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

Not Applicable

Completed

• Conditions: Depressive Symptoms; Parkinson Disease; Anxiety
• Interventions: Behavioral: Online cognitive behavioral therapy

• Registration Number: NCT05585827
• Lead Sponsor: Helse Stavanger HF

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.

Study Timeline

• Study First Submitted: 2022-09-20
• Study First Submitted QC: 2022-10-18
• Study First Posted: 2022-10-19
• Study Start: 2022-12-07
• Status Verified: 2024-11
• Primary Completion: 2024-11-27
• Study Completion: 2024-11-27
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Immediate eCBT with concurrent TAU	Online cognitive behavioral therapy	Those randomized into the this group will get immediate e-CBT with TAU.

Primary Outcome Measures

Name	Time	Method
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 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.
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.

Secondary Outcome Measures

Name	Time	Method
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 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.
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.
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.
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 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 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.
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.

Trial Locations

Locations (1)

Stavanger University Hospital, Norwegian Centre for Movement Disorders; 🇳🇴 Stavanger, Norway