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

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ClinicalTrials.gov Identifier: NCT01545414
Recruitment Status : Completed
First Posted : March 6, 2012
Last Update Posted : February 13, 2015
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Depression Anxiety Insomnia Behavioral: ICBT Behavioral: ICONTROL Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial
Study Start Date : February 2012
Primary Completion Date : August 2013
Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: ICBT
Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
Behavioral: ICBT
12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
Active Comparator: ICONTROL
Internet-based treatment with a focus on relaxation training
Behavioral: ICONTROL
12 weeks of Internet-based treatment with a focus on relaxation training
No Intervention: SMT
Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments

Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545414

Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
Stockholm, Sweden
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
Principal Investigator: Viktor Kaldo, Ph.D. Karolinska Institutet
More Information

Additional Information:
Responsible Party: Viktor Kaldo, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01545414     History of Changes
Other Study ID Numbers: ICBT Parkinson
First Posted: March 6, 2012    Key Record Dates
Last Update Posted: February 13, 2015
Last Verified: February 2015

Keywords provided by Viktor Kaldo, Karolinska Institutet:
Self-help treatment
Internet treatment
Cognitive Behavioral Therapy
Internet-based Cognitive Behavioral Therapy

Additional relevant MeSH terms:
Depressive Disorder
Parkinson Disease
Anxiety Disorders
Behavioral Symptoms
Mood Disorders
Mental Disorders
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases