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Clinical Trials/NCT04333667
NCT04333667
Completed
Not Applicable

Effectiveness of Mindfulness-based Internet Intervention Still Me: a Randomized Controlled Trial

Vilnius University1 site in 1 country125 target enrollmentApril 14, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Post-traumatic Stress Disorder
Sponsor
Vilnius University
Enrollment
125
Locations
1
Primary Endpoint
Change on International Trauma Questionnaire
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
April 14, 2020
End Date
December 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Evaldas Kazlauskas

Professor

Vilnius University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Change on Patient Health Questionnaire-9(Pre-treatment, after 8 weeks, 3 months post-treatment)
  • Change on General anxiety disorder(Pre-treatment, after 8 weeks, 3 months post-treatment)
  • Change on Adjustment disorder - New Module 8(Pre-treatment, after 8 weeks, 3 months post-treatment)
  • Change on Positive Mental Health Scale(Pre-treatment, after 8 weeks, 3 months post-treatment)
  • Change on Five Facet Mindfulness Questionnaire-Short form(Pre-treatment, after 8 weeks, 3 months post-treatment)

Study Sites (1)

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