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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
| University of Bergamo | OTHER |
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This clinical trial aims to explore if a virtual reality experience increases the beneficial effect of psychoeducational programs in informal caregivers of people with mild-to-moderate Alzheimer's disease. This study will test changes in psychological distress and neural activity in brain systems that regulate stress and empathic care.
Participants will be randomized into two arms: the control group will participate in an online psychoeducational intervention, while the experimental group will participate in the psychoeducational intervention combined with virtual reality.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | Psychoeducational program. |
|
| Experimental group | Experimental | Psychoeducational program combined with virtual reality. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducation | Behavioral | 6 sessions of 2 hours over 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in distress of care after intervention | Zarit Burden interview - ZBI | Baseline (pre-intervention); Post-intervention (up to a week post-intervention). |
| Change in anxiety | State Trait Anxiety Inventory - STAI-Y | Baseline (pre-intervention); Post-intervention (up to a week post-intervention). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in empathy | Interpersonal Reactivity Index - IRI | Baseline (pre-intervention); Post-intervention (up to a week post-intervention). |
| Change in sense of competence | Short sense of competence questionnaire - SSCQ |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence of medium-term effects - distress of care | Zarit Burden interview - ZBI | 2 months post-intervention. |
| Persistence of medium-term effects - anxiety | State Trait Anxiety Inventory - STAI-Y |
Inclusion Criteria:
Exclusion Criteria:
Exclusion Criteria for experimental group (Psychoeducation + VR):
Exclusion Criteria for subsample of caregivers assess with MRI:
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| Name | Affiliation | Role |
|---|---|---|
| Cristina Festari, PhD | IRCCS Istituto Centro San Giovanni di Dio Fatebenefratelli, Brescia, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Centro San Giovanni di Dio Fatebenefratelli | Brescia | Italy | 25125 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32695039 | Background | Morganti F, Palena N, Savoldelli P, Greco A. Take the First-Person Perspective to Become Dementia-Friendly: The Use of 360 degrees Video for Experiencing Everyday-Life Challenges With Cognitive Decline. Front Psychol. 2020 Jun 30;11:1117. doi: 10.3389/fpsyg.2020.01117. eCollection 2020. | |
| 39335348 | Result | Morganti F, Gattuso M, Singh Solorzano C, Bonomini C, Rosini S, Ferrari C, Pievani M, Festari C. Virtual Reality-Based Psychoeducation for Dementia Caregivers: The Link between Caregivers' Characteristics and Their Sense of Presence. Brain Sci. 2024 Aug 23;14(9):852. doi: 10.3390/brainsci14090852. |
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| ID | Term |
|---|---|
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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Two-arm randomized controlled design
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| Psychoeducation + virtual reality |
| Behavioral |
6 sessions of 2 hours over 6 weeks. Virtual reality experience will be carry out in the last 30 minutes of each meeting. Virtual reality consists of 360-degree videos depicting everyday situations and allowing the caregivers to feel the specific symptoms of dementia (e.g., disorientation, agnosia, apraxia and memory loss). |
|
| Baseline (pre-intervention); Post-intervention (up to a week post-intervention). |
| Modulation of neural activity in brain systems regulating empathy | Task fMRI | Baseline (pre-intervention); Post-intervention (up to a week post-intervention). |
| 2 months post-intervention. |
| Persistence of medium-term effects - empathy | Interpersonal Reactivity Index - IRI | 2 months post-intervention. |
| Persistence of medium-term effects - sense of competence | Short sense of competence questionnaire - SSCQ | 2 months post-intervention. |
| 39267224 | Result | Festari C, Bonomini C, Rosini S, Gattuso M, Singh Solorzano C, Zanetti O, Corbo D, Agnelli G, Quattrini G, Ferrari C, Gasparotti R, Pievani M, Morganti F. Virtual Reality Combined With Psychoeducation to Improve Emotional Well-Being in Informal Caregivers of Alzheimer's Disease Patients: Rationale and Study Design of a Randomized Controlled Trial. Int J Geriatr Psychiatry. 2024 Sep;39(9):e6145. doi: 10.1002/gps.6145. |
| 40908671 | Derived | Singh Solorzano C, Bonomini C, Rosini S, Passeggia I, Zanetti O, Pievani M, Frisoni GB, Festari C. The psychological impact of the disclosure of the diagnosis of Alzheimer's disease on informal caregivers. Alzheimers Dement. 2025 Sep;21(9):e70412. doi: 10.1002/alz.70412. |