NCT04333667

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 31, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 3, 2020

Completed
11 days until next milestone

Study Start

First participant enrolled

April 14, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2021

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

January 18, 2023

Status Verified

January 1, 2023

Enrollment Period

1.1 years

First QC Date

March 31, 2020

Last Update Submit

January 17, 2023

Conditions

Post-traumatic Stress Disorder

Keywords

PTSDmindfulnessefficacyinternet intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • 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 Arms (2)

Intervention group

EXPERIMENTAL

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

Behavioral: Intervention group

Control group

NO INTERVENTION

The waiting list will get no intervention while the intervention group is getting the intervention. The waiting list has the possibility to get an intervention after the intervention group finishes it.

Interventions

Intervention groupBEHAVIORAL

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University

Vilnius, Lithuania

Location

Related Publications (1)

  • 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.

    PMID: 35432020DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Evaldas Kazlauskas, Ph.D.

    Vilnius University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 31, 2020

First Posted

April 3, 2020

Study Start

April 14, 2020

Primary Completion

May 31, 2021

Study Completion

December 31, 2022

Last Updated

January 18, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

LI(1)