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

NCT07310147 | Recruiting

• 1 other identifier: 2022.12842.BD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson's Disease (PD)

Keywords

Acceptance and Commitment Therapy; Parkinson's disease; Psychological Flexibility; Online group intervention

Outcome Measures

Primary Outcomes (2)

• Parkinson's Disease Questionnaire - short form (PDQ-8)

  The PDQ-8 was used to measure Parkinson's disease specific health-related quality of life through 8 items. This self-report instrument covers domains such as mobility, activities of daily living, emotional well-being, social support, communication, cognition, bodily discomfort and stigma. Each item is answered on a five-point Likert scale (ranging from 0 = Never; 4 = Always or cannot do at all). Higher scores on PDQ-8 represent poor health-related quality of life. Previous psychometric studies found very good internal consistency values. This measure was validated to the Portuguese population within the scope of this research project and showed good internal consistency.

  Baseline, Week 8, 3-month follow-up

• Hospital Anxiety and Depression Scale (HADS)

  The HADS is a self-report measure designed to assess the presence and severity of depressive and anxiety symptoms over the past week. This instrument comprises 14 items rated on a 4-point Likert scale ranging from 0 (Did not apply to me at all) to 3 (Applied to me very much or Most of the time). Higher scores indicate greater depression and anxiety symptomatology. The HADS presented good internal consistency in the original and in the Portuguese versions.

  Baseline, Week 8, 3-month follow-up

Secondary Outcomes (7)

• Psy-Flex for Chronic Illness (Psy-Flex-CI)

  Baseline, Week 8, 3-month follow-up

• Multidimensional Psychological Flexibility Inventory - 24 (MPFI-24)

  Baseline, Week 8, 3-month follow-up

• Cognitive Fusion Questionnaire - Chronic Illness (CFQ-CI)

  Baseline, Week 8, 3-month follow-up

• The Mindful Attention and Awareness Scale (MAAS)

  Baseline, Week 8, 3-month follow-up

• External and Internal Shame Scale (EISS)

  Baseline, Week 8, 3-month follow-up

Other Outcomes (2)

• Patient Health Questionnaire - 9 (PHQ-9)

  Baseline

• Non-motor Symptoms Questionnaire (NMSQuest)

  Baseline

Study Arms (2)

Control Group

NO INTERVENTION

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.

Intervention Group

EXPERIMENTAL

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.

Behavioral: Empower your mind to embrace your life

Interventions

Empower your mind to embrace your life 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).

Intervention Group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Coimbra: lead
• Foundation for Science and Technology, Portugal: collaborator

Study Sites (1)

CINEICC

Coimbra, 3000-115, Portugal

RECRUITING

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Inês Matos-Pina, MSc

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

  PRINCIPAL INVESTIGATOR

• Cláudia Ferreira, PhD

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

  PRINCIPAL INVESTIGATOR

• Mariana Moura-Ramos, PhD

  Unidade Local de Saúde de Coimbra (ULS Coimbra)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Inês Matos-Pina, MSc

CONTACT

+351968766690; inescpina@hotmail.com

Claudia Ferreira, PhD

CONTACT

claudiaferreira@fpce.uc.pt

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This project will follow a longitudinal design. Individuals presenting a clinically established young-onset PD diagnosis will be allocated to the Control Group (no intervention; n ≥ 10) or to the Experimental Group (Empower your mind to embrace your life group intervention; n ≥ 10).

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: April 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PT (1)