Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617001451392
Ethics application status
Approved
Date submitted
9/10/2017
Date registered
12/10/2017
Date last updated
15/06/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Grit Wellbeing program for individuals attending residential rehabilitation for substance use problems.
Scientific title
A cohort analytic trial to determine whether the Grit Wellbeing program in combination with standard residential rehabilitation for substance use problems enhances wellbeing, resilience and social engagement, and reduces substance use and mental ill-health, compared to standard residential rehabilitation treatment alone.
Secondary ID [1] 293098 0
Nil
Universal Trial Number (UTN)
U1111-1203-4258
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Emotional Wellbeing 305034 0
Social Engagement 305037 0
Substance Use 305038 0
Condition category
Condition code
Mental Health 304364 304364 0 0
Addiction
Mental Health 304365 304365 0 0
Depression
Mental Health 304366 304366 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The Grit program + the standard residential rehabiliation recovery six week program. Participants in the Grit program will receive 2 program sessions per week, delivered in a group setting, over the course of 6 weeks alongside standard residential treatment. The 12 x 50 minute Grit sessions are detailed below. The program will delivered by a clinical researcher, with a minimum of provisional registration in psychology and training in clinical psychology, and LLW staff who have been trained in the program.

The Grit Wellbeing Program incorporates key elements of strengths-based mindfulness and Rock and Water psychosocial competency training to increase the social, emotional, psychological, and physical wellbeing of young people and decrease their risk of adverse outcomes.

Session 1: The program begins by explaining the mind-body connection, and how to breathe, ground and centre. Youtube videos are used to demonstrate breathing techniques, and the participants are invited to practice belly breathing. Grounding is then taught using a series of exercises focusing on balancing and anchoring oneself to the ground. Breathing and grounding techniques are then practiced in combination. Finally, participants are taught how to centre themselves by activating their core muscles using simple tensing and stretching exercises. These activities are conducted in a circle, individually, and in pairs.

Session 2: This session will be directed towards the final component - focusing, through an extended focus on breathing and on being mindful. The session begins revising the previous session, and revisiting belly breathing in particular. Mindfulness is then introduced using a short video to explain the often rapid activity of our mind. Simple mindful activities are then introduced, to increase participants awareness of how their mind wanders and how to breathe, ground, centre and focus. Focus activities include a mindful check-in, mindful eating (e.g., popping candy or chocolate), mindful boxing (with boxing gloves and mitts), and/or Chinese boxing (hand exercise). The session concludes with a 10 minute mindful breathing audio track.

Session 3. This session focuses on social identity and support, first focusing on the benefits of social support and its importance, identifying types of social groups that we belong to and their importance, followed by a task where clients map out their social world, visibly displaying their social connections, the importance of these connections, and links between their various social groups.

Session 4: This session focuses on character strengths. It begins with an exercise to revise teachings on breathing, grounding, centering and focusing, followed by team based exercises - to draw upon and highlight strengths. Participants complete a character strengths survey. Participants learn how to identify their own strengths, while also identifying the strengths of others in their group (using exercises to strength spotting and strength feedback). The session concludes with some breathe, ground, centre, focus exercises (tag, boxing, or shooting hoops - boxing gloves and mitts/basketball required).

Session 5: This session focuses on social wellbeing. Beginning with a refocus on breathing, grounding, centring and focusing, and a mindful check-in. Social games are then integrated with discussions on compatability and loss, as well as barriers to obtaining social support. Ways to give and receive support is then explored, with a re-emphasis on strengths, and how ones strengths can be used to enhance social connection.

Session 6: This session focuses on identity and values. Beginning with a refresh of breath, ground, centre and focus, clients then begin activities mapping out their various roles, interests, and traits; followed by values based activities, mapping out their ideals and values, and steps that can be taken to move towards these ideals.

Session 7: This session focuses on communication. Beginning with a practical activity to demonstrate the difference between cooperative versus competitive engagement, the session then moves into an exploration of aggressive, passive and assertive communication styles, with role plays and practical demonstrations, as well as tips for how to communicate more assertively. on social and emotional wellbeing. This session as focuses on boundaries, active listening, and the importance of body language.

Session 8. It begins with a strength spotting exercise, followed by a mindful check-in. The session then focuses how to identify emotions and ways to increase positive emotions using music. The music and mood posters of the key components, are used to facilitate this process. Practical demonstrations will follow of how to identify emotions, and how music can enhance positive emotions (speaker) – and how they can be enhanced by breathing, grounding, centering and focusing when listening to music, and other pleasant events that can be used to enhance positive emotions..

