Clinical trial NCT04333667: Effectiveness of Mindfulness-based Internet Intervention Still Me
Official title: Effectiveness of Mindfulness-based Internet Intervention Still Me: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Keywords: PTSD
mindfulness
efficacy
internet intervention
Lead sponsor: Vilnius University
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2020-04-03
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly allocated either to the intervention or control groups. The control group is a waiting list. The control group will participate in the intervention after it will be completed for the intervention group.
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change on International Trauma Questionnaire
timeFrame: Pre-treatment, after 8 weeks, 3 months post-treatment
Secondary outcomes:
measure: Change on Patient Health Questionnaire-9
timeFrame: Pre-treatment, after 8 weeks, 3 months post-treatment
measure: Change on General anxiety disorder
timeFrame: Pre-treatment, after 8 weeks, 3 months post-treatment
measure: Change on Adjustment disorder - New Module 8
timeFrame: Pre-treatment, after 8 weeks, 3 months post-treatment
measure: Change on Positive Mental Health Scale
timeFrame: Pre-treatment, after 8 weeks, 3 months post-treatment
measure: Change on Five Facet Mindfulness Questionnaire-Short form
timeFrame: Pre-treatment, after 8 weeks, 3 months post-treatment
Other outcomes:
Locations:
city: Vilnius
country: Lithuania
facility: Vilnius University
Study officials:
affiliation: Vilnius University
name: Evaldas Kazlauskas, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dumarkaite A, Truskauskaite-Kuneviciene I, Andersson G, Kazlauskas E. The Effects of Online Mindfulness-Based Intervention on Posttraumatic Stress Disorder and Complex Posttraumatic Stress Disorder Symptoms: A Randomized Controlled Trial With 3-Month Follow-Up. Front Psychiatry. 2022 Mar 30;13:799259. doi: 10.3389/fpsyt.2022.799259. eCollection 2022.