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

July 1, 2026 updated by: Marta Barata, Grupo Lusófona

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ACT + VR
Participants receive an Acceptance and Commitment Therapy intervention that incorporates virtual reality experiences in selected sessions.
Behavioral: Intervention 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.
No Intervention: Wait-list Control
Participants remain on a wait-list during the study period and receive the intervention after completion of post-intervention assessments.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention adherence
Time Frame: Throughout 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
Throughout the intervention period (6 weeks)
Acceptability and feasibility of the intervention assessed by TFA
Time Frame: Post-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.
Post-intervention (at week 7)
Acceptability and perceived barriers (semi-structured interviews)
Time Frame: 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
Post-intervention (at week 7)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety symptoms
Time Frame: Baseline, 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.
Baseline, post-intervention (week 7) and follow-up (3 months)
Psychological flexibility
Time Frame: Baseline, 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.
Baseline, post-intervention (week 7) and follow-up (3 months)
Self-compassion
Time Frame: Baseline, 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.
Baseline, post-intervention (week 7) and follow-up (3 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Grupo Lusófona

Collaborators

Fundação para a Ciência e a Tecnologia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

June 18, 2026

First Submitted That Met QC Criteria

July 1, 2026

First Posted (Actual)

July 7, 2026

Study Record Updates

Last Update Posted (Actual)

July 7, 2026

Last Update Submitted That Met QC Criteria

July 1, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023.02357.BDANA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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