Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Parkinson's Disease
- Sponsor
- Karolinska Institutet
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Change (from baseline) in HADS
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Viktor Kaldo
Principal Investigator
Karolinska Institutet
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
Outcomes
Primary Outcomes
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
- Change (from baseline) in MADRS-S(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in ISI(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in PDQ-8(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in NMSQuest(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in EQ-5D(12 weeks (Post), 3 and 6 months (FU))
- Change (from baseline) in SDS(12 weeks (Post), 3 and 6 months (FU))