Empower Your Mind to Embrace Your Life: an Online ACT Intervention for Young-Onset Parkinson's Disease

NCT ID: NCT07310147

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-06-30

Brief Summary

Parkinson's disease (PD) has a substantial impact on daily life and significantly affects functioning, mental health and quality of life. Although considered a disease of the elderly, an early diagnosis is also common. Non-pharmacological interventions have been increasingly recommended for PD, including psychotherapy, with emerging evidence suggesting that Acceptance and Commitment Therapy (ACT) may be suitable to support individuals living with PD. This project aims to expand the current evidence for ACT interventions in this population by developing, implementing, and investigating the preliminary efficacy of a novel online-delivered ACT intervention (Empower your mind to embrace your life) for individuals with a diagnosis of young-onset PD. For this purpose, a feasibility study will be conducted to assess the acceptability and preliminary efficacy of the intervention across two groups (control and ACT intervention). This group-based intervention consists of eight weekly sessions and will be delivered in an online format (via videoconferencing). Outcome measurement will be assessed at pre-intervention, post-intervention, and at 3-month follow-up. When comparing changes in outcome variables between the control and intervention groups at post-treatment, improvements are expected only in the intervention group. These improvements are also expected to be maintained over time (at 3-month follow-up). Lastly, changes in psychological (in)flexibility processes are expected to predict changes in outcome variables in the intervention group. This study will provide important insights to research and clinical practice by providing data on the feasibility and preliminary efficacy of this novel ACT-based intervention for the context of young-onset PD.

Detailed Description

Parkinson's disease (PD) is a complex, progressive neurodegenerative disease that predominantly affects movement. Although considered a disease of the elderly, an early diagnosis is also common and entails unique challenges that significantly affect several domains of life. PD is characterized by a multitude of motor (e.g., bradykinesia, resting tremor, rigidity) and non-motor symptoms (NMS, e.g., depression, pain, fatigue). Specifically, NMS have received increasing attention due to their detrimental impact on individuals' functioning, mental health outcomes and overall quality of life. In fact, NMS can be as disabling as motor PD manifestations, particularly in people with young-onset PD.

In recent years, non-pharmacological interventions have been developed with the aim of improving overall quality of life and managing NMS, including psychotherapy. In particular, third-wave psychological interventions have been applied in the context of PD with promising results, and literature has specifically highlighted Acceptance and Commitment Therapy (ACT) as a transdiagnostic model that appears to be well-suited for helping individuals with PD manage the challenges associated with their symptoms. The overarching goal of ACT is to increase psychological flexibility, a core process defined as the ability to be fully in contact with the present moment, with an accepting and nonjudgmental attitude, while behaving according to one's values. Evidence supports ACT's efficacy in several chronic physical illnesses, but few studies have implemented such interventions in adults diagnosed with PD. Despite promising results, current evidence remains limited and preliminary.

Additionally, literature highlighted the relevance of technology-supported psychological interventions in providing more cost-effective interventions for healthcare systems, especially in the context of chronic conditions. Notably, videoconferencing has been shown to be effective in overcoming face-to-face intervention-related barriers (e.g., mobility limitations, transport), which is particularly relevant in the context of PD.

Considering this background, the current project aims to contribute to the advance of ACT-based interventions in this field by developing, implementing, and examining the feasibility and preliminary efficacy of the "Empower your mind to embrace your life" intervention. This innovative ACT-based intervention was designed specifically to the context of young-onset PD and will be delivered online, in group format. The feasibility, acceptability and preliminary efficacy will be tested using a parallel-arm study, comparing the intervention with a control condition/waiting list (individuals with an early-onset PD diagnosis that will not receive any type of psychological intervention during the course of the study). Our hypothesis is that by targeting ACT core processes (e.g., acceptance, mindfulness, values), not only functioning and psychological outcomes will improve, but overall quality of life will be positively impacted. For this purpose, a longitudinal design will be implemented, including three assessment moments: baseline, post-intervention and 3-month follow-up (primary outcomes: health-related quality of life and psychopathology indicators -depression and anxiety symptoms; secondary outcomes: ACT core processes [chronic illness-specific and general psychological flexibility, chronic illness-related cognitive fusion, mindfulness], and other relevant outcomes, such as body functionality, shame). All procedures inherent to this research project were approved by the Ethics Committees of the Faculty of Psychology and Educational Sciences, University of Coimbra; Coimbra Local Health Unit (ULS Coimbra), and Hospital da Luz Coimbra. All participants provided their informed consent prior to data collection. The voluntary, confidential and pseudo-anonymized nature of the study was clearly explained. Participants were also informed about the option to decline participation or withdraw at any moment without any negative consequence. All participants will maintain their usual medical treatment, which includes medication for managing PD-related symptoms.

Conditions

Parkinson's Disease (PD)

Study Design

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

Study Groups

Control Group

Group of participants with young-onset diagnosis of Parkinson's disease (n ≥ 10) not subjected to any psychological intervention within the current study. Participants will be assessed at baseline, at post-intervention (immediately after session 8 of the intervention program), and at 3-month follow-up.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention Group

Group of participants with young-onset diagnosis of Parkinson's disease (n ≥ 10) subjected to an 8-week online psychological intervention delivered in a group format (Empower your mind to embrace your life intervention). Participants in the experimental group will be assessed at baseline, post-intervention (immediately after session 8 of the intervention program), and at 3-month follow-up.

Group Type: EXPERIMENTAL

Empower your mind to embrace your life

Intervention Type: BEHAVIORAL

An eight-session Acceptance and Commitment Therapy (ACT) for young-onset Parkinson's disease, applied in a group format and delivered online (via videoconferencing).

Interventions

Empower your mind to embrace your life

An eight-session Acceptance and Commitment Therapy (ACT) for young-onset Parkinson's disease, applied in a group format and delivered online (via videoconferencing).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Young-onset PD diagnosis confirmed by a neurologist
• Classification between stages 1 and 2.5 according to the Hoehn &Yahr scale
• Aged between 21-65 years
• Fluent Portuguese speakers

Exclusion Criteria

• Currently undergoing any form of psychology intervention
• Pregnancy
• Current suicidal ideation
• Diagnosis of severe psychiatric illness (e.g., severe depression, psychotic illness, bipolar disorder)
• Cognitive impairment

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Coimbra

OTHER

Sponsor Role: lead

Foundation for Science and Technology, Portugal

OTHER

Sponsor Role: collaborator

Responsible Party

Inês Carolina Andrade Matos Pina

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Inês Matos-Pina, MSc

Role: PRINCIPAL_INVESTIGATOR

CINEICC - Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences of the University of Coimbra

Cláudia Ferreira, PhD

Role: PRINCIPAL_INVESTIGATOR

CINEICC - Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences of the University of Coimbra

Mariana Moura-Ramos, PhD

Role: PRINCIPAL_INVESTIGATOR

Unidade Local de Saúde de Coimbra (ULS Coimbra)

Locations

CINEICC

Coimbra, , Portugal

Site Status: RECRUITING

Countries

Portugal

Central Contacts

Inês Matos-Pina, MSc

Role: CONTACT

inescpina@hotmail.com

+351968766690

Claudia Ferreira, PhD

Role: CONTACT

claudiaferreira@fpce.uc.pt

Facility Contacts

Inês Matos-Pina, MSc

Role: primary

inescpina@hotmail.com

+351968766690

Cláudia Ferreira, PhD

Role: backup

Other Identifiers

2022.12842.BD

Identifier Type: -

Identifier Source: org_study_id