance-related disorders in the last 12 months
- Acutely suicidal or history of suicide attempts in the past 5 years
- Presence of cognitive deficits (i.e., score ≤ 24 on the Mini Mental Status Exam) or history of significant cognitive disorders
- Presence of other significant neurological problems
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 |
|---|---|---|
| Interpersonal PsychotherapyA 12-week intervention that focuses on resolving interpersonal stressors that are linked to the onset, maintenance or exacerbation of depressive symptoms | Behavioural | Interpersonal Psychotherapy (IPT) |
| Supportive PsychotherapyA 12-week intervention that focuses on non-specific factors that contribute to therapy outcome | Behavioural | Supportive Psychotherapy (SP) |
Primary outcome
Hamilton Depression Rating Scale (HAM-A)
Time frame: Change from baseline to week 12 and 6-months follow-up
17-item clinician rated scale that assesses severity of depressive symptoms
6 secondary outcomes
Beck Depression Inventory (BDI)
Time frame: Change from baseline to week 12 and 6-months follow-up
Beck Anxiety Inventory (BAI)
Time frame: Change from baseline to week 12 and 6-months follow-up
Parkinson's Disease Questionnaire (PDQ-39)
Time frame: Change from baseline to week 12 and 6-months follow-up
Interpersonal Relationships Inventory (IPRI)
Time frame: Change from baseline to week 12 and 6-months follow-up
Experiences in Close Relationship Scale-Revised (ECR-R)
Time frame: Change from baseline to week 12 and 6-months follow-up
Movement Disorders Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Time frame: Change from baseline to week 12 and 6-months follow-up
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 Mar 2024.
- Individual participant dataSharing planned: No. No plan to share data
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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.
Diana Koszycki, PhD principal investigator
Montfort Hospital and the University of Ottawa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy and Supportive Psychotherapy in people with Depression and Parkinson's Disease, run by Hopital Montfort at 2 sites in Canada.
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 4 inclusion and 8 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 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Hamilton Depression Rating Scale (HAM-A) (time frame: Change from baseline to week 12 and 6-months 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 19 Mar 2024.