Internet-based Cognitive Behavioral Therapy to Increase Function and Quality of Life for Patients With Parkinsons Disease
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Parkinson Disease
- Sponsor
- Karolinska Institutet
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Change (from baseline) in WSAS
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Viktor Kaldo
Associate Professor (Docent)
Karolinska Institutet
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Change (from baseline) in PDQ-8(Baseline, 10 weeks (Post) and up to 2 (FU) measures)
- Change (from baseline) in BBQ(Baseline, 10 weeks (Post) and up to 2 (FU) measures)
- Change (from baseline) in IPAQ(Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures)
- Change (from baseline) in ISI(Baseline, 10 weeks (Post) and up to 2 (FU) measures)
- Change (from baseline) in SVAQ(Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures)
- Change (from baseline) in SSES6(Baseline, 10 weeks (Post) and up to 2 (FU) measures)
- Change (from baseline) in WHODAS-2(Baseline, 10 weeks (Post) and up to 2 (FU) measures)
- Change (from baseline) in HADS(Baseline, 10 weeks (Post) and up to 2 (FU) measures)