Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000883415
Ethics application status
Approved
Date submitted
3/06/2016
Date registered
5/07/2016
Date last updated
11/05/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Brief Adjustment Disorder Intervention (BADI): evaluating internet-based modular program
Scientific title
Brief Adjustment Disorder Intervention (BADI): a randomized controlled trial evaluating internet-based modular program for adjustment disorder
Secondary ID [1] 289357 0
None
Universal Trial Number (UTN)
U1111-1183-7634
Trial acronym
BADI
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Adjustment disorder 298989 0
Condition category
Condition code
Mental Health 299052 299052 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 294941 0
Behaviour
Intervention code [2] 295161 0
Treatment: Other
Comparator / control treatment
Waiting-list control group. Participants allocated to the waiting-list control group will be able to use the intervention for one month after completing the second assessment after one month of waiting.
Control group
Active

Outcomes
Primary outcome [1] 298527 0
Adjustment disorder symptoms severity. Assessed with Adjustment Disorder New Module (ADNM).
Timepoint [1] 298527 0
At baseline (T1) and after one month of using BADI (T2).
Primary outcome [2] 298528 0
Psychological well-being. Assessed with WHO-5 Well-being index.
Timepoint [2] 298528 0
At baseline (T1) and after one month of using BADI (T2).
Secondary outcome [1] 324462 0
Motivation for change. Assessed using questionnaire designed for this trial
Timepoint [1] 324462 0
At baseline (T1) and after one month of using BADI (T2).
Secondary outcome [2] 324470 0
Expectations for intervention outcomes. Assessed using questionnaire designed for this trial.
Timepoint [2] 324470 0
At baseline (T1) and after one month of using BADI (T2).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Risk of suicide, severe adjustment difficulties.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation concealment acquired by using a study technician and randomization using random number generator (www.random.org).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Each participant after completing the baseline assessment is randomized to one of the intervention groups within 24 hours using a random number generator (www.random.org). No stratification is applied.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To achieve an improvement of 10 in mean scores of WHO-5 Well-being index we calculated about 73 participants per study arm to achieve 80% power at a=.05. Factoring in the 30% attrition rate, we seek to randomize a total of 190 participants. Cohens' d will be used to measure effect sizes. Repeated measures ANOVA will be used to determine statistically significant differences within and between groups.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/02/2016
Date of last participant enrolment
Anticipated
1/06/2017
Actual
5/06/2017
Date of last data collection
Anticipated
30/10/2017
Actual
30/10/2017
Sample size
Target
190
Accrual to date
Final
649
Recruitment outside Australia
Country [1] 7936 0
Lithuania
State/province [1] 7936 0

Funding & Sponsors
Funding source category [1] 293740 0
Government body
Name [1] 293740 0
Research Council of Lithuania
Country [1] 293740 0
Lithuania
Primary sponsor type
Individual
Name
Paulius Skruibis
Address
Associate professor, Vilnius University, Universiteto 9, Vilnius 01122
Country
Lithuania
Secondary sponsor category [1] 292569 0
None
Name [1] 292569 0
Address [1] 292569 0
Country [1] 292569 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295177 0
Vilnius University Psychology Research Ethics Comittee
Ethics committee address [1] 295177 0
Ethics committee country [1] 295177 0
Date submitted for ethics approval [1] 295177 0
Approval date [1] 295177 0
22/01/2016
Ethics approval number [1] 295177 0

Summary
Brief summary
The efficacy of internet-based interventions for various mental health problems has already been demonstrated. Many of these interventions still use a lot of human resources for delivery and assessment. Vilnius University Trauma research group has created an internet-based modular self-help intervention based on the principles of CBT and mindfulness for people with adjustment difficulties. The purpose of this trial is to evaluate BADI efficacy on adjustment disorder symptoms and psychological well-being compared to a waiting-list control group.
Trial website
www.badi.lt
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 66386 0
A/Prof Paulius Skruibis
Address 66386 0
Vilnius University, Universiteto 9, Vilnius 01122
Country 66386 0
Lithuania
Phone 66386 0
+37052687126
Fax 66386 0
Email 66386 0
paulius.skruibis@fsf.vu.lt
Contact person for public queries
Name 66387 0
Mr Jonas Eimontas
Address 66387 0
Vilnius University, Universiteto 9, Vilnius 01122
Country 66387 0
Lithuania
Phone 66387 0
+37052687126
Fax 66387 0
Email 66387 0
jonas.eimontas@fsf.vu.lt
Contact person for scientific queries
Name 66388 0
Mr Jonas Eimontas
Address 66388 0
Vilnius University, Universiteto 9, Vilnius 01122
Country 66388 0
Lithuania
Phone 66388 0
+37052687126
Fax 66388 0
Email 66388 0
jonas.eimontas@fsf.vu.lt

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseInternet-based modular program BADI for adjustment disorder: Protocol of a randomized controlled trial.2016https://dx.doi.org/10.1186/s12888-016-0980-9
N.B. These documents automatically identified may not have been verified by the study sponsor.