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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Viktor Kaldo, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01545414
First received: March 1, 2012
Last updated: November 7, 2013
Last verified: November 2013
  Purpose

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 Intervention Phase
Parkinson's Disease
Depression
Anxiety
Insomnia
Behavioral: ICBT
Behavioral: ICONTROL
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Change (from baseline) in HADS [ Time Frame: 12 weeks (Post), 3 and 6 months (FU) ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression


Secondary Outcome Measures:
  • Change (from baseline) in MADRS-S [ Time Frame: 12 weeks (Post), 3 and 6 months (FU) ] [ Designated as safety issue: No ]
    Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression

  • Change (from baseline) in ISI [ Time Frame: 12 weeks (Post), 3 and 6 months (FU) ] [ Designated as safety issue: No ]
    Insomnia Severity Index - self-report, to measure insomnia symptoms

  • Change (from baseline) in PDQ-8 [ Time Frame: 12 weeks (Post), 3 and 6 months (FU) ] [ Designated as safety issue: No ]
    The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients

  • Change (from baseline) in EQ-5D [ Time Frame: 12 weeks (Post), 3 and 6 months (FU) ] [ Designated as safety issue: No ]
    EQ-5D, to measure general health and quality of life

  • Change (from baseline) in SDS [ Time Frame: 12 weeks (Post), 3 and 6 months (FU) ] [ Designated as safety issue: No ]
    Sheehan Disability Scale, to measure everyday level of functioning

  • Change (from baseline) in NMSQuest [ Time Frame: 12 weeks (Post), 3 and 6 months (FU) ] [ Designated as safety issue: No ]
    Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD


Estimated Enrollment: 150
Study Start Date: February 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01545414

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

Additional Information:
No publications provided

Responsible Party: Viktor Kaldo, Principal Investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01545414     History of Changes
Other Study ID Numbers: ICBT Parkinson
Study First Received: March 1, 2012
Last Updated: November 7, 2013
Health Authority: Sweden: Regional Ethical Review Board

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

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

ClinicalTrials.gov processed this record on August 28, 2014