Anxiety, Depression, Insomnia, Parkinson's Disease
Conditions
Keywords
Self-help treatment, Internet treatment, Cognitive Behavioral Therapy, Internet-based Cognitive Behavioral Therapy
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.
Interventions
BEHAVIORALICBT
12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation
BEHAVIORALICONTROL
12 weeks of Internet-based treatment with a focus on relaxation training
Sponsors
Region Stockholm
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change (from baseline) in HADS | 12 weeks (Post), 3 and 6 months (FU) | Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change (from baseline) in ISI | 12 weeks (Post), 3 and 6 months (FU) | Insomnia Severity Index - self-report, to measure insomnia symptoms |
| Change (from baseline) in PDQ-8 | 12 weeks (Post), 3 and 6 months (FU) | The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients |
| Change (from baseline) in MADRS-S | 12 weeks (Post), 3 and 6 months (FU) | Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression |
| Change (from baseline) in SDS | 12 weeks (Post), 3 and 6 months (FU) | Sheehan Disability Scale, to measure everyday level of functioning |
| Change (from baseline) in NMSQuest | 12 weeks (Post), 3 and 6 months (FU) | Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD |
| Change (from baseline) in EQ-5D | 12 weeks (Post), 3 and 6 months (FU) | EQ-5D, to measure general health and quality of life |
Countries
Sweden
Outcome results
None listed