Internet-CBT for Parkinsons Disease

Karolinska Institutet77 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Parkinson Disease

Interventions

Internet-based CBTBEHAVIORAL

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.

SMTOTHER

Standard Medical Treatment includes pharmacological management and other typical medical interventions for the patient group but no behavioural interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Stockholm, Sweden

Outcomes

Primary Outcomes

Change (from baseline) in WSAS

The Work and Social Adjustment Scale. Self-administered, measures impairment in functioning

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

Secondary Outcomes

Change (from baseline) in IPAQ

International Physical Activity Questionnaire. Self-administered, measures physical activity

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Baseline, 10 weeks (Post) and up to 2 (FU) measures

Change (from baseline) in HADS

Data from ClinicalTrials.gov

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