Post-traumatic Stress DisorderStill-MeNCT04333667
Effectiveness of Mindfulness-based Internet Intervention Still Me
A study testing Intervention group in people with Post-traumatic Stress Disorder, run by Vilnius University at 1 site in Lithuania.
Trial summary
The aim of the study is to assess the effectiveness of a mindfulness-based internet intervention for post-traumatic stress disorder symptoms. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-traumatic Stress Disorder
- What is being tested?
- Intervention group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteLithuania
- Study dates
- 14 Apr 2020to 31 Dec 2022
- 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
- at least 18-years-old;
- understand Lithuanian;
- internet access and device for that;
- at least one traumatic event during lifetime;
- post-traumatic stress disorder symptoms.
Who cannot join
- an acute case of psychiatric care;
- interpersonal violence;
- alcohol / drug addiction;
- cannot participate.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Mindfulness-based Internet Intervention Still Me: a Randomized Controlled Trial
The aim of the study is to assess the effectiveness of a mindfulness-based internet intervention for post-traumatic stress disorder symptoms.
Read the detailed description
Intervention is going to take the form of a mindfulness-based internet intervention consisting of eight modules. The themes include awareness and nonjudgment of senses, emotions, and thoughts. These themes were chosen after considering topics that might be the most useful for individuals who experience post-traumatic disorder symptoms. Each module consists of psychoeducation and exercise (audio records mostly) parts. Psychologist can be reached on demand.
The effect of the intervention will be compared against a waiting list control group. Intervention is in Lithuanian.
- Conditions
- Post-traumatic Stress Disorder
- Being tested
- Intervention group
- Keywords
- PTSD, mindfulness, efficacy, internet intervention
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention groupBehavioural
The intervention consists of 8 modules. Each week participants get access to a new module. Each module consists of psychoeducation and exercise parts. Most of the exercises are based on audio records. The content of the modules includes such themes as awareness and nonjudgement of senses, emotions, and thoughts. Participants can reach a psychologist on demand.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | The intervention group will get an 8-week mindfulness-based internet intervention. Receives: Behavioral: Intervention group |
| Control group | No intervention | The waiting list will get no intervention while the intervention group is getting the intervention. The waiting list has the possibility to get an intervention after the intervention group finishes it. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change on International Trauma Questionnaire
Changes on post-traumatic stress disorder are measured. International Trauma Questionanaire (ITQ, Cloitre et al., 2018) is a self-report measure and consists of 18 questions. All items are answered on a 5-point Likert scale that ranges from 0 (not at all) to 4 (extremely). Higher score indicates more pronounced symptoms.
Measured: Pre-treatment, after 8 weeks, 3 months post-treatment
Secondary outcomes (5)
Change on Patient Health Questionnaire-9
Changes on depression symptoms are measured. Patient Health Questionnaire-9 (PHQ-9, Kroenke et al., 2001) is a self-report measure and consists of 9 questions. All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 3 (nearly every day). Higher score indicates more pronounced symptoms.
Measured: Pre-treatment, after 8 weeks, 3 months post-treatment
Change on General anxiety disorder
Changes on anxiety symptoms are measured. General Anxiety disorder (GAD-7, Spitzer, Kroenke, Williams, \& Löwe, 2006) is a self-report measure and consists of 7 items. All items are answered on a 4-point Likert scale that ranges from 0 (not at all) to 4 (nearly every day). Higher score indicates more pronounced symptoms.
Measured: Pre-treatment, after 8 weeks, 3 months post-treatment
Change on Adjustment disorder - New Module 8
Changes on adjustment disorder are measured. Adjustment disorder - New Module 8 (ADNM-8, Kazlauskas et al., 2018) is a self-report measure comprised of two parts: the stressor list, and the symptom list. The symptom list answers are answered on a 4-point Likert scale that ranges from 1 (never) to 4 (often).Higher score indicates more pronounced symptoms.
Measured: Pre-treatment, after 8 weeks, 3 months post-treatment
Change on Positive Mental Health Scale
Chages on positive mental health are measured. Positive Mental Health Scale (PMH, Lukat et al., 2016) is a self-report measure and consists of 9 questions. All items are answered on a 4-point Likert scale that ranges from 0 (do not agree) to 3 (agree). Higher score indicates more pronounced positive mental health.
Measured: Pre-treatment, after 8 weeks, 3 months post-treatment
Change on Five Facet Mindfulness Questionnaire-Short form
Changes on mindfulness skills are measured. Five Facet Mindfulness Questionnaire-Short form (FFMQ-SF, Bohlmeijer et al., 2011) is a self-report measure and consists of 24 items. All items are answered on a 4-point Likert scale that ranges from 1 (never or very rarely true) to 5 (very often or always true). Higher score indicates more pronounced mindfulness skills.
