Clinical trial NCT02627885: Internet-CBT for Parkinsons Disease
Official title: Internet-based Cognitive Behavioral Therapy to Increase Function and Quality of Life for Patients With Parkinsons Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: internet treatment
cognitive behavioral therapy
level of functioning
quality of life
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2015-12-11
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change (from baseline) in WSAS
timeFrame: 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 outcomes:
measure: Change (from baseline) in IPAQ
timeFrame: Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
measure: Change (from baseline) in SVAQ
timeFrame: Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures
measure: Change (from baseline) in WHODAS-2
timeFrame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
measure: Change (from baseline) in PDQ-8
timeFrame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
measure: Change (from baseline) in BBQ
timeFrame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
measure: Change (from baseline) in HADS
timeFrame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
measure: Change (from baseline) in ISI
timeFrame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
measure: Change (from baseline) in SSES6
timeFrame: Baseline, 10 weeks (Post) and up to 2 (FU) measures
Other outcomes:
measure: Adverse Events (self-rated)
timeFrame: 5 weeks (Mid) and 10 weeks (Post)
measure: Adverse Events (therapist-rated)
timeFrame: 5 weeks (Mid) and 10 weeks (Post)
measure: Adverse Events (interviewer-rated)
timeFrame: 10 weeks (Post)
measure: Client Satisfaction
timeFrame: 10 weeks (Post)
measure: Clinical Global Impression - Severity scale
timeFrame: 10 weeks (Post)
measure: Clinical Global Impression - Improvement scale
timeFrame: 10 weeks (Post)
measure: Use of other treatments
timeFrame: 10 weeks (Post)
Locations:
city: Stockholm
country: Sweden
facility: Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden
Study officials:
affiliation: Karolinska Institutet
name: Viktor Kaldo, Ph. D
role: PRINCIPAL_INVESTIGATOR
References:
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.