Session 9: This session focuses on emotional wellbeing. It begins with a strength spotting and breathing, grounding, centering and focusing exercise, followed by a mindful-check in using music. This session focuses on negative emotions, factors that can lead to negative emotions, and strategies that can alleviate negative emotions (e.g., exercise, spending time with friends, music). Practical exercises focused on how different types of music make participants feel, and how they could use music to improve a negative mood - through mood mapping. Exercise mapping is introduced as another way to gradually shift or alter one's mood.

Session 10: Focuses on managing thoughts and cravings. It begins with a revision of core components (breath, ground, centre, focus; strength spotting) and then a Chinese boxing exercise. There is a discussion about thoughts, a quiz to distinguish thoughts from facts, strategies to identify unhelpful thoughts, followed by meditative techniques to mange thoughts. Urge surfing is also introduced as a method to manage cravings.

Session 11: Focusing on Healthy me. It incorporates physical activities to highlight the benefits of physical exercise, which is followed by discussions on the current physical exercise guidelines, and ways to incorporate physical exercise into daily living. Sleep and diet is similarly explored, examining recommendations, and practical ways to improve sleep and diet habits.

Session 12. This session continues to revise key components from earlier sessions, with a specific focus on checking-in during difficult moments, identifying instances when clients are likely to be most vulnerable (i.e., HALT - Hungry, Angry, Lonely, Tired), and ways to manage these situations. Goals towards future recovery plans are developed. This session concludes with a recap on participants personal strengths and achievements through the program.

Participants receive handouts to remind them of the key exercises from each session, and develop goals at the end of each session to implement throughout the following week.
Intervention code [1] 299337 0
Treatment: Other
Intervention code [2] 299342 0
Behaviour
Comparator / control treatment
The standard residential rehabilitation six week program is also offered at Logan House, another residential rehabilitation facility. Clients entering this facility will act as the control group. Individuals who enrol in the six-week recovery program are provided with tailored support which aims to give them the tools to overcome their substance addiction. This standard care aims to provide participants with greater self-awareness, goal setting abilities, greater confidence, interpersonal skills and positive life strategies to help manage later challenges. This program is delivered by Lives Lived Well staff, many of whom are AOD workers, counsellors and social workers.
Control group
Active

Outcomes
Primary outcome [1] 303610 0
Level of Wellbeing (Mental Health Continuum - Short Form)
Timepoint [1] 303610 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline.
Primary outcome [2] 303611 0
Level of substance use and related problems through a composite score (WHO ASSIST)
Timepoint [2] 303611 0
Baseline compared to 3 (primary time point), 6, and 12 months post baseline.
Primary outcome [3] 303612 0
Level of engagement in education, training or employment (composite score from 2-items from the Australian Outcome Treatment Profile)
Timepoint [3] 303612 0
Baseline compared to 3 (primary timepoint), 6, and 12 months post baseline.
Secondary outcome [1] 339613 0
Mental health assessed using Patient Health Questionnaire (PHQ-9),
Timepoint [1] 339613 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline.
Secondary outcome [2] 339614 0
Multiple-Identity Scale.
Timepoint [2] 339614 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline
Secondary outcome [3] 339615 0
Physical health ( 7 day Adolescent Physical Activity Recall Questionnaire (APARQ)
Timepoint [3] 339615 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline.
Secondary outcome [4] 339616 0
Sense of Belonging Index (SOBI).
Timepoint [4] 339616 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline
Secondary outcome [5] 339617 0
5 Facet Mindfulness Questionnaire: Short Form (FFMQ-SF).
Timepoint [5] 339617 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline
Secondary outcome [6] 339620 0
Substance Use Recovery Evaluator (SURE).
Timepoint [6] 339620 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline
Secondary outcome [7] 339621 0
Client Satisfaction with treatment (Patient Experiences Questionnaire )
Timepoint [7] 339621 0
Post treatment 6 weeks (primary timepoint),
Secondary outcome [8] 339679 0
Mental illness (Generalised Anxiety Disorder 7 (GAD-7) )
Timepoint [8] 339679 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline.
Secondary outcome [9] 339681 0
Work and Social Adjustment (Work and Social Adjustment Scale)
Timepoint [9] 339681 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline.
Secondary outcome [10] 348222 0
Opiod treamtment Index - Use of Primary and Secondary Drug (quantity last three occassions) in the past month.
Timepoint [10] 348222 0
Baseline compared to 6 weeks (primary timepoint), 3, 6, and 12 months post baseline

