Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001746224
Ethics application status
Approved
Date submitted
20/04/2018
Date registered
24/10/2018
Date last updated
17/09/2020
Date data sharing statement initially provided
2/10/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Indigenous Model of Mental Health Care
Scientific title
Indigenous Model of Mental Health Care: A randomised controlled trial based on a trans-diagnostic Cognitive Behavior Therapy program co-designed with Community, targeting participants with depression
Secondary ID [1] 294617 0
IMMHC Study
Universal Trial Number (UTN)
U1111-1222-5849
Trial acronym
IMMHC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depression 307450 0
Condition category
Condition code
Mental Health 306537 306537 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This will be delivered by qualified psychologists, who will be trained in the treatment package. The psychologists will receive weekly supervision and fidelity will be assessed by video-taping a random selection (n=20) of sessions. Treatment will consist of both individual and group psychotherapy, as described below. Individual sessions will comprise of tailored, trans-diagnostic CBT; group sessions (co-facilitated with an Indigenous Health Worker; IHW) will involve a focus on skills practice, including yarning about successes and difficulties in application, and obtaining peer support and reinforcement in this area.

Individual Treatment: The first one or two sessions will involve the assessment of cognitive and behavioural factors maintaining the disorder. As the SCID-I study has demonstrated that these assessments are typically lengthy, these treatment sessions will be up to 90-minutes. The treating psychologist will then develop a tailored treatment plan, in consultation with a senior clinical psychologist and the participant. Changes in symptomatology may warrant adjustments or changes to the treatment plan. Up to 12 sessions of individual treatments will be provided by qualified psychologists using a combination of face-to-face delivery for primary treatment and telephone delivery to facilitate skills practice.

Group Treatment: The efficacy of CBT relies on the use of ‘homework’ or skills practice to maintain treatment effects. We believe that skills practice will be difficult for many Indigenous participants so we will use group sessions for practice (in addition to telephone contacts as above). As such, a ‘Yarning Skills Group’ is planned as an adjunct to individual sessions. The purpose of this group is to build on skills learnt in individual sessions, allow peer support in a positive supportive environment, and focus on personal and group strengths.
Group treatment aims to be therapeutic, strengths-based, and culturally friendly by: using both a psychologist, spiritual healers and Indigenous Health Workers as group facilitators; exploring successes in applying skills and learnings obtained from individual sessions; and allowing peers to support each other through learning new behaviours. Consistent with another evidence-based therapy that has adapted CBT for complex presentations using both individual and group CBT, a different psychologist will be used for individual and group sessions. Participants will be offered up to 3 group sessions:, after week 5, after week 8, and after week 10/12 of the intervention. Groups of 10-12 participants will be offered combined treatment in group settings.

The study will now also facilitate the conduct of a remote telehealth model of participant recruitment, screening and participation utilising available video-consultation technology. Participants with access to video-consultation resources in their homes will be able to participate at home; those without such resources will have the option to utilise a telehealth service setup in a private room located at the participating Aboriginal Medical Services.

Intervention Schedule:

Week 1: Overall assessment this includes clinical history and history enough information for a clinical formulation
Week 2: Feedback to the client, Psychoeducation about CBT. Commencement of Behavioural Activation and/or Relaxation Strategies. These are incorporated into in-between session practice.
Week 3-5: Review of Practice and techniques, commencement of identifying links between thoughts, beliefs, emotions and behaviours.
Week 5-8: Challenging thoughts, beliefs and behaviours (‘traps’) that are unhelpful and impact on negative emotions that are linked to depression and anxiety. During this process the client will become increasingly skilled at in identifying these traps and modifying these him or herself. Behavioural activation and relaxation is continues both in session and in between sessions.
Week 9-10/12: Consolation of cognitive and behavioural techniques, Relapse management planning.
Intervention code [1] 300922 0
Treatment: Other
Comparator / control treatment
Treatment as usual - Participants who are randomised into the TAU group will receive the standard treatment offered to clients with a diagnosed mental illness. This may include: referral to the medical service or independent psychologist; a Mental Health Care plan; and/or medication.
Control group
Active

Outcomes
Primary outcome [1] 305543 0
The difference between changes in the control and intervention groups on depression scores as measured by BDI-II from baseline to 6 months.
Timepoint [1] 305543 0
6 months post baseline
Secondary outcome [1] 345689 0
The difference of change in scores as measured by BDI-II from baseline to 12 months, between the TAU and IMMHC group.
Timepoint [1] 345689 0
12 months post baseline
Secondary outcome [2] 345690 0
Comparison of changes in Quality of Life (QoL) measured using AQoL-8D
Timepoint [2] 345690 0
Changes in QoL between baseline and 6 months; other changes between baseline and 12 months
Secondary outcome [3] 345691 0
Anxiety: Changes in Beck Anxiety Index (BAI)
Timepoint [3] 345691 0
Baseline to 6 months and baseline to 12 months
Secondary outcome [4] 345692 0
Changes in the presence of major depression, anxiety or substance use disorder(s), as established by a SCID-5-CV interview. This is a composite secondary outcome.
Timepoint [4] 345692 0
Baseline to 12 months
Secondary outcome [5] 345693 0
Changes in number of mental health diagnoses as determined by the patients medical records.. This is a composite secondary outcome.
Timepoint [5] 345693 0
Diagnostic status of initial mental health conditions will be evaluated using SCID-5-CV at 6 months and 12 months
Secondary outcome [6] 345694 0
Thematic analysis to explore reasons why participants may or may not engage with the study or choose to drop out. Data for thematic analysis will be collected by audio recorded group sessions / focus groups.
Timepoint [6] 345694 0
Baseline to 12 months
Secondary outcome [7] 353176 0
Changes in patterns of psychotrophic medication use as determined by the patients medical records.
Timepoint [7] 353176 0
Baseline to 12 months

