An Online Home-based Intervention for Anxiety Regulation

NCT04626713 | Unknown

• 1 other identifier: 2020-220
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this project is to evaluate the safety and acceptability of our online, home-based, personalized, neuro-technological mindfulness-based intervention in entraining anxiety regulation and ameliorating anxiety in healthy adults. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an electroencephalography (EEG) algorithm. We hypothesize that the intervention would be safe and acceptable. In exploratory analyses, we further hypothesize that the intervention would help entrain anxiety regulation and ameliorate anxiety in healthy adults. Data will be analyzed quantitatively and qualitatively to inform development of our intervention and future research studies.

Conditions

Anxiety

Keywords

Anxiety; Biofeedback; Intervention

Outcome Measures

Primary Outcomes (8)

• Beck Anxiety Inventory II (BAI-II)

  21-item questionnaire being scored on a scale value of 0 (not at all) to 3 (severely). Higher total scores indicate more severe anxiety symptoms.

  Intervention group: Changes from baseline anxiety symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline anxiety symptoms (week 1) to pre-intervention (week 4) and post-intervention (week 7).

• State-trait Anxiety Inventory (STAI)

  4-point Likert scale and consisting of 40 questions measuring two types of anxiety - state and trait anxiety.

  Intervention group: Changes from baseline anxiety symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline anxiety symptoms (week 1) to pre-intervention (week 4) and post-intervention (week 7).

• Usability questionnaire (System usability questionnaire)

  Participants will rate their agreeableness on 10 statements regarding their satisfaction and ease of use of the training components on a 5-point Likert scale. Participants will also answer three qualitative questions regarding their satisfaction and ease of use.

  Intervention group: Week 4 (post-intervention).

• IT Anxiety Scale (ITAS)

  7-point Likert scale and consisting of 12 statements measuring participants' anxiety towards information and communication technologies.

  Intervention group: Week 4 (post-intervention).

• Usability questionnaire (System usability questionnaire)

  Participants will rate their agreeableness on 10 statements regarding their satisfaction and ease of use of the training components on a 5-point Likert scale. Participants will also answer three qualitative questions regarding their satisfaction and ease of use.

  Waitlist control group: Week 7 (post-intervention).

• IT Anxiety Scale (ITAS)

  7-point Likert scale and consisting of 12 statements measuring participants' anxiety towards information and communication technologies.

  Waitlist control group: Week 7 (post-intervention).

• Number of Adverse Events/Serious Adverse Events Reported

  The total number and severity rating of all adverse events reported will be collated at the end of the study.

  Throughout the intervention period (2 weeks), which are weeks 2 and 3 for the intervention group.

• Number of Adverse Events/Serious Adverse Events Reported

  The total number and severity rating of all adverse events reported will be collated at the end of the study.

  Throughout the intervention period (2 weeks), which are weeks 5 and 6 for the waitlist control group.

Secondary Outcomes (5)

• Pittsburg Sleep Quality Index (PSQI)

  Intervention group: Changes from baseline sleep quality (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline sleep quality (week 1) to pre-intervention (week 4) and post-intervention (week 7).

• Insomnia Severity Index (ISI)

  Intervention group: Changes from baseline insomnia symptoms (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).

• Difficulties in Emotion Regulation Scale (DERS-SF)

  Intervention group: Changes from baseline emotional regulation (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).

• Mindfulness Awareness Attention Scale (MAAS)

  Intervention group: Changes from baseline mindfulness (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline mindfulness (week 1) to pre-intervention (week 4) and post-intervention (week 7).

• Depression Anxiety Stress Scale (DASS-21)

  Intervention group: Changes from baseline depression, anxiety and stress (week 1) to post-intervention (week 4) and follow-up (week 7). Waitlist control group: Changes from baseline (week 1) to pre-intervention (week 4) and post-intervention (week 7).

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will undergo a brief interactive psychoeducation session four times a week for two weeks. For each session, participants will wear a commercially available Electroencephalography (EEG) headset and play a downloaded online game for a total of 30 minutes. Participants can feel free to play the game for more than the instructed frequency during their 2-week intervention participation.

Device: Brain-Computer Interface

Waitlist control

NO INTERVENTION

Participants in Waitlist Control will receive no intervention in the first four weeks of the study. After the Intervention group has completed treatment, participants in the Waitlist Control will then undergo the same intervention as the Intervention group.

Interventions

Brain-Computer Interface DEVICE

Brain-computer Interface (BCI) is a direct communication pathway between a human brain and an external device. Electroencephalography (EEG) is the best studied non-invasive interface facilitating such communication. Our technology will deliver a mindfulness-based anxiety regulation intervention through a neuro-/ bio-feedback-based game interface that is driven by an EEG algorithm.

Intervention

Eligibility Criteria

• Age: 21 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Aged between 21 and 35 years old (inclusive).
• Literate in English.
• Computer literate and has access to a Windows 10 desktop or laptop
• Beck Anxiety Inventory II total score ≥ 16

You may not qualify if:

• Diagnosis (as defined by DSM-5) of: any anxiety disorder induced by medication, substance, or another medical condition; obsessive compulsive disorder; bipolar disorder; any psychotic disorder (lifetime); intellectual disability (i.e. IQ \< 70); autism spectrum disorder; attention-deficit/ hyperactivity disorder
• History of substance or drug use disorder (as per DSM-5 criteria) within the last 3 months
• Neurological disorders or insults (e.g. epilepsy, cerebrovascular accidents)
• Metal in the cranium, skull defects, or skin lesions on scalp (cuts, abrasions, rash) at proposed electrode sites
• Gross visual and hearing impairments
• Irregular heart rhythms or heart problems, severe visual or hearing impairment
• Prior experience with mindfulness-based therapy (e.g. mindfulness-based stress reduction \[MBSR\], mindfulness-based cognitive therapy \[MBCT\])

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead
• Nanyang Technological University: collaborator

Study Sites (1)

Duke-NUS Medical School

Singapore, 169857, Singapore

Location

MeSH Terms

Conditions

Anxiety Disorders

Interventions

Brain-Computer Interfaces

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Electrical Equipment and Supplies; Equipment and Supplies

Study Officials

• Tih Shih Lee, MD PHD

  Duke-NUS Graduate Medical School

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: November 12, 2020
• Study Start: January 5, 2021
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: November 17, 2021

Record last verified: 2021-11

Locations

SG (1)