Internet-CBT for Parkinsons Disease

Not Applicable

Completed

• Conditions: Parkinson Disease
• Interventions: Other: SMT; Behavioral: Internet-based CBT

• Registration Number: NCT02627885
• Lead Sponsor: Karolinska Institutet

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-09
• Study First Submitted QC: 2015-12-10
• Study First Posted: 2015-12-11
• Primary Completion: 2017-03
• Study Completion: 2017-03
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-05
• Last Update Posted: 2020-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 77

Inclusion Criteria

• Diagnosed Parkinson disease
• WSAS score of over 17
• Access to a internet connected device and a mobile phone capable of receiving SMS

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SMT	SMT	Standard Medical Treatment for Parkinsons Disease only
ICBT	Internet-based CBT	Internet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 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 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 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 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
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 HADS	Baseline, 10 weeks (Post) and up to 2 (FU) measures	The Hospital Anxiety and Depression Scale. Self-administered, measures anxiety and depression.

Trial Locations

Locations (1)

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO Stockholm, Sweden; 🇸🇪 Stockholm, Sweden