Still-Me: Effectiveness of Mindfulness-based Internet Intervention Still Me

Sponsor
Vilnius University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04333667
Collaborator
Linkoeping University (Other)
300
1
2
39.6
7.6

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention group
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
300 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effectiveness of Mindfulness-based Internet Intervention Still Me: a Randomized Controlled Trial
Actual Study Start Date :
Apr 14, 2020
Actual Primary Completion Date :
May 31, 2021
Anticipated Study Completion Date :
Aug 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Intervention group

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

No Intervention: Control group

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vilnius University Vilnius Lithuania

Sponsors and Collaborators

  • Vilnius University
  • Linkoeping University

Investigators

  • Principal Investigator: Evaldas Kazlauskas, Ph.D., Vilnius University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Evaldas Kazlauskas, Professor, Vilnius University
ClinicalTrials.gov Identifier:
NCT04333667
Other Study ID Numbers:
  • 2020-02-27/36
First Posted:
Apr 3, 2020
Last Update Posted:
Oct 8, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Evaldas Kazlauskas, Professor, Vilnius University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 8, 2021