Parkinson DiseasePatrikNCT02627885
Internet-CBT for Parkinsons Disease
A study testing Internet-based CBT and SMT in people with Parkinson Disease, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The aim of the study is to investigate if an Internet-based psychological treatment based on principles from Cognitive Behavioral Therapy can increase function and quality of life for patients with Parkinson disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Internet-based CBT and SMT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 77 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2015to Mar 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed Parkinson disease
- WSAS score of over 17
- Access to a internet connected device and a mobile phone capable of receiving SMS
Who cannot join
- Substance or alcohol abuse
- Psychotic Disorder or Bipolar disorder
- Other psychiatric disorder that requires immediate attention or hinders the offered ICBT treatment
- Practical obstacles such as difficulties using the technology required to participate in the study, not having the time to actively wok with the treatment, or having symptoms from Parkinson to severe to be able to actively participate in the study
- High suicide risk, defined as:
- 5 or 6 points on the question about Suicidal thoughts on the Montgomery-Asberg Depression Scale (MADRS)
- A standardized clinical interview on suicidal thoughts if the score on the above question is 4
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
Stockholm
About this study
Official title: Internet-based Cognitive Behavioral Therapy to Increase Function and Quality of Life for Patients With Parkinsons Disease
The aim of the study is to investigate if an Internet-based psychological treatment based on principles from Cognitive Behavioral Therapy can increase function and quality of life for patients with Parkinson disease.
Read the detailed description
The Internet-based Cognitive Behavioral Therapy (ICBT) will be given as an adjunct to the Standard Medical Treatment. ICBT will be compared to Standard Medical Treatment alone (SMT).
A secondary aim is make a preliminary evaluation of the ICBT-program with less and less active therapist support. It is hypothesized that both active treatments will be superior to SMT in improving quality of life and functioning and that ICBT with full therapist support will be superior to ICBT with lower level of therapist support.
- Conditions
- Parkinson Disease
- Being tested
- Internet-based CBT, SMT
- Keywords
- internet treatment, cognitive behavioral therapy, level of functioning, quality of life
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet-based CBTBehavioural
Through the use of CBT material at an Internet-platform, we aim for behavioral changes in the subjects to improve everyday level of functioning and quality of life.
SMTOther
Standard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions
| Study group | Role | What they receive |
|---|---|---|
| ICBT | Active comparator | Internet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment Receives: Behavioral: Internet-based CBT |
| SMT | Other | Standard Medical Treatment for Parkinsons Disease only Receives: Other: SMT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change (from baseline) in WSAS
The Work and Social Adjustment Scale. Self-administered, measures impairment in functioning
Measured: Baseline, nine weekly measure while in treatment, then the primary endpoint is after 10 weeks of treatment (Post), and there will also be up to two follow-up (FU) measures within 3 years from treatment completion
Secondary outcomes (8)
Change (from baseline) in IPAQ
International Physical Activity Questionnaire. Self-administered, measures physical activity
Measured: Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in SVAQ
Swedish Valued Activity Questionnaire. Self-administered, measures valued activities
Measured: Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in WHODAS-2
World Health Organization Disability Assessment Schedule 2 (12-item). Self-administered, measures disability
Measured: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in PDQ-8
Parkinson's Disease Questionnaire-8. Self-administered, measures functioning and well-being patients with Parkinsons disease
Measured: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in BBQ
Brunnsviken Brief Quality of life scale. Self-administered, measures quality of life
Measured: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in HADS
The Hospital Anxiety and Depression Scale. Self-administered, measures anxiety and depression.
Measured: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in ISI
Insomnia Severity Index. Self-administered, measures insomnia and sleeping problems
Measured: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in SSES6
Stanford Self-Efficacy for Managing Chronic Disease. Self-administered, measures self efficacy in relation to a chronic disease
Measured: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2015 (estimated)
- Study startDec 2015
- Primary completionMar 2017
- Study completionMar 2017
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 Parkinson 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 77 participants (actual)
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
- NCT02627885
- Sponsor's protocol ID
- 2015/1938-31/4
- Acronym
- Patrik
- Status last verified
- Jan 2020
- First submitted
- 9 Dec 2015
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kraepelien M, Schibbye R, Mansson K, Sundstrom C, Riggare S, Andersson G, Lindefors N, Svenningsson P, Kaldo V. Individually Tailored Internet-Based Cognitive-Behavioral Therapy for Daily Functioning in Patients with Parkinson's Disease: A Randomized Controlled Trial. J Parkinsons Dis. 2020;10(2):653-664. doi: 10.3233/JPD-191894.