Eligibility
Key inclusion criteria
Key inclusion criteria: • Age 18 years or older
• Aboriginal and/or Torres Strait Islander identification
• Current (30-day) diagnosis of depression (any subtype), with or without other mood, anxiety or substance use disorder(s), diagnosed on SCID-5-CV interview.
• Written, verbal or electronic informed consent needs to be provided
• Sufficient English language proficiency to provide informed consent and complete study questionnaires
• For those who opt a telehealth model of participation, sufficient access to technology that will facilitate telehealth video-consultations will be a requirement
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Cognitive impairment as assessed by the shortened version of the Kimberley Indigenous Cognitive Assessment (KICA Screen) score <21/25) Subjects with KICA <21 will be referred for medical assessment.
• Assessed after SCID-5-CV interview as high-risk of suicide
• Organic brain disorder
• Recent (< 6 weeks) changes in psychiatric medication
• Any mental or physical condition requiring hospital admission during the study period
• Diagnosis of Bipolar disorder or psychotic disorder
• In the opinion of a psychiatrist/clinical psychologist, other mental disorder (e.g. severe personality disorder) likely to interfere with participant’s ability to complete the study
• Any medical condition likely to prevent participation in the study for 12 months.

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)
Concealment will be achieved using opaque envelopes. Those who prepare the randomisation list or the concealed envelopes will not be involved in recruitment or data collection.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants will be randomly allocated to the intervention group or the control (treatment as usual) group (1:1 ratio) in block sizes of 2, 4, 6, 8 and 10. Block sizes will be allocated unequally using Pascal’s triangle in the ratio 1:4:6:4:1. This will reduce any predictability of the randomisation codes or the blocks.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Quantitative analysis
Intention to treat principles will be used for all analyses. Differences in mean change in BDI-II scores from baseline to 6 months between the two groups will be analysed using repeated measures ANOVA, with treatment as the between-subjects factor, and time as within-subjects factor, and an interaction term (time and treatment group). Additional analyses will use mixed models taking into account baseline covariates including Quality of Life. We will also calculate the differences between the groups using hierarchical mixed models for continuous variables (BDI-II and BAI scores measured at three time points – baseline, 6 months and 12 months) containing random intercept and random slope as well as fixed effects for treatment. We will also evaluate changes in diagnostic status using logistic and/or Poisson regression models.

Qualitative analysis
Thematic analysis will be undertaken to identify recurring themes in the interview transcripts, transcribed from the focus groups, yarning sessions, and patient interviews.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
28/01/2019
Actual
21/03/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
110
Accrual to date
13
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 299234 0
Government body
Name [1] 299234 0
National Health and Medical Research Council
Country [1] 299234 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia QLD 4072 Australia
Country
Australia
Secondary sponsor category [1] 298508 0
None
Name [1] 298508 0
Address [1] 298508 0
Country [1] 298508 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300156 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 300156 0
Ethics committee country [1] 300156 0
Australia
Date submitted for ethics approval [1] 300156 0
22/11/2017
Approval date [1] 300156 0
06/03/2018
Ethics approval number [1] 300156 0
2017001872

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

Contacts
Principal investigator
Name 82726 0
Dr Maree Toombs
Address 82726 0
Rural Clinical School Research Centre
Locked Bag 9009
Toowoomba DC
Qld 4350
Country 82726 0
Australia
Phone 82726 0
+61746339703
Fax 82726 0
Email 82726 0
[email protected]
Contact person for public queries
Name 82727 0
Maree Toombs
Address 82727 0
Rural Clinical School Research Centre
Locked Bag 9009
Toowoomba DC
Qld 4350
Country 82727 0
Australia
Phone 82727 0
+61746339703
Fax 82727 0
Email 82727 0
[email protected]
Contact person for scientific queries
Name 82728 0
Maree Toombs
Address 82728 0
Rural Clinical School Research Centre
Locked Bag 9009
Toowoomba DC
Qld 4350
Country 82728 0
Australia
Phone 82728 0
+61746339703
Fax 82728 0
Email 82728 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data is confidential and will require ethical and local governance approval before being available for sharing.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
5079Ethical approval  [email protected] On request via email.



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAustralian Indigenous model of mental healthcare based on transdiagnostic cognitive-behavioural therapy co-designed with the Indigenous community: Protocol for a randomised controlled trial.2020https://dx.doi.org/10.1192/bjo.2020.16
N.B. These documents automatically identified may not have been verified by the study sponsor.