Online Cognitive Behavioral Therapy for Depressive Symptoms in Parkinson's Disease

Study Overview
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Brief Summary
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More than 1 million people in Europe suffer from Parkinson's disease (PD), a brain disorder manifesting with a motor syndrome and several non-motor features. Neuropsychiatric symptoms, like anxiety and depression, are common in patients with PD, and has profound effects on quality of life and activities of daily living of the patient, and caregiver burden. Cognitive behavioral therapy (CBT) has proven efficient for depressive symptoms, but treatment availability to the general patient with PD is low. Thus, there is an urgent need for individualized remote approaches that can be of benefit to patients on a national scale. This study is a remote, randomized delayed start trial of the effectiveness of videoconference based cognitive behavioral therapy (eCBT) for PD patients with depressive symptoms. N=120 participants with PD and depressive symptoms will be recruited from neurological clinics across four health regions in Norway and self-reference, and randomized into two arms: (A) immediate eCBT with concurrent with TAU and (B) a delayed start (14 weeks) of eCBT with TAU alone. Patients will be assessed at baseline before allocation to treatment, with followed up evaluations 14, 28 and 42 weeks after baseline. The trial is designed as a state-of-the-art remote clinical trial, that can be easily implemented existing health services, resulting in a rapid implementation and improvement of treatment for patients with PD, and potentially large translational value to other brain disorders.

Detailed Description
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We will conduct a remote, randomized controlled trial with delayed start, in order to: Assess the 14-week effectiveness of eCBT for depressive symptoms for patients with PD. Assess long-term outcomes, and predictors of long-term outcomes, of eCBT for depressive symptoms in PD. Explore the impact and clinical correlates of working alliance in eCBT in patients with PD. For the first aim, we hypothesize that: i. 10 week eCBT will reduce the self-reported severity of depressive symptoms in patients with PD after 14 weeks, as compared to patients in a delayed start group, receiving treatment as usual (TAU). ii. 10 week eCBT will reduce the observed severity of depressive symptoms in patients with PD after 14 weeks, as compared to patients in a delayed start group, receiving TAU. i. 10 week eCBT will improve self-reported health related quality of life measured with The 8-item PD Questionnaire after 14 weeks, as compared to patient in a control group receiving TAU. For the second aim, we hypothesize: ii. Participants with 42 week follow up has lasting effects of eCBT, when compared to participants with 28 week follow up. iii. Long-term treatment response from eCBT for depressive symptoms, is predicted by the level of comorbid symptoms of anxiety and impulse control disorders at baseline. iv. Long-term treatment response from eCBT for depressive symptoms, is predicted by the level of comorbid symptoms of anxiety and impulse control disorders at the time of treatment completion. For the third aim, we hypothesize: i. The interrater agreement between patients and CBT therapist on working alliance will be a significant predictor of the acceptability of eCBT, as defined by patient reported experience measures.

Official Title
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A Decentralized Trial of Individual Video-assisted Cognitive Behavioural Therapy for Depressive Disorder in Parkinson's Disease.

Conditions
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Parkinson Disease, Depressive Symptoms, Anxiety

Intervention / Treatment
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* Behavioral: Online cognitive behavioral therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed written electronic consent; Confirmed PD clinical diagnosis based on self-report; A verified diagnosis of depression, according to previously published criteria; Age 35 to 85 years; Stable medication and mental health regiment (including antidepressants ≥ 6 weeks); Internet access from a computer or tablet. Exclusion Criteria: Cognitive impairment as defined by Montreal Cognitive Assessment (MoCA) Blind version scores of <18; Suicidal thoughts with plan and intent (clinical interview); Medically unstable; Currently receiving psychotherapeutic treatment; History of bipolar or psychotic disorders; Does not speak Norwegian; A history with neurosurgery (like deep brain stimulation); No familiarity and/or access to a computer or tablet with camera, or internet access.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 85 Years

