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

Helse Stavanger HF

Status: Completed

Conditions: Depressive Symptoms; Parkinson Disease; Anxiety

Treatments: Behavioral: Online cognitive behavioral therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05585827

3414-3414

Details and patient eligibility

About

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.

Full 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.

Enrollment: 11 patients

Sex: All

Ages: 35 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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11 participants in 2 patient groups

Immediate eCBT with concurrent TAU

Experimental group

Description:

Those randomized into the this group will get immediate e-CBT with TAU.

Treatment:

Behavioral: Online cognitive behavioral therapy

Delayed eCBT with concurrent TAU

No Intervention group

Description:

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.