Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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13 January 2020 |
Main ID: |
ACTRN12616000883415 |
Date of registration:
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05/07/2016 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Brief Adjustment Disorder Intervention (BADI): evaluating internet-based modular program
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Scientific title:
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Brief Adjustment Disorder Intervention (BADI): a randomized controlled trial evaluating internet-based modular program for adjustment disorder
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Date of first enrolment:
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01/02/2016 |
Target sample size:
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190 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12616000883415.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;
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Phase:
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Not Applicable
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Countries of recruitment
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Lithuania
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Contacts
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Name:
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Mr Jonas Eimontas
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Address:
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Vilnius University, Universiteto 9, Vilnius 01122
Lithuania |
Telephone:
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+37052687126 |
Email:
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jonas.eimontas@fsf.vu.lt |
Affiliation:
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Name:
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Mr Jonas Eimontas
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Address:
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Vilnius University, Universiteto 9, Vilnius 01122
Lithuania |
Telephone:
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+37052687126 |
Email:
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jonas.eimontas@fsf.vu.lt |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All individuals willing to participate in the study have to have adjustment difficulties and be no less than of 18 years old, have access to internet and a computer or other smart gadget with screen and audio output, and have sufficient Lithuanian language literacy to understand the instructions and give informed consent. Adjustment difficulties are assessed with ADNM and WHO-5. Participants who score <50 on WHO-5, and > 16 on ADNM are included into the study.
Exclusion criteria: Risk of suicide, severe adjustment difficulties.
Age minimum:
18 Years
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Adjustment disorder; Adjustment disorder
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Mental Health - Other mental health disorders
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Intervention(s)
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BADI (Brief adjustment disorder intervention) is an internet-based modular self-help intervention for adjustment difficulties. BADI is designed as a self-help intervention delivered entirely via internet with no therapist support. It is based on the principles of CBT and mindfulness and consists of 4 modules: Relaxation exercises (Body module), Time management exercises (Time module), Mindfulness based exercises (Space module) and Exercises for strengthening relationships (Relationships module). Each module consists of 3 exercises which participants of the program are instructed to use based on their preference and as frequently as they feel the need. Exercises take from 3 to 7 minutes to complete. The participant may complete as many or as few modules as they choose. This enables a participant to personalize the intervention to his needs. The participants are instructed that they will have access to BADI for one month. Adherence will be measured by logging the completed exercises.
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Primary Outcome(s)
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Adjustment disorder symptoms severity. Assessed with Adjustment Disorder New Module (ADNM).[At baseline (T1) and after one month of using BADI (T2).]
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Psychological well-being. Assessed with WHO-5 Well-being index.[At baseline (T1) and after one month of using BADI (T2).]
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Secondary Outcome(s)
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Motivation for change. Assessed using questionnaire designed for this trial[At baseline (T1) and after one month of using BADI (T2).]
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Expectations for intervention outcomes. Assessed using questionnaire designed for this trial.[At baseline (T1) and after one month of using BADI (T2).]
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Source(s) of Monetary Support
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Research Council of Lithuania
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Ethics review
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Status: Approved
Approval date:
Contact:
Vilnius University Psychology Research Ethics Comittee
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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