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Completed

NCT Number: NCT04333667

Effectiveness of Mindfulness-based Internet Intervention Still Me

The aim of the study is to assess the effectiveness of a mindfulness-based internet intervention for post-traumatic stress disorder symptoms.

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Key information

Conditions

Post-traumatic Stress Disorder Mental Disorders Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vilnius University

Vilnius, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intervention Group

Behavioral

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.

Primary outcomes

  1. 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

  1. Change on Patient Health Questionnaire-9

    Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment

    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.

  2. Change on General anxiety disorder

    Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment

    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.

  3. Change on Adjustment disorder - New Module 8

    Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment

    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.

  4. Change on Positive Mental Health Scale

    Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment

    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.

  5. Change on Five Facet Mindfulness Questionnaire-Short form

    Time frame: Pre-treatment, after 8 weeks, 3 months post-treatment

    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.

Sponsors and collaborators

Lead sponsor

Vilnius University

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

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

Acronym: Still-Me

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 3, 2020
Registry last updated
Jan 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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