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NCT Number: NCT07687420

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

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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Key information

Conditions

Anxious Symptoms Anxiety Disorders Behavior Mental Disorders Personal Satisfaction Psychological Well-Being

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Grupo Lusófona

Other

Collaborators

  • Fundação para a Ciência e a Tecnologia

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 7, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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