Internet-CBT for Parkinsons Disease (Patrik)

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

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.

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Internet-based CBT; Other: SMT

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (self-rated)		5 weeks (Mid) and 10 weeks (Post)
Adverse Events (therapist-rated)	Therapist use data from treatment to rate occurrences of Adverse events	5 weeks (Mid) and 10 weeks (Post)
Adverse Events (interviewer-rated)	Blind assessor asks about Adverse Events during whole treatment	10 weeks (Post)
Client Satisfaction	Client Satisfaction Questionnaire-8	10 weeks (Post)
Clinical Global Impression - Severity scale		10 weeks (Post)
Clinical Global Impression - Improvement scale		10 weeks (Post)
Use of other treatments	Use of other treatments during treatment period, self-rated	10 weeks (Post)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm
• Investigators: Principal Investigator: Viktor Kaldo, Ph. D, Karolinska Institutet

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2015
• Primary Completion (Actual): March 1, 2017
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: December 9, 2015
• First Submitted That Met QC Criteria: December 10, 2015
• First Posted (Estimate): December 11, 2015

Study Record Updates

• Last Update Posted (Actual): January 7, 2020
• Last Update Submitted That Met QC Criteria: January 5, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: quality of life; cognitive behavioral therapy; internet treatment; level of functioning
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2015/1938-31/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED