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

Intervention Based on Acceptance and Commitment Therapy Enhanced With Virtual Reality for Older Adults With Anxiety Symptoms: A Pilot Randomized Controlled Trial

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07687420
Enrollment
60
Registered
2026-07-07
Start date
2026-09-01
Completion date
2027-03-01
Last updated
2026-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxious Symptoms

Keywords

Anxiety, Older adults, Acceptance and Commitment Therapy, Mental health, Psychological flexibility, Virtual reality

Brief summary

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.

Interventions

BEHAVIORALIntervention program based on Acceptance and Commitment Therapy

An intervention program based on Acceptance and Commitment Therapy, consisting of 12 group sessions, with virtual reality being used in selected sessions.

Sponsors

Grupo Lusófona
Lead SponsorOTHER
Fundação para a Ciência e a Tecnologia
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

One experimental group and one wait-list control group.

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Participants aged 65 or older; * Participants with mild, moderate, or severe anxiety symptoms; * Participants who attend day centers.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Intervention adherenceThroughout the intervention period (6 weeks)Proportion of participants who complete all intervention sessions. Adherence will be considered acceptable if at least 70% of participants complete the programme
Acceptability and feasibility of the intervention assessed by TFAPost-intervention (at week 7)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.
Acceptability and perceived barriers (semi-structured interviews)Post-intervention (at week 7)Individual semi-structured interviews conducted after intervention completion to explore participants' experiences, satisfaction, perceived benefits, barriers to engagement, and suggestions for improvement

Secondary

MeasureTime frameDescription
Anxiety symptomsBaseline, post-intervention (week 7) and follow-up (3 months)Changes in the Geriatric Anxiety Inventory (GAI). Scores range from 0 do 20, and higher scores indicate higher levels of anxiety symptoms.
Psychological flexibilityBaseline, post-intervention (week 7) and follow-up (3 months)Changes in the MindFlex Scale. Scores range from 27 to 189, and higher scores indicate higher levels of psychological flexibility.
Self-compassionBaseline, post-intervention (week 7) and follow-up (3 months)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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 8, 2026