PubMed 32176657
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internet-based Cognitive Behavioral Therapy to Increase Function and Quality of Life for Patients With Parkinsons Disease
- ClinicalTrials.gov ID
- NCT02627885
- Acronym / sponsor ID
- Patrik / 2015/1938-31/4
- Conditions
- Parkinson Disease
- Keywords
- internet treatment, cognitive behavioral therapy, level of functioning, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Region Stockholm
- Study start
- Dec 2015
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 11 Dec 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 aim of the study is to investigate if an Internet-based psychological treatment based on principles from Cognitive Behavioral Therapy can increase function and quality of life for patients with Parkinson disease.
Detailed description
The Internet-based Cognitive Behavioral Therapy (ICBT) will be given as an adjunct to the Standard Medical Treatment. ICBT will be compared to Standard Medical Treatment alone (SMT).
A secondary aim is make a preliminary evaluation of the ICBT-program with less and less active therapist support. It is hypothesized that both active treatments will be superior to SMT in improving quality of life and functioning and that ICBT with full therapist support will be superior to ICBT with lower level of therapist support.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ICBT | Active comparator | Behavioral: Internet-based CBTInternet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment |
| SMT | Other | Other: SMTStandard Medical Treatment for Parkinsons Disease only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosed Parkinson disease
- WSAS score of over 17
- Access to a internet connected device and a mobile phone capable of receiving SMS
Key exclusion criteria (7 listed)
- Substance or alcohol abuse
- Psychotic Disorder or Bipolar disorder
- Other psychiatric disorder that requires immediate attention or hinders the offered ICBT treatment
- Practical obstacles such as difficulties using the technology required to participate in the study, not having the time to actively wok with the treatment, or having symptoms from Parkinson to severe to be able to actively participate in the study
- High suicide risk, defined as:
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 |
|---|---|---|
| Internet-based CBTThrough the use of CBT material at an Internet-platform, we aim for behavioral changes in the subjects to improve everyday level of functioning and quality of life. | Behavioural | ICBT |
| SMTStandard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions | Other | SMT |
Primary outcome
Change (from baseline) in WSAS
Time frame: Baseline, nine weekly measure while in treatment, then the primary endpoint is after 10 weeks of treatment (Post), and there will also be up to two follow-up (FU) measures within 3 years from treatment completion
The Work and Social Adjustment Scale. Self-administered, measures impairment in functioning
8 secondary outcomes
Change (from baseline) in IPAQ
Time frame: Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in SVAQ
Time frame: Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in WHODAS-2
Time frame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in PDQ-8
Time frame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in BBQ
Time frame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in HADS
Time frame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in ISI
Time frame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Change (from baseline) in SSES6
Time frame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
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 7 Jan 2020.
- Derived from this study: PubMed 32176657Kraepelien M, Schibbye R, Mansson K, Sundstrom C, Riggare S, Andersson G, Lindefors N, Svenningsson P, Kaldo V. Individually Tailored Internet-Based Cognitive-Behavioral Therapy for Daily Functioning in Patients with Parkinson's Disease: A Randomized Controlled Trial. J Parkinsons Dis. 2020;10(2):653-664. doi: 10.3233/JPD-191894.
- Individual participant dataSharing planned: Undecided
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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 study testing Internet-based CBT and SMT in people with Parkinson Disease, 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 3 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 7 Jan 2020. 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.
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 WSAS (time frame: Baseline, nine weekly measure while in treatment, then the primary endpoint is after 10 weeks of treatment (Post), and there will also be up to two follow-up (FU) measures within 3 years from treatment completion). 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 NCT02627885, 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 7 Jan 2020.