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

Study Overview
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Brief Summary
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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.

Official Title
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Internet-based CBT for Depression and Anxiety in Parkinson's Disease: a Pilot Study and Randomized Controlled Trial

Conditions
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Parkinson's Disease, Depression, Anxiety, Insomnia

Intervention / Treatment
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* Behavioral: ICBT
* Behavioral: ICONTROL


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ICBT<br>Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation | Behavioral: ICBT<br>* 12 weeks of Internet-based Cognitive Behavioral Therapy with a focus on behavioral activation<br>|
| Active Comparator: ICONTROL<br>Internet-based treatment with a focus on relaxation training | Behavioral: ICONTROL<br>* 12 weeks of Internet-based treatment with a focus on relaxation training<br>|
| No Intervention: SMT<br>Standard Medical Treatment while being on the waitlist for randomization to any of the active treatments | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (from baseline) in HADS | Hospital Anxiety and Depression Scale - self rating, to measure anxiety and depression | 12 weeks (Post), 3 and 6 months (FU) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change (from baseline) in MADRS-S | Montgomery and Asberg Depressions Rating Scale - Self report, to measure level of depression | 12 weeks (Post), 3 and 6 months (FU) | 
| Change (from baseline) in ISI | Insomnia Severity Index - self-report, to measure insomnia symptoms | 12 weeks (Post), 3 and 6 months (FU) | 
| Change (from baseline) in PDQ-8 | The Parkinson's Disease Questionnaire-8, to measure various health aspects specific for PD patients | 12 weeks (Post), 3 and 6 months (FU) | 
| Change (from baseline) in EQ-5D | EQ-5D, to measure general health and quality of life | 12 weeks (Post), 3 and 6 months (FU) | 
| Change (from baseline) in SDS | Sheehan Disability Scale, to measure everyday level of functioning | 12 weeks (Post), 3 and 6 months (FU) | 
| Change (from baseline) in NMSQuest | Non-Motor Symptoms Questionnaire, to measure the non-motor symptoms in PD | 12 weeks (Post), 3 and 6 months (FU) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Self-help treatment, Internet treatment, Cognitive Behavioral Therapy, Internet-based Cognitive Behavioral Therapy