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| Name | Class |
|---|---|
| Region Stockholm | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ICBT | Active Comparator | Internet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment |
|
| SMT | Other | Standard Medical Treatment for Parkinsons Disease only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Internet-based CBT | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change (from baseline) in WSAS | The Work and Social Adjustment Scale. Self-administered, measures impairment in functioning | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change (from baseline) in IPAQ | International Physical Activity Questionnaire. Self-administered, measures physical activity | Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures |
| Change (from baseline) in SVAQ |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events (self-rated) | 5 weeks (Mid) and 10 weeks (Post) | |
| Adverse Events (therapist-rated) | Therapist use data from treatment to rate occurrences of Adverse events | 5 weeks (Mid) and 10 weeks (Post) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Viktor Kaldo, Ph. D | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden | Stockholm | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32176657 | Derived | 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. |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| SMT | Other | Standard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions |
|
Swedish Valued Activity Questionnaire. Self-administered, measures valued activities
| 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 | 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 | 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 | 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. | 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 | 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 | Baseline, 10 weeks (Post) and up to 2 (FU) measures |
| Adverse Events (interviewer-rated) | Blind assessor asks about Adverse Events during whole treatment | 10 weeks (Post) |
| Client Satisfaction | Client Satisfaction Questionnaire-8 | 10 weeks (Post) |
| Clinical Global Impression - Severity scale | 10 weeks (Post) |
| Clinical Global Impression - Improvement scale | 10 weeks (Post) |
| Use of other treatments | Use of other treatments during treatment period, self-rated | 10 weeks (Post) |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |