- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04333667
Effectiveness of Mindfulness-based Internet Intervention Still Me (Still-Me)
Effectiveness of Mindfulness-based Internet Intervention Still Me: a Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Vilnius, Lithuania
- Vilnius University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- an acute case of psychiatric care;
- interpersonal violence;
- alcohol / drug addiction;
- cannot participate.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention group
The intervention group will get an 8-week mindfulness-based internet intervention.
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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.
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No Intervention: Control group
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on International Trauma Questionnaire
Time Frame: Pre-treatment, after 8 weeks, 3 months post-treatment
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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.
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Pre-treatment, after 8 weeks, 3 months post-treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change on Patient Health Questionnaire-9
Time Frame: Pre-treatment, after 8 weeks, 3 months post-treatment
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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.
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Pre-treatment, after 8 weeks, 3 months post-treatment
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Change on General anxiety disorder
Time Frame: Pre-treatment, after 8 weeks, 3 months post-treatment
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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.
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Pre-treatment, after 8 weeks, 3 months post-treatment
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Change on Adjustment disorder - New Module 8
Time Frame: Pre-treatment, after 8 weeks, 3 months post-treatment
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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.
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Pre-treatment, after 8 weeks, 3 months post-treatment
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Change on Positive Mental Health Scale
Time Frame: Pre-treatment, after 8 weeks, 3 months post-treatment
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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.
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Pre-treatment, after 8 weeks, 3 months post-treatment
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Change on Five Facet Mindfulness Questionnaire-Short form
Time Frame: Pre-treatment, after 8 weeks, 3 months post-treatment
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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.
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Pre-treatment, after 8 weeks, 3 months post-treatment
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Evaldas Kazlauskas, Ph.D., Vilnius University
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020-02-27/36
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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