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

NCT ID: NCT05585827

Last Updated: 2024-12-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-07
• Study Completion Date: 2024-11-27

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.

Conditions

Parkinson Disease; Depressive Symptoms; Anxiety

Keywords

Parkinsons disease; Neuropsychiatry; Cognitive behavioral therapy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Immediate eCBT with concurrent TAU

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

Group Type: EXPERIMENTAL

Online cognitive behavioral therapy

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Helse Stavanger HF

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksander H Erga, PhD

Role: PRINCIPAL_INVESTIGATOR

Norwegian Centre for Movement Disorders, Stavanger University Hospital

Locations

Stavanger University Hospital, Norwegian Centre for Movement Disorders

Stavanger, , Norway

Countries

Norway

References

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.

Reference Type: BACKGROUND

PMID: 36817735 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 37745287 (View on PubMed)

Related Links

https://www.helse-stavanger.no/fag-og-forskning/kompetansetjenester/senter-for-bevegelsesforstyrrelser/epark-studien

Study website (Norwegian)

Other Identifiers

3414-3414

Identifier Type: -

Identifier Source: org_study_id