NCT07687420

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
6mo left

Started Sep 2026

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 18, 2026

Completed
19 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2027

Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 18, 2026

Last Update Submit

July 1, 2026

Conditions

Anxious Symptoms

Keywords

AnxietyOlder adultsAcceptance and Commitment TherapyMental healthPsychological flexibilityVirtual reality

Outcome Measures

Primary Outcomes (3)

  • Intervention adherence

    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

    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)

    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 Outcomes (3)

  • Anxiety symptoms

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

  • Psychological flexibility

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

  • Self-compassion

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

Study Arms (2)

ACT + VR

EXPERIMENTAL

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

Wait-list Control

NO INTERVENTION

Participants remain on a wait-list during the study period and receive the intervention after completion of post-intervention assessments.

Interventions

Intervention program based on Acceptance and Commitment TherapyBEHAVIORAL

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

ACT + VR

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Anxiety DisordersPsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersPersonal SatisfactionBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: One experimental group and one wait-list control group.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD Student

Study Record Dates

First Submitted

June 18, 2026

First Posted

July 7, 2026

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

March 1, 2027

Last Updated

July 7, 2026

Record last verified: 2026-07