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Not yet recruiting NCT07687420

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

No phase Interventional Anxious Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Intervention program based on Acceptance and Commitment Therapy.
Who it may be relevant to
Registry conditions: Anxious Symptoms. Basic parameters: from 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

  • 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.

Primary outcome measures

  • Intervention adherence [Time frame: Throughout the intervention period (6 weeks)]
  • Acceptability and feasibility of the intervention assessed by TFA [Time frame: Post-intervention (at week 7)]
  • Acceptability and perceived barriers (semi-structured interviews) [Time frame: Post-intervention (at week 7)]
Secondary outcome measures (3)
  • Anxiety symptoms [Time frame: Baseline, post-intervention (week 7) and follow-up (3 months)]
  • Psychological flexibility [Time frame: Baseline, post-intervention (week 7) and follow-up (3 months)]
  • Self-compassion [Time frame: Baseline, post-intervention (week 7) and follow-up (3 months)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07687420 · 2023.02357.BDANA

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