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Not yet recruitingNCT07687420Updated Jul 7, 2026

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

An interventional study of Intervention program based on Acceptance and Commitment Therapy in Anxious Symptoms, sponsored by Grupo Lusófona. Not yet recruiting. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2026-07-07.

Primary conditionAnxiety Disorders(the registry's first term)UnverifiedIs this wrong?The registry often attaches Anxiety Disorders to studies about something else, and this study's title and listed conditions do not name it. No better condition is named, so the registry's term is kept.

Sponsored by Grupo Lusófona · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Anxious Symptoms

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Keywords

  • Anxiety
  • Older adults
  • Acceptance and Commitment Therapy
  • Mental health
  • Psychological flexibility
  • Virtual reality
03

In context

Anxiety Disorders Unverified

7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.

This study's planned enrollment of 60 is below the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.

Browse Anxiety Disorders studies →

Lead sponsor

Grupo Lusófona is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Participants with a medical diagnosis of neurocognitive disorder or with significant cognitive deficits (measured with );
  • Participants with illiteracy or with linguistic difficulties that hinder communication and the comprehension of instructions;
  • Participants with reduced visual acuity.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
60 participants (estimated)

Study arms

  • 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

  • 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.

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.

06

What researchers measure

Primary outcomes

  1. Intervention adherence

    Proportion of participants who complete all intervention sessions. Adherence will be considered acceptable if at least 70% of participants complete the programme

    Time frame: Throughout the intervention period (6 weeks)

  2. 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.

    Time frame: Post-intervention (at week 7)

  3. 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

    Time frame: Post-intervention (at week 7)

Secondary outcomes

  1. Anxiety symptoms

    Changes in the Geriatric Anxiety Inventory (GAI). Scores range from 0 do 20, and higher scores indicate higher levels of anxiety symptoms.

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

  2. Psychological flexibility

    Changes in the MindFlex Scale. Scores range from 27 to 189, and higher scores indicate higher levels of psychological flexibility.

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

  3. Self-compassion

    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.

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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Sep 2026; primary completion for Mar 2027, 6 months later.

Of 3,836 non-industry interventional studies with no phase under Anxiety Disorders, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 28. This study's planned 6 months is below that.

Counting every sponsor, half of 3,938 studies reached it within 12 months; a quarter within 5 and three quarters within 28.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2026
First posted
Jul 7, 2026
StartEst.
Sep 2026
Primary completionEst.
Mar 2027
CompletionEst.
Mar 2027
Last update
Jul 7, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 7, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07687420
Lead sponsor
Grupo Lusófona
Collaborators
Fundação para a Ciência e a Tecnologia
Responsible party
Marta Barata (PhD Student, Grupo Lusófona) — Principal investigator
First posted
Jul 7, 2026
Start date
Sep 2026 (estimated)
Primary completion
Mar 2027 (estimated)
Completion
Mar 2027 (estimated)
Last update
Jul 7, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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