NCT06419387

Brief Summary

EMDR is a psychotherapy method utilized for treating psychological traumas, with the Flash technique being one of its quickest and most effective methods. The "Self-Therapy" mobile application, accessible via Apple Store and Google Play, enables users to self-administer the Flash technique, following specific guidelines to help reduce symptoms like depression, anxiety, and stress linked to traumatic memories. Designed for adults over 18, particularly those diagnosed with mental health disorders, it is advised to be used under a psychiatrist's guidance. The application features a virtual guide, an avatar named Therapist Yağmur, who assists users through the process, including relaxation exercises and progress tracking. This allows users to pause and resume therapy as needed. Such applications represent a significant advancement in remote psychological support, potentially increasing access to psychotherapy and fostering societal acceptance of psychological health services.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not 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

Study Start

First participant enrolled

February 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

May 20, 2024

Status Verified

May 1, 2024

Enrollment Period

5 months

First QC Date

May 14, 2024

Last Update Submit

May 17, 2024

Conditions

Keywords

EMDRMobile AppTraumatic Stress

Outcome Measures

Primary Outcomes (2)

  • The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)

    Depression, stress and anxiety scores will significantly change. Scores for depression, anxiety and stress are calculated by summing the scores. The scores are between 0-3, and more scores mean worse results. for the relevant items

    1-week and 1-month follow-up

  • Impact of Events Scale Revised (IES-R)

    Intrusion and hyperarousal scores will significantly change. The maximum mean score on each of the three subscales is '4', therefore the maximum 'total mean' IES- R score is 12. Lower scores are better.

    1-week and 1-month follow-up

Study Arms (2)

Self-Therapy App

EXPERIMENTAL

EMDR Flash Technique protocol will be administered via Self-Therapy App.

Device: Self-Therapy Mobile App

Psycho-Education

ACTIVE COMPARATOR

Psycho-Education will be administered via videos of a psychology professor.

Other: Psycho-education Videos

Interventions

Self-Therapy Mobile App includes videos and guidelines for applying EMDR Flash Technique

Self-Therapy App

Psycho-education Videos include guidelines for increasing emotion regulation skills.

Psycho-Education

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Being over the age of 18
  • Having access to the internet

You may not qualify if:

  • A diagnosis of psychotic illness
  • Presence of mental retardation
  • Moderate or severe depression
  • Active suicidal thoughts

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Academy of Therapeutic Sciences

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Stress Disorders, Traumatic

Condition Hierarchy (Ancestors)

Trauma and Stressor Related DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Single
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: EMDR Mobile App (Intervention) Group vs. Psycho-educational (Video) Control Group
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2024

First Posted

May 17, 2024

Study Start

February 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

May 20, 2024

Record last verified: 2024-05

Locations