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

NCT05585827 | Completed DMC

• 1 other identifier: 3414-3414
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease; Depressive Symptoms; Anxiety

Keywords

Parkinsons disease; Neuropsychiatry; Cognitive behavioral therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (8)

• Change in the Automatic Thoughts Questionnaire-30- Negative (ATQ-30-N) score

  Baseline, 14, 28 and 42 weeks

• Change in the The Behavioural Activation for Depression Scale (BADS) score

  Baseline, 14, 28 and 42 weeks

• Change in The 39-item PD Questionnaire (PDQ-8) score

  Baseline, 14, 28 and 42 weeks

• The Negative Effects Questionnaire (NEQ)

  14, 28 and 42 weeks

• Change in the Parkinson Anxiety Scale (PAS) score

  Baseline, 14, 28 and 42 weeks

Study Arms (2)

Immediate eCBT with concurrent TAU

EXPERIMENTAL

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

Behavioral: Online cognitive behavioral therapy

Delayed eCBT with concurrent TAU

NO INTERVENTION

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.

Interventions

Online cognitive behavioral therapy BEHAVIORAL

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.

Immediate eCBT with concurrent TAU

Eligibility Criteria

• Age: 35 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Stavanger HF: lead

Study Sites (1)

Stavanger University Hospital, Norwegian Centre for Movement Disorders

Stavanger, 4068, Norway

Location

Related Publications (2)

• 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.

  PMID: 36817735 BACKGROUND

• 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.

  PMID: 37745287 BACKGROUND

Related Links

• Study website (Norwegian)

MeSH Terms

Conditions

Parkinson Disease; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Aleksander H Erga, PhD

  Norwegian Centre for Movement Disorders, Stavanger University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This study is a online, randomized delayed start trial of the effectiveness of e-CBT for PD patients with depressive symptoms.

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: October 19, 2022
• Study Start: December 7, 2022
• Primary Completion: November 27, 2024
• Study Completion: November 27, 2024
• Last Updated: December 5, 2024

Record last verified: 2024-11

Locations

NO (1)