Internet-CBT for Parkinsons Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Internet-based Cognitive Behavioral Therapy to Increase Function and Quality of Life for Patients With Parkinsons Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Behavioral: Internet-based CBT
* Other: SMT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed Parkinson disease WSAS score of over 17 Access to a internet connected device and a mobile phone capable of receiving SMS Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ICBT<br>Internet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment | Behavioral: Internet-based CBT<br>* 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.<br>|
| Other: SMT<br>Standard Medical Treatment for Parkinsons Disease only | Other: SMT<br>* Standard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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internet treatment, cognitive behavioral therapy, level of functioning, quality of life