Internet-CBT (Cognitive Behavioral Therapy) for Depression and Anxiety in Parkinsons Disease
This study is currently recruiting participants.
Verified March 2012 by Karolinska Institutet
Sponsor:
Karolinska Institutet
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: March 5, 2012
Last verified: March 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545414
Contacts
| Contact: Viktor Kaldo, Ph.D. | +46 709 77 55 99 | viktor.kaldo@ki.se |
| Contact: Per Svenningsson, Ph.D. M.D. | per.svenningsson@ki.se |
Locations
| Sweden | |
| Internetpsykiatrienehten (Internet Psychiatry Unit), Psykiatri Sydväst, SLSO | Recruiting |
| Stockholm, Sweden | |
| Contact: Viktor Kaldo, Ph.D. +46 709 77 55 99 viktor.kaldo@ki.se | |
| Principal Investigator: Viktor Kaldo, Ph.D. | |
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: | March 5, 2012 |
| 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 May 23, 2013