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Completed

NCT Number: NCT01545414

Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease

The purpose of this project is to develop and evaluate Internet-based Cognitive Behavioral Therapy (ICBT) for Parkinson's Disease (PD) patients with concurrent depression or anxiety symptoms. All treatment in this project is given as an adjunct to Standard Medical Treatment (SMT). ICBT will be compared to an Internet-based active control treatment (ICONTROL) and to SMT alone. It is hypothesized that both active treatments will be superior to SMT, and that ICBT will be superior to ICONTROL, in reducing symptoms of depression and anxiety.

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Key information

Conditions

Parkinson's Disease Anxiety Anxiety Disorders Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Depression Dyssomnias Insomnia Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinson Disease Parkinsonian Disorders Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders Synucleinopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO

Stockholm, Sweden

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Clinical diagnosis of Parkinson's Disease
  • At least mild to moderate depression or anxiety defined as HADS-A or HADS-D > 7

Exclusion criteria

  • Has a high alcohol or drug use assessed by the AUDIT / DUDIT and assessment interview
  • Somatic or psychiatric problems that are directly contraindicated or seriously hamper the implementation of the treatment (eg, psychotic disorders or bipolar disorder)
  • Difficulties that hamper the use of a computer
  • The patient states difficulties in finding enough time for treatment
  • Too low cognitive functioning defined as MoCA < 24
  • Too severe depression, defined as MADRS-S over 30
  • Too high suicidal risk defined as more than 4 points on the MADRS-S question 9 or according to the structured assessment interview

Treatment and study plan

ICBT

Behavioral

12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation

ICONTROL

Behavioral

12 weeks of Internet-based treatment with a focus on relaxation training

Primary outcomes

  1. Change (from baseline) in HADS

    Time frame: 12 weeks (Post), 3 and 6 months (FU)

    Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression

Secondary outcomes

  1. Change (from baseline) in MADRS-S

    Time frame: 12 weeks (Post), 3 and 6 months (FU)

    Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression

  2. Change (from baseline) in ISI

    Time frame: 12 weeks (Post), 3 and 6 months (FU)

    Insomnia Severity Index - self-report, to measure insomnia symptoms

  3. Change (from baseline) in PDQ-8

    Time frame: 12 weeks (Post), 3 and 6 months (FU)

    The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients

  4. Change (from baseline) in EQ-5D

    Time frame: 12 weeks (Post), 3 and 6 months (FU)

    EQ-5D, to measure general health and quality of life

  5. Change (from baseline) in SDS

    Time frame: 12 weeks (Post), 3 and 6 months (FU)

    Sheehan Disability Scale, to measure everyday level of functioning

  6. Change (from baseline) in NMSQuest

    Time frame: 12 weeks (Post), 3 and 6 months (FU)

    Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Region Stockholm

Registry information

Official study title

Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 6, 2012
Registry last updated
Feb 13, 2015

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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