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ACT-based Intervention Enhanced With VR for Older Adults With Anxiety Symptoms

ConditionAnxious Symptoms
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorGrupo Lusófona

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants aged 65 or older;

Participants with mild, moderate, or severe anxiety symptoms;

Participants who attend day centers.

Disqualifiers

Participants with a medical diagnosis of neurocognitive disorder or with significant cognitive deficits (measured with Mini-Mental State Examination);

Participants with illiteracy or with linguistic difficulties that hinder communication and the comprehension of instructions;

Participants with reduced visual acuity.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: ACT + VRExperimental treatment 1 intervention
Group B: Wait-list ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Intervention adherence

Proportion of participants who complete all intervention sessions. Adherence will be considered acceptable if at least 70% of participants complete the programme

Time frame
Throughout the intervention period (6 weeks)
2

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.

Time frame
Post-intervention (at week 7)
3

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

Time frame
Post-intervention (at week 7)

Secondary outcomes

1

Anxiety symptoms

Changes in the Geriatric Anxiety Inventory (GAI). Scores range from 0 do 20, and higher scores indicate higher levels of anxiety symptoms.

Time frame
Baseline, post-intervention (week 7) and follow-up (3 months)
2

Psychological flexibility

Changes in the MindFlex Scale. Scores range from 27 to 189, and higher scores indicate higher levels of psychological flexibility.

Time frame
Baseline, post-intervention (week 7) and follow-up (3 months)
3

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.

Time frame
Baseline, post-intervention (week 7) and follow-up (3 months)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grupo Lusófona

Lead sponsor

Fundação para a Ciência e a Tecnologia

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: