About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Currently undergoing any form of psychology intervention
Pregnancy
Current suicidal ideation
Diagnosis of severe psychiatric illness (e.g., severe depression, psychotic illness, bipolar disorder)
Trial design
Parallel
Treatments tested in this trial
Empower your mind to embrace your life
BehavioralAn eight-session Acceptance and Commitment Therapy (ACT) for young-onset Parkinson's disease, applied in a group format and delivered online (via videoconferencing).
Treatment groups
Trial outcomes
Primary outcomes
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.
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.
Secondary outcomes
Psy-Flex for Chronic Illness (Psy-Flex-CI)
The Psy-Flex-CI assesses chronic illness-related psychological flexibility through 6 items, each referring to one of the six core ACT processes. Participants were instructed to answer according to a 5-point Likert scale (1 = Almost never; 5 = Almost always). This self-report measure was developed and validated within the scope of this research project and presents good psychometric properties.
Multidimensional Psychological Flexibility Inventory - 24 (MPFI-24)
The MPFI-24 is a self-report measure that assesses psychological flexibility and inflexibility. The scale consists of 24 items answered on a 6-point Likert scale (ranging from 1 = Never true to 6 = Always true), referring to the last 2 weeks. The scores can be averaged to create a composite score representing global psychological flexibility and inflexibility, respectively. Previous psychometric information demonstrates adequate psychometric properties, including good internal consistency values.
Cognitive Fusion Questionnaire - Chronic Illness (CFQ-CI)
The CFQ-CI is a 7-item measure of cognitive fusion specifically related to the experience of having a chronic illness and its symptomatology. Items are rated on a 7-point Likert scale ranging from 1 (Never true) to 7 (Always true). CFQ-CI has demonstrated excellent internal reliability.
The Mindful Attention and Awareness Scale (MAAS)
The MAAS is a self-report measure of mindfulness at a trait-level, designed to assess attention and awareness of present moment daily activities. The scale consists of 15 items rated on a 6-point Likert scale (1 = Almost always; 6 = Almost never). Higher scores reflect greater dispositional mindfulness. This instrument has demonstrated good internal consistency.
Other outcomes
Patient Health Questionnaire - 9 (PHQ-9)
This brief questionnaire is a screening tool based on the DSM-IV criteria for major depressive disorder that assess the severity of depression symptoms (e.g., depressed mood, loss of interest, fatigue, and suicidal ideation). The scale consists of 9 items rated on a 4-point Likert scale (0 = Not at all, 3 = Nearly every day). The scale also comprises an additional item assessing the impact of symptoms on functioning (ranging from Not difficult at all to Extremely difficult). Higher scores indicate more severe depression symptoms. The scale showed good internal consistency.
Non-motor Symptoms Questionnaire (NMSQuest)
This instrument was designed to detect Parkinson's disease specific non-motor manifestations in several domains (e.g., depression and anxiety symptoms, cardiovascular, sexual function, sleep disorder) and comprises 30 items. Each item is answered according to a "yes" or "no" scale. Higher scores indicate higher frequency of non-motor manifestations.
Sponsors and contacts
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University of Coimbra
Lead sponsor
Foundation for Science and Technology, Portugal
Collaborator