Eligibility
Key inclusion criteria
Participants will include adults aged between 18 and 35 years, who have an alcohol or other drug dependence and are attending residential treatment at the Mirikai or Logan House residential facilities.
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Insufficient English to give informed consent (assessed by case manager on referral or by the research team during screening)
- Severe mental illness or intellectual disability that precludes the ability to consent (determined from case manager knowledge of the participant and based on observation of apparent cognitive capacity during consent call)

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There will no longer be any randomization
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
The other design features stated above no longer apply. There will be a continually rolling open 6 week program, between the two sites, with a minimum of three waves of six weeks for both Mirikai and Logan.
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
Sample allocation is restricted by the group size. With approx. 15 participants per residential program it as anticipated to have a least 45 participants per condition (with 90 participants in total).

. Outcome success will be determined by examining the significant difference in scores (p < .05), for key primary outcomes (i.e., wellbeing, mindfulness, educational/vocational engagement, substance use, depression, anxiety) from baseline to each of the follow-up points, as well as whether the effect size is small (0.2), moderate (0.5) and strong (0.8) depending on the value of cohen’s d. To determine whether the GRIT program is more efficacious than standard treatment, significant time x group interactions will be for each of the key outcome variables, as well as cohen’s d effect sizes.

Treatment condition will be an independent variable with two levels: (i) standard treatment (ii) standard treatment + Grit. Preliminary logistic regressions will be undertaken to check for baseline group differences on demographic, primary and secondary outcomes. A similar analysis will be conducted to detect differences between those with missing data, and those without, on key baseline demographic and outcome variables. Any significant differences will be reported and controlled for wherever possible, to control for sampling bias and completion bias. To determine whether there are group differences in improvements in primary and secondary outcomes of young people at post treatment (6 weeks), 3, 6, and 12 months follow up compared to baseline, a series of mixed effects model repeated measures analyses of variance (MMRM) will be employed. The within groups factor will be time (pre/post treatment, 3, 6, 12 months) and group will be the between subjects factor. This technique can also control for potential confounds (e.g. demographic characteristics, baseline emotion regulation), and for the clustering effects at the wave level. Intent to treat analyses will be performed, with all participants included in analyses, regardless of whether they withdraw from the treatment program, or did not complete all follow-up assessments.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/01/2018
Actual
30/04/2018
Date of last participant enrolment
Anticipated
1/01/2019
Actual
Date of last data collection
Anticipated
30/06/2020
Actual
Sample size
Target
90
Accrual to date
43
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 297724 0
Government body
Name [1] 297724 0
Australian Government Department of Health
Country [1] 297724 0
Australia
Primary sponsor type
University
Name
University of Queensland
Address
School of Psychology
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Australia
Country
Australia
Secondary sponsor category [1] 296770 0
None
Name [1] 296770 0
Address [1] 296770 0
Country [1] 296770 0
Other collaborator category [1] 279763 0
Other
Name [1] 279763 0
Lives Lived Well
Address [1] 279763 0
Level 1/Boundary Court,
55 Little Edward Street,
Spring Hill, Brisbane.
Country [1] 279763 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298792 0
The University of Queensland
Ethics committee address [1] 298792 0
Ethics committee country [1] 298792 0
Australia
Date submitted for ethics approval [1] 298792 0
10/10/2017
Approval date [1] 298792 0
06/04/2018
Ethics approval number [1] 298792 0
2017001524

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

Contacts
Principal investigator
Name 47314 0
Prof Leanne Hides
Address 47314 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 47314 0
Australia
Phone 47314 0
+61406185750
Fax 47314 0
Email 47314 0
[email protected]
Contact person for public queries
Name 47315 0
Leanne Hides
Address 47315 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 47315 0
Australia
Phone 47315 0
+61406185750
Fax 47315 0
Email 47315 0
[email protected]
Contact person for scientific queries
Name 47316 0
Leanne Hides
Address 47316 0
McElwain Building
The University of Queensland
St Lucia, QLD 4072
Country 47316 0
Australia
Phone 47316 0
+61406185750
Fax 47316 0
Email 47316 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
SourceTitleYear of PublicationDOI
EmbaseControlled Trial Examining the Strength-Based Grit Wellbeing and Self-Regulation Program for Young People in Residential Settings for Substance Use.2022https://dx.doi.org/10.3390/ijerph192113835
N.B. These documents automatically identified may not have been verified by the study sponsor.