Internet-CBT for Parkinsons Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-31

Study Completion Date

2017-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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ICBT

Internet-based CBT for Parkinsons Disease with therapist contact added to standard medical treatment

Group Type ACTIVE_COMPARATOR

Internet-based CBT

Intervention Type BEHAVIORAL

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.

SMT

Standard Medical Treatment for Parkinsons Disease only

Group Type OTHER

SMT

Intervention Type OTHER

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

Interventions

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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.

Intervention Type BEHAVIORAL

SMT

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No