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Completed

NCT Number: NCT02627885

Internet-CBT for 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.

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Stockholm, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Internet-based CBT

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

Other

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

Primary outcomes

  1. Change (from baseline) in WSAS

    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

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

Secondary outcomes

  1. Change (from baseline) in IPAQ

    Time frame: Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures

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

  2. Change (from baseline) in SVAQ

    Time frame: Baseline, 5 weeks (Mid) 10 weeks (Post) and up to 2 (FU) measures

    Swedish Valued Activity Questionnaire. Self-administered, measures valued activities

  3. Change (from baseline) in WHODAS-2

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

    World Health Organization Disability Assessment Schedule 2 (12-item). Self-administered, measures disability

  4. Change (from baseline) in PDQ-8

    Time frame: 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

  5. Change (from baseline) in BBQ

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

    Brunnsviken Brief Quality of life scale. Self-administered, measures quality of life

  6. Change (from baseline) in HADS

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

    The Hospital Anxiety and Depression Scale. Self-administered, measures anxiety and depression.

  7. Change (from baseline) in ISI

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

    Insomnia Severity Index. Self-administered, measures insomnia and sleeping problems

  8. Change (from baseline) in SSES6

    Time frame: 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

Other outcomes

  1. Adverse Events (self-rated)

    Time frame: 5 weeks (Mid) and 10 weeks (Post)

  2. Adverse Events (therapist-rated)

    Time frame: 5 weeks (Mid) and 10 weeks (Post)

    Therapist use data from treatment to rate occurrences of Adverse events

  3. Adverse Events (interviewer-rated)

    Time frame: 10 weeks (Post)

    Blind assessor asks about Adverse Events during whole treatment

  4. Client Satisfaction

    Time frame: 10 weeks (Post)

    Client Satisfaction Questionnaire-8

  5. Clinical Global Impression - Severity scale

    Time frame: 10 weeks (Post)

  6. Clinical Global Impression - Improvement scale

    Time frame: 10 weeks (Post)

  7. Use of other treatments

    Time frame: 10 weeks (Post)

    Use of other treatments during treatment period, self-rated

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

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

Acronym: Patrik

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Dec 11, 2015
Registry last updated
Jan 7, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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