Effectiveness of Mindfulness-based Internet Intervention Still Me

NCT ID: NCT04333667

Last Updated: 2023-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

125 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-14

Study Completion Date

2022-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Post-traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Intervention group

Intervention Type BEHAVIORAL

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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Vilnius University

OTHER

Sponsor Role lead

Responsible Party

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Evaldas Kazlauskas

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evaldas Kazlauskas, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Vilnius University

Locations

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Vilnius University

Vilnius, , Lithuania

Site Status

Countries

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Lithuania

References

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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.

Reference Type DERIVED
PMID: 35432020 (View on PubMed)

Other Identifiers

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2020-02-27/36

Identifier Type: -

Identifier Source: org_study_id

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