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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Parkinson Disease; Anxiety; Depressive Symptoms
• Intervention / Treatment: Behavioral: Online cognitive behavioral therapy

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.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksander Erga, PhD; Phone Number: +4751515218; Email: aleksander.hagen.erga@sus.no
• Study Contact Backup: Name: Veslemøy Frantzen, MA; Phone Number: +4751515218; Email: veslemoy.hamre.frantzen@sus.no

Study Locations

• Norway
  • Stavanger, Norway, 4068
    • Recruiting
    • Stavanger University Hospital, Norwegian Centre for Movement Disorders
    • Contact: Aleksander H Erga, PhD; Email: aleksander.hagen.erga@sus.no
    • Contact: Veslemøy H Frantzen, Ms; Email: veslemoy.hamre.frantzen@sus.no

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Immediate eCBT with concurrent TAU; Those randomized into the this group will get immediate e-CBT with TAU.	Behavioral: Online 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.
No Intervention: Delayed eCBT with concurrent TAU; 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?

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

Collaborators and Investigators

• Sponsor: Helse Stavanger HF
• Investigators: Principal Investigator: Aleksander H Erga, PhD, Norwegian Centre for Movement Disorders, Stavanger University Hospital

Publications and helpful links

General Publications

• Erga AH, Alves G, Leentjens AFG. The ePark study protocol: A decentralized trial of individual video-assisted cognitive behavioural therapy for depressive disorder in Parkinson's disease. Contemp Clin Trials Commun. 2023 Feb 3;32:101080. doi: 10.1016/j.conctc.2023.101080. eCollection 2023 Apr. No abstract available. Erratum In: Contemp Clin Trials Commun. 2023 Aug 29;35:101205.
• Erga AH, Alves G, Leentjens AFG. Corrigendum to "The ePark study protocol: A decentralized trial of individual video-assisted cognitive behavioural therapy for depressive disorder in Parkinson's disease" [Contemp. Clinic. Trials Commun. 32 (2023) 101080]. Contemp Clin Trials Commun. 2023 Aug 29;35:101205. doi: 10.1016/j.conctc.2023.101205. eCollection 2023 Oct.

Helpful Links

• Study website (Norwegian)

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: September 20, 2022
• First Submitted That Met QC Criteria: October 18, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): November 28, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Cognitive behavioral therapy; Parkinsons disease; Neuropsychiatry
• Additional Relevant MeSH Terms: Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Depression; Parkinson Disease
• Other Study ID Numbers: 3414-3414

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No