Effectiveness of Mindfulness-based Internet Intervention Still Me

Not Applicable

Completed

• Conditions: Post-traumatic Stress Disorder
• Interventions: Behavioral: Intervention group

• Registration Number: NCT04333667
• Lead Sponsor: Vilnius University

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.

Study Timeline

• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-04-02
• Study First Posted: 2020-04-03
• Study Start: 2020-04-14
• Primary Completion: 2021-05-31
• Study Completion: 2022-12-31
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-17
• Last Update Posted: 2023-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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.

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Exclusion Criteria

• an acute case of psychiatric care;
• interpersonal violence;
• alcohol / drug addiction;
• cannot participate.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Intervention group	The intervention group will get an 8-week mindfulness-based internet intervention.

Primary Outcome Measures

Name	Time	Method
Change on International Trauma Questionnaire	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 Outcome Measures

Name	Time	Method
Change on Patient Health Questionnaire-9	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.
Change on General anxiety disorder	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.
Change on Adjustment disorder - New Module 8	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.
Change on Positive Mental Health Scale	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.
Change on Five Facet Mindfulness Questionnaire-Short form	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.

Trial Locations

Locations (1)

Vilnius University; 🇱🇹 Vilnius, Lithuania