Measured: Pre-treatment, after 8 weeks, 3 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start14 Apr 2020
- Primary completion31 May 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-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
- Participants will be randomly allocated either to the intervention or control groups. The control group is a waiting list. The control group will participate in the intervention after it will be completed for the intervention group.
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vilnius University
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Evaldas Kazlauskas, Vilnius University
- Investigators
- Evaldas Kazlauskas, Ph.D., Principal investigator, Vilnius University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333667
- Sponsor's protocol ID
- 2020-02-27/36
- Acronym
- Still-Me
- Status last verified
- Jan 2023
- First submitted
- 31 Mar 2020
- Last updated
- 18 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dumarkaite A, Truskauskaite-Kuneviciene I, Andersson G, Kazlauskas E. The Effects of Online Mindfulness-Based Intervention on Posttraumatic Stress Disorder and Complex Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial With 3-Month Follow-Up. Front Psychiatry. 2022 Mar 30;13:799259. doi: 10.3389/fpsyt.2022.799259. eCollection 2022.
PubMed 35432020
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Mindfulness-based Internet Intervention Still Me: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04333667
- Acronym / sponsor ID
- Still-Me / 2020-02-27/36
- Conditions
- Post-traumatic Stress Disorder
- Keywords
- PTSD, mindfulness, efficacy, internet intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- Vilnius UniversityUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 14 Apr 2020 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 3 Apr 2020 (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 aim of the study is to assess the effectiveness of a mindfulness-based internet intervention for post-traumatic stress disorder symptoms.
Detailed description
Intervention is going to take the form of a mindfulness-based internet intervention consisting of eight modules. The themes include awareness and nonjudgment of senses, emotions, and thoughts. These themes were chosen after considering topics that might be the most useful for individuals who experience post-traumatic disorder symptoms. Each module consists of psychoeducation and exercise (audio records mostly) parts. Psychologist can be reached on demand.
The effect of the intervention will be compared against a waiting list control group. Intervention is in Lithuanian.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated either to the intervention or control groups. The control group is a waiting list. The control group will participate in the intervention after it will be completed for the intervention group.
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Behavioral: Intervention groupThe intervention group will get an 8-week mindfulness-based internet intervention. |
| Control group | No intervention | –The waiting list will get no intervention while the intervention group is getting the intervention. The waiting list has the possibility to get an intervention after the intervention group finishes it. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- at least 18-years-old;
- understand Lithuanian;
- internet access and device for that;
- at least one traumatic event during lifetime;
- post-traumatic stress disorder symptoms.
Key exclusion criteria (4 listed)
- an acute case of psychiatric care;
- interpersonal violence;
- alcohol / drug addiction;
- cannot participate.
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 groupThe intervention consists of 8 modules. Each week participants get access to a new module. Each module consists of psychoeducation and exercise parts. Most of the exercises are based on audio records. The content of the modules includes such themes as awareness and nonjudgement of senses, emotions, and thoughts. Participants can reach a psychologist on demand. | Behavioural | Intervention group |
Primary outcome
Change on International Trauma Questionnaire
Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment
Changes on post-traumatic stress disorder are measured. International Trauma Questionanaire (ITQ, Cloitre et al., 2018) is a self-report measure and consists of 18 questions. All items are answered on a 5-point Likert scale that ranges from 0 (not at all) to 4 (extremely). Higher score indicates more pronounced symptoms.
5 secondary outcomes
Change on Patient Health Questionnaire-9
Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment
Change on General anxiety disorder
Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment
Change on Adjustment disorder - New Module 8
Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment
Change on Positive Mental Health Scale
Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment
Change on Five Facet Mindfulness Questionnaire-Short form
Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2023.
- Derived from this study: PubMed 35432020Dumarkaite A, Truskauskaite-Kuneviciene I, Andersson G, Kazlauskas E. The Effects of Online Mindfulness-Based Intervention on Posttraumatic Stress Disorder and Complex Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial With 3-Month Follow-Up. Front Psychiatry. 2022 Mar 30;13:799259. doi: 10.3389/fpsyt.2022.799259. eCollection 2022.
- Individual participant dataSharing planned: No
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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.
Evaldas Kazlauskas, Ph.D. principal investigator
Vilnius University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group in people with Post-traumatic Stress Disorder, run by Vilnius University at 1 site in Lithuania.
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 5 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: finished, as of the sponsor's last update on 18 Jan 2023. 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 Lithuania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change on International Trauma Questionnaire (time frame: Pre-treatment, after 8 weeks, 3 months post-treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333667, which also lists 1 linked publication.
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 18 Jan 2023.