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: Crossover Assignment
Interventional Model Description: This study is a online, randomized delayed start trial of the effectiveness of e-CBT for PD patients with depressive symptoms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate eCBT with concurrent TAU<br>Those randomized into the this group will get immediate e-CBT with TAU. | Behavioral: Online cognitive behavioral therapy<br>* The e-CBT treatment manual is an adjusted version of a previously published treatment manuals for neuropsychiatric symptoms in PD, which is tailored to the preferences and needs for each participant. This manual encompass both modules from manuals for depression in PD and anxiety in PD. Individualization is ensures by including several interventions modules in the manual, wherein 5 sessions are considered core modules, and four modules that can be offered depending on the patients individual needs. The participant may include partners or caregivers. The treatment is schedules to be completed within 13 weeks, with maximum ten sessions during this period. Following each e-CBT session, the participant will be asked to complete a short survey evaluating the acceptability and relevance of the session, and evaluate the therapeutic alliance.<br>|
| No Intervention: Delayed eCBT with concurrent TAU<br>Those randomized to the delayed arm of the study, will receive TAU and wait 14 weeks before receiving the intervention. TAU will include ongoing review by the patient's primary care physician, neurologist and PD nurse. TAU does not preclude clinically indicated adjustments to medication or specialist referrals but physicians are asked to keep medication constant if possible. For patients with PD ordinary treatment includes a multitude of interventions, including pharmacological treatment, speech therapy and physical therapy. Pharmacological interventions include the use of dopaminergic treatments, including levodopa and dopamine agonist use, with adjunct use of monoamine oxidase B-inhibitors. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Clinical Global Impression scale (CGI) score | A clinical-rated measure of general symptom severity of neuropsychiatric symptoms. | Baseline (BL) to 14 weeks | 
| Change in the Hospital Anxiety and Depression Scale (HADS), score | HADS is a commonly used self-report 14-item scale for the assessment of anxiety and depression in PD. | Baseline (BL) to 14 weeks | 
| Change in the 8-item PD Questionnaire | The 8-item version of the Parkinson's Disease Questionnaire (PDQ-8) is a shortened version of the 39-item Parkinson's Disease Questionnaire (PDQ-39). It was developed to reduce the respondent burden and increase convenience for use among persons with Parkinson's Disease in clinical settings. | Baseline (BL) to 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Automatic Thoughts Questionnaire-30- Negative (ATQ-30-N) score | is a 30-item self-report measure of the frequency of automatic negative thoughts associated with depression and anxiety. | Baseline, 14, 28 and 42 weeks | 
| Change in the The Behavioural Activation for Depression Scale (BADS) score | BADS is a 25-item self-report measure developed to measure the changes in activation and avoidance over the course of treatment of depression. | Baseline, 14, 28 and 42 weeks | 
| Change in The 39-item PD Questionnaire (PDQ-8) score | The PDQ-8 is a brief, valid and reliable patient reported outcome measure instrument to assess HRQoL in patients with PD with good concordant validity to generic HRQoL-scales. | Baseline, 14, 28 and 42 weeks | 
| The Negative Effects Questionnaire (NEQ) | NEQ is a 20 item self-report questionnaire measuring adverse and unwanted effects for psychological treatments. | 14, 28 and 42 weeks | 
| Change in the Parkinson Anxiety Scale (PAS) score | PAS is a 12-item self-report questionnaire measuring anxiety symptoms in patients with PD. | Baseline, 14, 28 and 42 weeks | 
| Patient reported experience measure (PREM): | Participants experiences will be assessed with a six item questionnaire, scored on a visual analogue scale anchored with ''not at all'' to ''very much''. The questionnaire is comprised of six question indices: (1) interesting, (2) easy to understand, (3) useful, (4) extent to which the intervention provided novel information, (5) satisfaction, and (6) relevance. | 14, 28 and 42 weeks | 
| Patient version of the Working Alliance Inventory (WAI): | WAI is a 12-item questionnaire evaluating the working alliance between patients and the CBT-therapist. | 14, 28 and 42 weeks | 
| Change in the Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire Rating scale (QUIP-RS) score | QUIP-RS is a quick assessment of the severity of impulsive and compulsive behaviors in Parkinsons disease. | Baseline, 14, 28 and 42 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinsons disease, Neuropsychiatry, Cognitive behavioral therapy