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Effectiveness of Mindfulness-based Internet Intervention Still Me (Still-Me)

Primary Purpose

Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Lithuania
Study Type
Interventional
Intervention
Intervention group
Sponsored by
Vilnius University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Post-traumatic Stress Disorder focused on measuring PTSD, mindfulness, efficacy, internet intervention

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Vilnius University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.

Full Information

First Posted
March 31, 2020
Last Updated
January 17, 2023
Sponsor
Vilnius University
Collaborators
Linkoeping University
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1. Study Identification

Unique Protocol Identification Number
NCT04333667
Brief Title
Effectiveness of Mindfulness-based Internet Intervention Still Me
Acronym
Still-Me
Official Title
Effectiveness of Mindfulness-based Internet Intervention Still Me: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
May 31, 2021 (Actual)
Study Completion Date
December 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vilnius University
Collaborators
Linkoeping University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-traumatic Stress Disorder
Keywords
PTSD, mindfulness, efficacy, internet intervention

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm Description
The intervention group will get an 8-week mindfulness-based internet intervention.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change on International Trauma Questionnaire
Description
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.
Time Frame
Pre-treatment, after 8 weeks, 3 months post-treatment
Secondary Outcome Measure Information:
Title
Change on Patient Health Questionnaire-9
Description
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.
Time Frame
Pre-treatment, after 8 weeks, 3 months post-treatment
Title
Change on General anxiety disorder
Description
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.
Time Frame
Pre-treatment, after 8 weeks, 3 months post-treatment
Title
Change on Adjustment disorder - New Module 8
Description
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.
Time Frame
Pre-treatment, after 8 weeks, 3 months post-treatment
Title
Change on Positive Mental Health Scale
Description
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.
Time Frame
Pre-treatment, after 8 weeks, 3 months post-treatment
Title
Change on Five Facet Mindfulness Questionnaire-Short form
Description
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.
Time Frame
Pre-treatment, after 8 weeks, 3 months post-treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evaldas Kazlauskas, Ph.D.
Organizational Affiliation
Vilnius University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vilnius University
City
Vilnius
Country
Lithuania

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35432020
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.
Results Reference
derived

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Effectiveness of Mindfulness-based Internet Intervention Still Me

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