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| Name | Class |
|---|---|
| Fundação para a Ciência e a Tecnologia | OTHER |
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The goal of this pilot RCT is to develop, implement and evaluate an Intervention Program based on Acceptance and Commitment Therapy using virtual reality as one of the components, in a sample of individuals aged 65 or older with anxiety symptoms enrolled in Portuguese day centers, with the aim of evaluating the feasibility, acceptability and preliminary evidence of efficacy of the intervention program and exploring the attitudes, behaviors and perceived barriers on the part of the participants towards the intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ACT + VR | Experimental | Participants receive an Acceptance and Commitment Therapy intervention that incorporates virtual reality experiences in selected sessions. |
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| Wait-list Control | No Intervention | Participants remain on a wait-list during the study period and receive the intervention after completion of post-intervention assessments. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intervention program based on Acceptance and Commitment Therapy | Behavioral | An intervention program based on Acceptance and Commitment Therapy, consisting of 12 group sessions, with virtual reality being used in selected sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| Intervention adherence | Proportion of participants who complete all intervention sessions. Adherence will be considered acceptable if at least 70% of participants complete the programme | Throughout the intervention period (6 weeks) |
| Acceptability and feasibility of the intervention assessed by TFA | Acceptability and feasibility assessed with the theoretical framework of acceptability questionnaire (TFA). Items are rated on a 5-point Likert scale ranging from 1 to 5. Scores range from 7 to 35, and a higher score corresponds to greater acceptability and feasibility. | Post-intervention (at week 7) |
| Acceptability and perceived barriers (semi-structured interviews) | Individual semi-structured interviews conducted after intervention completion to explore participants' experiences, satisfaction, perceived benefits, barriers to engagement, and suggestions for improvement | Post-intervention (at week 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Anxiety symptoms | Changes in the Geriatric Anxiety Inventory (GAI). Scores range from 0 do 20, and higher scores indicate higher levels of anxiety symptoms. | Baseline, post-intervention (week 7) and follow-up (3 months) |
| Psychological flexibility |
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Inclusion Criteria:
Exclusion Criteria:
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| ID | Term |
|---|---|
| D001008 | Anxiety Disorders |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |
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One experimental group and one wait-list control group.
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Changes in the MindFlex Scale. Scores range from 27 to 189, and higher scores indicate higher levels of psychological flexibility.
| Baseline, post-intervention (week 7) and follow-up (3 months) |
| Self-compassion | Changes in the Self-Compassion Scale - Short Form (SCS-SF). Scores range from 12 to 60, and higher scores indicate higher levels of self-compassion. | Baseline, post-intervention (week 7) and follow-up (3 months) |