Internet-CBT for Parkinsons Disease (Patrik)
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Internet-based CBT
SMT
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring internet treatment, cognitive behavioral therapy, level of functioning, quality of life
Eligibility Criteria
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
Sites / Locations
- Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Other
Arm Label
ICBT
SMT
Arm Description
Internet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment
Standard Medical Treatment for Parkinsons Disease only
Outcomes
Primary Outcome Measures
Change (from baseline) in WSAS
The Work and Social Adjustment Scale. Self-administered, measures impairment in functioning
Secondary Outcome Measures
Change (from baseline) in IPAQ
International Physical Activity Questionnaire. Self-administered, measures physical activity
Change (from baseline) in SVAQ
Swedish Valued Activity Questionnaire. Self-administered, measures valued activities
Change (from baseline) in WHODAS-2
World Health Organization Disability Assessment Schedule 2 (12-item). Self-administered, measures disability
Change (from baseline) in PDQ-8
Parkinson's Disease Questionnaire-8. Self-administered, measures functioning and well-being patients with Parkinsons disease
Change (from baseline) in BBQ
Brunnsviken Brief Quality of life scale. Self-administered, measures quality of life
Change (from baseline) in HADS
The Hospital Anxiety and Depression Scale. Self-administered, measures anxiety and depression.
Change (from baseline) in ISI
Insomnia Severity Index. Self-administered, measures insomnia and sleeping problems
Change (from baseline) in SSES6
Stanford Self-Efficacy for Managing Chronic Disease. Self-administered, measures self efficacy in relation to a chronic disease
Full Information
NCT ID
NCT02627885
First Posted
December 9, 2015
Last Updated
January 5, 2020
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT02627885
Brief Title
Internet-CBT for Parkinsons Disease
Acronym
Patrik
Official Title
Internet-based Cognitive Behavioral Therapy to Increase Function and Quality of Life for Patients With Parkinsons Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
December 2015 (undefined)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
internet treatment, cognitive behavioral therapy, level of functioning, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
77 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ICBT
Arm Type
Active Comparator
Arm Description
Internet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment
Arm Title
SMT
Arm Type
Other
Arm Description
Standard Medical Treatment for Parkinsons Disease only
Intervention Type
Behavioral
Intervention Name(s)
Internet-based CBT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
SMT
Intervention Description
Standard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions
Primary Outcome Measure Information:
Title
Change (from baseline) in WSAS
Description
The Work and Social Adjustment Scale. Self-administered, measures impairment in functioning
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
Secondary Outcome Measure Information:
Title
Change (from baseline) in IPAQ
Description
International Physical Activity Questionnaire. Self-administered, measures physical activity
Time Frame
Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
Title
Change (from baseline) in SVAQ
Description
Swedish Valued Activity Questionnaire. Self-administered, measures valued activities
Time Frame
Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
Title
Change (from baseline) in WHODAS-2
Description
World Health Organization Disability Assessment Schedule 2 (12-item). Self-administered, measures disability
Time Frame
Baseline, 10 weeks (Post) and up to 2 (FU) measures
Title
Change (from baseline) in PDQ-8
Description
Parkinson's Disease Questionnaire-8. Self-administered, measures functioning and well-being patients with Parkinsons disease
Time Frame
Baseline, 10 weeks (Post) and up to 2 (FU) measures
Title
Change (from baseline) in BBQ
Description
Brunnsviken Brief Quality of life scale. Self-administered, measures quality of life
Time Frame
Baseline, 10 weeks (Post) and up to 2 (FU) measures
Title
Change (from baseline) in HADS
Description
The Hospital Anxiety and Depression Scale. Self-administered, measures anxiety and depression.
Time Frame
Baseline, 10 weeks (Post) and up to 2 (FU) measures
Title
Change (from baseline) in ISI
Description
Insomnia Severity Index. Self-administered, measures insomnia and sleeping problems
Time Frame
Baseline, 10 weeks (Post) and up to 2 (FU) measures
Title
Change (from baseline) in SSES6
Description
Stanford Self-Efficacy for Managing Chronic Disease. Self-administered, measures self efficacy in relation to a chronic disease
Time Frame
Baseline, 10 weeks (Post) and up to 2 (FU) measures
Other Pre-specified Outcome Measures:
Title
Adverse Events (self-rated)
Time Frame
5 weeks (Mid) and 10 weeks (Post)
Title
Adverse Events (therapist-rated)
Description
Therapist use data from treatment to rate occurrences of Adverse events
Time Frame
5 weeks (Mid) and 10 weeks (Post)
Title
Adverse Events (interviewer-rated)
Description
Blind assessor asks about Adverse Events during whole treatment
Time Frame
10 weeks (Post)
Title
Client Satisfaction
Description
Client Satisfaction Questionnaire-8
Time Frame
10 weeks (Post)
Title
Clinical Global Impression - Severity scale
Time Frame
10 weeks (Post)
Title
Clinical Global Impression - Improvement scale
Time Frame
10 weeks (Post)
Title
Use of other treatments
Description
Use of other treatments during treatment period, self-rated
Time Frame
10 weeks (Post)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktor Kaldo, Ph. D
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32176657
Citation
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.
Results Reference
derived
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Internet-CBT for Parkinsons Disease
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