Parkinson Disease, Depressive Symptoms, Anxiety
Conditions
Keywords
Parkinsons disease, Neuropsychiatry, Cognitive behavioral therapy
Brief summary
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
We will conduct a remote, randomized controlled trial with delayed start, in order to: 1. Assess the 14-week effectiveness of eCBT for depressive symptoms for patients with PD. 2. Assess long-term outcomes, and predictors of long-term outcomes, of eCBT for depressive symptoms in PD. 3. 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.
Interventions
BEHAVIORALOnline cognitive behavioral therapy
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.
Sponsors
Helse Stavanger HF
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
This study is a online, randomized delayed start trial of the effectiveness of e-CBT for PD patients with depressive symptoms.
Eligibility
Sex/Gender
ALL
Age
35 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in The Clinical Global Impression scale (CGI) score | Baseline (BL) to 14 weeks | A clinical-rated measure of general symptom severity of neuropsychiatric symptoms. |
| Change in the Hospital Anxiety and Depression Scale (HADS), score | Baseline (BL) to 14 weeks | HADS is a commonly used self-report 14-item scale for the assessment of anxiety and depression in PD. |
| Change in the 8-item PD Questionnaire | Baseline (BL) to 14 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Negative Effects Questionnaire (NEQ) | 14, 28 and 42 weeks | NEQ is a 20 item self-report questionnaire measuring adverse and unwanted effects for psychological treatments. |
| Change in the Parkinson Anxiety Scale (PAS) score | Baseline, 14, 28 and 42 weeks | PAS is a 12-item self-report questionnaire measuring anxiety symptoms in patients with PD. |
| Change in the Automatic Thoughts Questionnaire-30- Negative (ATQ-30-N) score | Baseline, 14, 28 and 42 weeks | is a 30-item self-report measure of the frequency of automatic negative thoughts associated with depression and anxiety. |
| Patient version of the Working Alliance Inventory (WAI): | 14, 28 and 42 weeks | WAI is a 12-item questionnaire evaluating the working alliance between patients and the CBT-therapist. |
| Change in the Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire Rating scale (QUIP-RS) score | Baseline, 14, 28 and 42 weeks | QUIP-RS is a quick assessment of the severity of impulsive and compulsive behaviors in Parkinsons disease. |
| Patient reported experience measure (PREM): | 14, 28 and 42 weeks | 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. |
| Change in the The Behavioural Activation for Depression Scale (BADS) score | Baseline, 14, 28 and 42 weeks | BADS is a 25-item self-report measure developed to measure the changes in activation and avoidance over the course of treatment of depression. |
| Change in The 39-item PD Questionnaire (PDQ-8) score | Baseline, 14, 28 and 42 weeks | 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. |
Countries
Norway
Outcome results
None listed