Parkinson Disease
Conditions
Keywords
internet treatment, cognitive behavioral therapy, level of functioning, quality of life
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.
Interventions
BEHAVIORALInternet-based CBT
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.
OTHERSMT
Standard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (from baseline) in WSAS | 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
| Measure | Time frame | Description |
|---|---|---|
| Change (from baseline) in IPAQ | Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures | International Physical Activity Questionnaire. Self-administered, measures physical activity |
| Change (from baseline) in WHODAS-2 | Baseline, 10 weeks (Post) and up to 2 (FU) measures | World Health Organization Disability Assessment Schedule 2 (12-item). Self-administered, measures disability |
| Change (from baseline) in SVAQ | Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures | Swedish Valued Activity Questionnaire. Self-administered, measures valued activities |
| Change (from baseline) in PDQ-8 | Baseline, 10 weeks (Post) and up to 2 (FU) measures | Parkinson's Disease Questionnaire-8. Self-administered, measures functioning and well-being patients with Parkinsons disease |
| Change (from baseline) in BBQ | Baseline, 10 weeks (Post) and up to 2 (FU) measures | Brunnsviken Brief Quality of life scale. Self-administered, measures quality of life |
| Change (from baseline) in HADS | Baseline, 10 weeks (Post) and up to 2 (FU) measures | The Hospital Anxiety and Depression Scale. Self-administered, measures anxiety and depression. |
| Change (from baseline) in ISI | Baseline, 10 weeks (Post) and up to 2 (FU) measures | Insomnia Severity Index. Self-administered, measures insomnia and sleeping problems |
| Change (from baseline) in SSES6 | Baseline, 10 weeks (Post) and up to 2 (FU) measures | Stanford Self-Efficacy for Managing Chronic Disease. Self-administered, measures self efficacy in relation to a chronic disease |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events (interviewer-rated) | 10 weeks (Post) | Blind assessor asks about Adverse Events during whole treatment |
| Client Satisfaction | 10 weeks (Post) | Client Satisfaction Questionnaire-8 |
| Clinical Global Impression - Severity scale | 10 weeks (Post) | — |
| Clinical Global Impression - Improvement scale | 10 weeks (Post) | — |
| Use of other treatments | 10 weeks (Post) | Use of other treatments during treatment period, self-rated |
| Adverse Events (therapist-rated) | 5 weeks (Mid) and 10 weeks (Post) | Therapist use data from treatment to rate occurrences of Adverse events |
| Adverse Events (self-rated) | 5 weeks (Mid) and 10 weeks (Post) | — |
Countries
Sweden
Outcome results
None listed