Anxious SymptomsNCT07687420
ACT-based Intervention Enhanced With VR for Older Adults With Anxiety Symptoms
A study testing Intervention program based on Acceptance and Commitment Therapy in people with Anxious Symptoms, run by Grupo Lusófona.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Anxious Symptoms
- What is being tested?
- Intervention program based on Acceptance and Commitment Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Sep 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Participants aged 65 or older;
- Participants with mild, moderate, or severe anxiety symptoms;
- Participants who attend day centers.
Who cannot join
- 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.
About this study
Official title: 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.
- Conditions
- Anxious Symptoms
- Being tested
- Intervention program based on Acceptance and Commitment Therapy
- Keywords
- Anxiety, Older adults, Acceptance and Commitment Therapy, Mental health, Psychological flexibility, Virtual reality
- Medical subject headings
- Anxiety Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention program based on Acceptance and Commitment TherapyBehavioural
An intervention program based on Acceptance and Commitment Therapy, consisting of 12 group sessions, with virtual reality being used in selected sessions.
| Study group | Role | What they receive |
|---|---|---|
| ACT + VR | Experimental | Participants receive an Acceptance and Commitment Therapy intervention that incorporates virtual reality experiences in selected sessions. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention adherence
Proportion of participants who complete all intervention sessions. Adherence will be considered acceptable if at least 70% of participants complete the programme
Measured: 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.
Measured: 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
Measured: Post-intervention (at week 7)
Secondary outcomes (3)
Anxiety symptoms
Changes in the Geriatric Anxiety Inventory (GAI). Scores range from 0 do 20, and higher scores indicate higher levels of anxiety symptoms.
Measured: Baseline, post-intervention (week 7) and follow-up (3 months)
Psychological flexibility
Changes in the MindFlex Scale. Scores range from 27 to 189, and higher scores indicate higher levels of psychological flexibility.
Measured: Baseline, post-intervention (week 7) and follow-up (3 months)
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.
Measured: Baseline, post-intervention (week 7) and follow-up (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxious SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- One experimental group and one wait-list control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Lusófona
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Responsible party
- Principal investigator, Marta Barata, Grupo Lusófona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07687420
- Sponsor's protocol ID
- 2023.02357.BDANA
- Other IDs
- 2023
- Status last verified
- Jul 2026
- First submitted
- 18 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intervention Based on Acceptance and Commitment Therapy Enhanced With Virtual Reality for Older Adults With Anxiety Symptoms: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07687420
- Acronym / sponsor ID
- 2023.02357.BDANA
- Conditions
- Anxious Symptoms
- Keywords
- Anxiety, Older adults, Acceptance and Commitment Therapy, Mental health, Psychological flexibility, Virtual reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Grupo LusófonaUniversity, hospital or other
- Collaborators
- Fundação para a Ciência e a Tecnologia
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- One experimental group and one wait-list control group.
| Arm | Type | Receives |
|---|---|---|
| ACT + VR | Experimental | Behavioral: Intervention program based on Acceptance and Commitment TherapyParticipants receive an Acceptance and Commitment Therapy intervention that incorporates virtual reality experiences in selected sessions. |
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Participants aged 65 or older;
- Participants with mild, moderate, or severe anxiety symptoms;
- Participants who attend day centers.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention program based on Acceptance and Commitment TherapyAn intervention program based on Acceptance and Commitment Therapy, consisting of 12 group sessions, with virtual reality being used in selected sessions. | Behavioural | ACT + VR |
Primary outcome
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
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.
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
3 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention program based on Acceptance and Commitment Therapy in people with Anxious Symptoms, run by Grupo Lusófona.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention adherence (time frame: Throughout the intervention period (6 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.