Traumatic Stress DisorderNCT06419387
The Effect of Flash Technique Via Self-Therapy App on Depression, Anxiety, and Traumatic Symptoms
A study testing Self-Therapy Mobile App and Psycho-education Videos in people with Traumatic Stress Disorder, run by Academy of Therapeutic Sciences, Turkey at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Stress Disorder
- What is being tested?
- Self-Therapy Mobile App and Psycho-education Videos
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 1 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Being over the age of 18
- Having access to the internet
Who cannot join
- A diagnosis of psychotic illness
- Presence of mental retardation
- Moderate or severe depression
- Active suicidal thoughts
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Flash Technique Via Self-Therapy App on Depression, Anxiety, and Traumatic Symptoms in Individuals Who Have Experienced a Traffic Accident: A Randomized-Controlled Design
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.
Read the detailed description
EMDR is a psychotherapy method used in the treatment of psychological traumas. The Flash technique is considered one of the fastest and most effective techniques of EMDR. The self-therapy application allows users to apply the Flash technique by themselves by following guidelines, aiming to reduce depression, anxiety, and stress levels associated with traumatic memories. Applications like "Self-Therapy" could serve as an important model for the development and widespread adoption of remote psychological support services. With this project, individuals experiencing stressful life events could support their own healing process through a mobile application. This could lay the foundation for the development and expansion of similar mobile applications, thereby inspiring new projects and studies aimed at enhancing and increasing the accessibility of post-traumatic support services. The ease of access to psychotherapy through a mobile application could help increase societal awareness and acceptance of psychological health services.The "Self-Therapy" project is specifically designed for adults aged 18 and older who have experienced a traumatic or stressful event and perceive a decline in their quality of life due to its effects. The mobile application, available for download on both the Apple Store and Google Play, is primarily intended for individuals diagnosed with a mental health disorder, and it is recommended that they use the application under the guidance and recommendation of their psychiatrist.
The application employs a virtual guide, an avatar named Therapist Yağmur, who leads users through the program. Through the avatar's instructions, users engage in the Flash technique to actively address and work through their traumatic memories. Additionally, the application includes relaxation exercises that can be utilized as needed. Users are able to track their progress within the app, enabling them to pause and resume their therapeutic journey as required, thereby facilitating a self-directed approach to managing and potentially mitigating the impacts of their traumatic experiences.
- Conditions
- Traumatic Stress Disorder
- Being tested
- Self-Therapy Mobile App, Psycho-education Videos
- Keywords
- EMDR, Mobile App, Traumatic Stress
- Medical subject headings
- Stress Disorders, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-Therapy Mobile AppDevice
Self-Therapy Mobile App includes videos and guidelines for applying EMDR Flash Technique
Psycho-education VideosOther
Psycho-education Videos include guidelines for increasing emotion regulation skills.
| Study group | Role | What they receive |
|---|---|---|
| Self-Therapy App | Experimental | EMDR Flash Technique protocol will be administered via Self-Therapy App. Receives: Device: Self-Therapy Mobile App |
| Psycho-Education | Active comparator | Psycho-Education will be administered via videos of a psychology professor. Receives: Other: Psycho-education Videos |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 1-week and 1-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2024
- Study start1 Feb 2024
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Stress DisorderStudies 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
- EMDR Mobile App (Intervention) Group vs. Psycho-educational (Video) Control Group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academy of Therapeutic Sciences, Turkey
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06419387
- Sponsor's protocol ID
- TBA2024
- Status last verified
- May 2024
- First submitted
- 14 May 2024
- Last updated
- 20 May 2024
- 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 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Flash Technique Via Self-Therapy App on Depression, Anxiety, and Traumatic Symptoms in Individuals Who Have Experienced a Traffic Accident: A Randomized-Controlled Design
- ClinicalTrials.gov ID
- NCT06419387
- Acronym / sponsor ID
- TBA2024
- Conditions
- Traumatic Stress Disorder
- Keywords
- EMDR, Mobile App, Traumatic Stress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Academy of Therapeutic Sciences, TurkeyUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Jul 2024 (estimated)
- First posted
- 17 May 2024 (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.
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.
Detailed description
EMDR is a psychotherapy method used in the treatment of psychological traumas. The Flash technique is considered one of the fastest and most effective techniques of EMDR. The self-therapy application allows users to apply the Flash technique by themselves by following guidelines, aiming to reduce depression, anxiety, and stress levels associated with traumatic memories. Applications like "Self-Therapy" could serve as an important model for the development and widespread adoption of remote psychological support services. With this project, individuals experiencing stressful life events could support their own healing process through a mobile application. This could lay the foundation for the development and expansion of similar mobile applications, thereby inspiring new projects and studies aimed at enhancing and increasing the accessibility of post-traumatic support services. The ease of access to psychotherapy through a mobile application could help increase societal awareness and acceptance of psychological health services.The "Self-Therapy" project is specifically designed for adults aged 18 and older who have experienced a traumatic or stressful event and perceive a decline in their quality of life due to its effects. The mobile application, available for download on both the Apple Store and Google Play, is primarily intended for individuals diagnosed with a mental health disorder, and it is recommended that they use the application under the guidance and recommendation of their psychiatrist.
The application employs a virtual guide, an avatar named Therapist Yağmur, who leads users through the program. Through the avatar's instructions, users engage in the Flash technique to actively address and work through their traumatic memories. Additionally, the application includes relaxation exercises that can be utilized as needed. Users are able to track their progress within the app, enabling them to pause and resume their therapeutic journey as required, thereby facilitating a self-directed approach to managing and potentially mitigating the impacts of their traumatic experiences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- EMDR Mobile App (Intervention) Group vs. Psycho-educational (Video) Control Group
| Arm | Type | Receives |
|---|---|---|
| Self-Therapy App | Experimental | Device: Self-Therapy Mobile AppEMDR Flash Technique protocol will be administered via Self-Therapy App. |
| Psycho-Education | Active comparator | Other: Psycho-education VideosPsycho-Education will be administered via videos of a psychology professor. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Being over the age of 18
- Having access to the internet
Key exclusion criteria (4 listed)
- A diagnosis of psychotic illness
- Moderate or severe depression
- Active suicidal thoughts
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 |
|---|---|---|
| Self-Therapy Mobile AppSelf-Therapy Mobile App includes videos and guidelines for applying EMDR Flash Technique | Device | Self-Therapy App |
| Psycho-education VideosPsycho-education Videos include guidelines for increasing emotion regulation skills. | Other | Psycho-Education |
Primary outcome
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21)
Time frame: 1-week and 1-month follow-up
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
Impact of Events Scale Revised (IES-R)
Time frame: 1-week and 1-month follow-up
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-Therapy Mobile App and Psycho-education Videos in people with Traumatic Stress Disorder, run by Academy of Therapeutic Sciences, Turkey at 1 site in Turkey (Türkiye).
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) (time frame: 1-week and 1-month follow-up). The study lists 2 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 20 May 2024.