Effectiveness of Mindfulness-based Internet Intervention Still Me

Post-traumatic Stress Disorder Clinical Trial

— Still-Me  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333667
• Other study ID #: 2020-02-27/36
• Status: Completed
• Phase: N/A
• Start date: April 14, 2020
• Est. completion date: December 31, 2022

Study information

• Verified date: January 2023
• Source: Vilnius University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: December 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Post-traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Intervention group
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.

Locations

Country	Name	City	State
Lithuania	Vilnius University	Vilnius

Sponsors (2)

Lead Sponsor	Collaborator
Vilnius University	Linkoeping University

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-treatment, after 8 weeks, 3 months post-treatment
Secondary	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.	Pre-treatment, after 8 weeks, 3 months post-treatment
Secondary	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.	Pre-treatment, after 8 weeks, 3 months post-treatment
Secondary	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.	Pre-treatment, after 8 weeks, 3 months post-treatment
Secondary	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.	Pre-treatment, after 8 weeks, 3 months post-treatment
Secondary	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.	Pre-treatment, after 8 weeks, 3 months post-treatment