Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000550707
Ethics application status
Not yet submitted
Date submitted
7/05/2013
Date registered
15/05/2013
Date last updated
22/05/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Positive Psychology and Acceptance and Commitment Therapy: The effectiveness of a combined program in improving student wellbeing.
Scientific title
Does a high school based Positive Psychology and Acceptance and Commitment Therapy Program increase wellbeing and improve mental health compared to a health classes as usual control group? A randomly controlled Trial.
Secondary ID [1] 282422 0
Nil
Universal Trial Number (UTN)
U1111-1142-4908
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mental health 289015 0
Depression 289016 0
Anxiety 289017 0
Wellbeing 289018 0
Condition category
Condition code
Mental Health 289355 289355 0 0
Depression
Mental Health 289356 289356 0 0
Anxiety
Mental Health 289357 289357 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Sixteen bi-weekly workshops of half an hour each, across an eight week period. Fifty percent of the presented material is from Positive Psychology and the other fifty percent from Acceptance and Commitment Therapy. The workshops are presented face-to-face with a facilitor. Presented material will be supported by group discussions, videos and internet-based exercises. Workshops will take place during students health classes. Classroom teachers will be present but will not aid in program delivery.

Material presented from Positive Psychology will be based on developing Hope, Mindfulness, and Meaning. The Acceptance and Commitment Training material will include Values, Accepting Negative Emotions and Thoughts, and Committed Action.

Students will complete questionnaires regarding their wellbeing and mental health before the workshops, at the end of the workshops, and 6-months and at 12-months follow-ups. As part of the follow-up assessments, students will be asked to report on the extent that they have utilised the strategies presented during the workshops.
Intervention code [1] 287058 0
Prevention
Intervention code [2] 287059 0
Behaviour
Intervention code [3] 287060 0
Lifestyle
Comparator / control treatment
Eight weeks of Personal Development, Health, and Personal Education (PDHPE) classes as usual. There are two classes per week, each of a half hour duration.

The PDHPE classes are led by school teachers and teach students skills in communication, decision-making, interacting, moving, planning, and problem-solving, in relation to their own self, their relationships, physical activity, and their health.
Control group
Active

Outcomes
Primary outcome [1] 289469 0
Preventing future cases of psychopathology, as assessed by the Strengths and Difficulties Questionnaire.
Timepoint [1] 289469 0
6-month and 12-month follow-ups
Secondary outcome [1] 302550 0
Improved wellbeing, as assessed by the Flourishing Scale.
Timepoint [1] 302550 0
Post-intervention (immediately after the final class or workshop), 6-month and at 12-month follow-ups
Secondary outcome [2] 302555 0
Reduced psychopathology, as assessed by the Strengths and Difficulties Questionnaire.
Timepoint [2] 302555 0
Post-intervention (immediately after the final class or workshop) and 6-month follow-up.

Eligibility
Key inclusion criteria
All year 10 and 11 students an Australian independent high school are included in the study
Minimum age
15 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Limited English proficiency as determined by the teacher and researcher.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Students will be randomly allocated by classes (between 20 and 25 per class) to either the control or experimental condition. Allocation will be blocked by year, ensuring equal numbers of year 10 and year 11 students in each condition. Participants and experimenters will be aware of which group receives the experimental condition (i.e. no blinding will occur).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Excel random number generator will be used for randomisation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
A series of MANOVAs will examine the effectiveness of the program.

Power analyses using G-Power were conducted to estimate the sample size needed to detect changes. Using a MANOVA to analysis results, an alpha level of 0.05, and a power level of 0.8, a sample size of 330 is required to detect a .25 effect size.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
31/07/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
330
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 6811 0
2000 - Sydney

Funding & Sponsors
Funding source category [1] 287197 0
Self funded/Unfunded
Name [1] 287197 0
Country [1] 287197 0
Primary sponsor type
Individual
Name
A/Professor Vijaya Manicavasagar
Address
Black Dog Institute
Hospital Rd
Randwick, 2031, NSW
Country
Australia
Secondary sponsor category [1] 285960 0
Individual
Name [1] 285960 0
Rowan Burckhardt
Address [1] 285960 0
Black Dog Institute
Hospital Rd,
Randwick, 2031, NSW
Country [1] 285960 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289190 0
University of NSW Human Research Ethics Committee
Ethics committee address [1] 289190 0
Ethics committee country [1] 289190 0
Australia
Date submitted for ethics approval [1] 289190 0
07/05/2013
Approval date [1] 289190 0
Ethics approval number [1] 289190 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 39686 0
A/Prof Vijaya Manicavasagar
Address 39686 0
Black Dog Institute
Hospital rd,
Randwick, 2031, NSW
Country 39686 0
Australia
Phone 39686 0
+61 2 9382 4320
Fax 39686 0
Email 39686 0
[email protected]
Contact person for public queries
Name 39687 0
Rowan Burckhardt
Address 39687 0
Black Dog Institute
Hospital rd,
Randwick, 2031, NSW
Country 39687 0
Australia
Phone 39687 0
+61 2 9382 9297
Fax 39687 0
Email 39687 0
[email protected]
Contact person for scientific queries
Name 39688 0
Rowan Burckhardt
Address 39688 0
Black Dog Institute
Hospital rd,
Randwick, 2031, NSW
Country 39688 0
Australia
Phone 39688 0
+61 2 9382 9297
Fax 39688 0
Email 39688 0
[email protected]

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
No additional documents have been identified.