Clinical trial NCT05585827: Online Cognitive Behavioral Therapy for Depressive Symptoms in Parkinson's Disease
Official title: A Decentralized Trial of Individual Video-assisted Cognitive Behavioural Therapy for Depressive Disorder in Parkinson's Disease.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Depressive Symptoms
Anxiety
Keywords: Parkinsons disease
Neuropsychiatry
Cognitive behavioral therapy
Lead sponsor: Helse Stavanger HF
Sponsor class: OTHER_GOV
First posted: 2022-10-19
Enrollment: 11
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a online, randomized delayed start trial of the effectiveness of e-CBT for PD patients with depressive symptoms.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in The Clinical Global Impression scale (CGI) score
timeFrame: Baseline (BL) to 14 weeks
measure: Change in the Hospital Anxiety and Depression Scale (HADS), score
timeFrame: Baseline (BL) to 14 weeks
measure: Change in the 8-item PD Questionnaire
timeFrame: Baseline (BL) to 14 weeks
Secondary outcomes:
measure: Change in the Automatic Thoughts Questionnaire-30- Negative (ATQ-30-N) score
timeFrame: Baseline, 14, 28 and 42 weeks
measure: Change in the The Behavioural Activation for Depression Scale (BADS) score
timeFrame: Baseline, 14, 28 and 42 weeks
measure: Change in The 39-item PD Questionnaire (PDQ-8) score
timeFrame: Baseline, 14, 28 and 42 weeks
measure: The Negative Effects Questionnaire (NEQ)
timeFrame: 14, 28 and 42 weeks
measure: Change in the Parkinson Anxiety Scale (PAS) score
timeFrame: Baseline, 14, 28 and 42 weeks
measure: Patient reported experience measure (PREM):
timeFrame: 14, 28 and 42 weeks
measure: Patient version of the Working Alliance Inventory (WAI):
timeFrame: 14, 28 and 42 weeks
measure: Change in the Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire Rating scale (QUIP-RS) score
timeFrame: Baseline, 14, 28 and 42 weeks
Other outcomes:
Locations:
city: Stavanger
country: Norway
facility: Stavanger University Hospital, Norwegian Centre for Movement Disorders
Study officials:
affiliation: Norwegian Centre for Movement Disorders, Stavanger University Hospital
name: Aleksander H Erga, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.