Parkinson's DiseasePhase 3NCT01545414
Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease
A Phase 3 study testing ICBT in people with Parkinson's Disease and Depression, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Parkinson's Disease, Depression, Anxiety
- What is being tested?
- ICBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSweden
- Study dates
- Feb 2012to Aug 2013
- Phase
- Phase 3
- 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
- Clinical diagnosis of Parkinson's Disease
- At least mild to moderate depression or anxiety defined as HADS-A or HADS-D > 7
Who cannot join
- Has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview
- Somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders or bipolar disorder)
- Difficulties that hamper the use of a computer
- The patient states difficulties in finding enough time for treatment
- Too low cognitive functioning defined as MoCA < 24
- Too severe depression, defined as MADRS-S over 30
- Too high suicidal risk defined as more than 4 points on the MADRS-S question 9 or according to the structured assessment interview
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
Stockholm
About this study
Official title: Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial
The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.
- Conditions
- Parkinson's Disease, Depression, Anxiety, Insomnia
- Being tested
- ICBT, ICONTROL
- Keywords
- Self-help treatment, Internet treatment, Cognitive Behavioral Therapy, Internet-based Cognitive Behavioral Therapy
- Medical subject headings
- Parkinson Disease, Depression, Anxiety Disorders, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICBTBehavioural
12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
ICONTROLBehavioural
12 weeks of Internet-based treatment with a focus on relaxation training
| Study group | Role | What they receive |
|---|---|---|
| ICBT | Experimental | Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation Receives: Behavioral: ICBT |
| ICONTROL | Active comparator | Internet-based treatment with a focus on relaxation training Receives: Behavioral: ICONTROL |
| SMT | No intervention | Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) in HADS
Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression
Measured: 12 weeks (Post), 3 and 6 months (FU)
Secondary outcomes (6)
Change (from baseline) in MADRS-S
Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression
Measured: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in ISI
Insomnia Severity Index - self-report, to measure insomnia symptoms
Measured: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in PDQ-8
The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients
Measured: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in EQ-5D
EQ-5D, to measure general health and quality of life
Measured: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in SDS
Sheehan Disability Scale, to measure everyday level of functioning
Measured: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in NMSQuest
Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD
Measured: 12 weeks (Post), 3 and 6 months (FU)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Region Stockholm
- Responsible party
- Principal investigator, Viktor Kaldo, Karolinska Institutet
- Investigators
- Viktor Kaldo, Ph.D., Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545414
- Sponsor's protocol ID
- ICBT Parkinson
- Status last verified
- Feb 2015
- First submitted
- 1 Mar 2012
- Last updated
- 13 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01545414
- Acronym / sponsor ID
- ICBT Parkinson
- Conditions
- Parkinson's Disease, Depression, Anxiety, Insomnia
- Keywords
- Self-help treatment, Internet treatment, Cognitive Behavioral Therapy, Internet-based Cognitive Behavioral Therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Feb 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 6 Mar 2012 (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 evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ICBT | Experimental | Behavioral: ICBTInternet-based Cognitive Behavioral Therapy with a focus on behavioral activation |
| ICONTROL | Active comparator | Behavioral: ICONTROLInternet-based treatment with a focus on relaxation training |
| SMT | No intervention | –Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Clinical diagnosis of Parkinson's Disease
- At least mild to moderate depression or anxiety defined as HADS-A or HADS-D > 7
Key exclusion criteria (7 listed)
- Has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview
- Somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders or bipolar disorder)
- Difficulties that hamper the use of a computer
- The patient states difficulties in finding enough time for treatment
- Too low cognitive functioning defined as MoCA < 24
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 |
|---|---|---|
| ICBT12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation | Behavioural | ICBT |
| ICONTROL12 weeks of Internet-based treatment with a focus on relaxation training | Behavioural | ICONTROL |
Primary outcome
Change (from baseline) in HADS
Time frame: 12 weeks (Post), 3 and 6 months (FU)
Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression
6 secondary outcomes
Change (from baseline) in MADRS-S
Time frame: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in ISI
Time frame: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in PDQ-8
Time frame: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in EQ-5D
Time frame: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in SDS
Time frame: 12 weeks (Post), 3 and 6 months (FU)
Change (from baseline) in NMSQuest
Time frame: 12 weeks (Post), 3 and 6 months (FU)
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 13 Feb 2015.
- The public page of the Internet-CBT treatment platformLink provided by the sponsor.
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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.
Viktor Kaldo, Ph.D. principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing ICBT in people with Parkinson's Disease and Depression, run by Karolinska Institutet at 1 site in Sweden.
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 2 inclusion and 7 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 13 Feb 2015. 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 Sweden. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change (from baseline) in HADS (time frame: 12 weeks (Post), 3 and 6 months (FU)). 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 13 Feb 2015.