Back to resultsInternet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease
Primary Purpose
Parkinson's Disease, Depression, Anxiety
Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
ICBT
ICONTROL
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring Self-help treatment, Internet treatment, Cognitive Behavioral Therapy, Internet-based Cognitive Behavioral Therapy
Eligibility 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
Sites / Locations
- Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
No Intervention
Arm Label
ICBT
ICONTROL
SMT
Arm Description
Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
Internet-based treatment with a focus on relaxation training
Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments
Outcomes
Primary Outcome Measures
Change (from baseline) in HADS
Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression
Secondary Outcome Measures
Change (from baseline) in MADRS-S
Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression
Change (from baseline) in ISI
Insomnia Severity Index - self-report, to measure insomnia symptoms
Change (from baseline) in PDQ-8
The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients
Change (from baseline) in EQ-5D
EQ-5D, to measure general health and quality of life
Change (from baseline) in SDS
Sheehan Disability Scale, to measure everyday level of functioning
Change (from baseline) in NMSQuest
Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD
Full Information
NCT ID
NCT01545414
First Posted
March 1, 2012
Last Updated
February 12, 2015
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
1. Study Identification
Unique Protocol Identification Number
NCT01545414
Brief Title
Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease
Official Title
Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2015
Overall Recruitment Status
Completed
Study Start Date
February 2012 (undefined)
Primary Completion Date
August 2013 (Actual)
Study Completion Date
August 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease, Depression, Anxiety, Insomnia
Keywords
Self-help treatment, Internet treatment, Cognitive Behavioral Therapy, Internet-based Cognitive Behavioral Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ICBT
Arm Type
Experimental
Arm Description
Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
Arm Title
ICONTROL
Arm Type
Active Comparator
Arm Description
Internet-based treatment with a focus on relaxation training
Arm Title
SMT
Arm Type
No Intervention
Arm Description
Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments
Intervention Type
Behavioral
Intervention Name(s)
ICBT
Intervention Description
12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
Intervention Type
Behavioral
Intervention Name(s)
ICONTROL
Intervention Description
12 weeks of Internet-based treatment with a focus on relaxation training
Primary Outcome Measure Information:
Title
Change (from baseline) in HADS
Description
Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression
Time Frame
12 weeks (Post), 3 and 6 months (FU)
Secondary Outcome Measure Information:
Title
Change (from baseline) in MADRS-S
Description
Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression
Time Frame
12 weeks (Post), 3 and 6 months (FU)
Title
Change (from baseline) in ISI
Description
Insomnia Severity Index - self-report, to measure insomnia symptoms
Time Frame
12 weeks (Post), 3 and 6 months (FU)
Title
Change (from baseline) in PDQ-8
Description
The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients
Time Frame
12 weeks (Post), 3 and 6 months (FU)
Title
Change (from baseline) in EQ-5D
Description
EQ-5D, to measure general health and quality of life
Time Frame
12 weeks (Post), 3 and 6 months (FU)
Title
Change (from baseline) in SDS
Description
Sheehan Disability Scale, to measure everyday level of functioning
Time Frame
12 weeks (Post), 3 and 6 months (FU)
Title
Change (from baseline) in NMSQuest
Description
Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD
Time Frame
12 weeks (Post), 3 and 6 months (FU)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Viktor Kaldo, Ph.D.
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO
City
Stockholm
Country
Sweden
12. IPD Sharing Statement
Links:
URL
http://www.internetpsykiatri.se
Description
The public page of the Internet-CBT treatment platform
Learn more about this trial
Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease
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