Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000223932
Ethics application status
Approved
Date submitted
12/02/2020
Date registered
24/02/2020
Date last updated
1/11/2022
Date data sharing statement initially provided
24/02/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Acceptance and Commitment Therapy (ACT) Group Program for Recovery from Psychosis: A Multi-agency Evaluation
Scientific title
A Multi-agency Evaluation of the Routine Practice of an Acceptance and Commitment Therapy Group for Recovery from Psychosis
Secondary ID [1] 300465 0
Nil known
Universal Trial Number (UTN)
U1111-1247-8144
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Psychosis 316133 0
Condition category
Condition code
Mental Health 314424 314424 0 0
Schizophrenia

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
• Brief name: ‘Recovery ACT for Psychosis’ Group Program
• Materials: The ‘Recovery ACT for Psychosis’ Group Program includes seven core group sessions and one booster session. The topics that comprise the seven core group sessions are: introduction to noticing/awareness of present experiences and values; introduction to passengers on the bus metaphor and SMART goals; review of values, noticing and willingness; identification of passengers and different ways of responding to them and development of noticing skills; passengers on the bus and changing relationships with words; review of values and encourage sharing of value-guided actions; review of key group messages.
• Procedures: Psychoeducation, facilitated discussions and reflections, experiential activities (guided informal and formal meditations), reflective activities, planned out-of-session activities, role-play activities. Use of audio-visuals and handout materials to aid learning designed specifically for the intervention (http://actforpsychosis.com/). Reminder calls and/or messages to prompt attendance.
• Who will deliver?: The ‘Recovery ACT for Psychosis’ Group Program is conducted at participating centres either as part of a clinical program of groups routinely offered to consumers, or as periodic opportunities. Group leaders are primarily clinical psychologists employed by the centres as clinical service providers.
• Mode of delivery: Face-to-face in a group setting.
• Frequency of intervention: Eight 90-minute sessions; 7 core group sessions run once per week for 7 weeks, and a booster session about 4 weeks after session 7.
• Location: At community mental health service centres operated by four public health agencies in Melbourne, Australia.
• Personalised?: The intervention will not be personalised, titrated or adapted to groups of individuals in the intervention
• Adherence/fidelity?: Adherence to the intervention will be monitored by the senior investigators. Group clinicians will document whether there were any modifications to the group program. In addition, a semi-structured interview with the group clinicians after each group program will be conducted by senior investigators to gather qualitative data about the group program. The duration of the interview is estimated to be 30 minutes.
Allocation to intervention: The ‘Recovery ACT for Psychosis’ Group Program is an intervention already offered in routine practice in public mental health outpatient centres in Australia. All participants who were referred to (by clinician, treatment team, or self-referred) and decide to attend the ‘Recovery ACT for Psychosis’ Group Program will be invited to participate in the evaluation of the intervention.
Intervention code [1] 316763 0
Treatment: Other
Comparator / control treatment
This study is a single group quasi-experimental trial in that all participants serve as their own control. After consenting to participate in the evaluation and completing an assessment of the primary outcome, there is a minimum 3-4 week wait-list period that all participants undergo prior to the start of the active intervention. On the day of the first group session, all participants complete another assessment of the primary outcome before the session begins. Therefore, there is data for all participants on change in the primary outcome over the baseline period (no active intervention) that will be used to compare to data on change in the primary outcome during the active intervention.
Control group
Active

Outcomes
Primary outcome [1] 322766 0
Changes in the longitudinal trajectory of personal recovery as measured by the 15-item version of the Questionnaire about the Process of Recovery
Timepoint [1] 322766 0
The start of the wait list period (T0), the start of the group (T1 - about 4 weeks after T0), end of the group (T2 - about 10 weeks after T0), the booster session (T3 - about 14 weeks after T0).
The primary timepoint is the start of the group (T1).
Secondary outcome [1] 379658 0
Changes in the longitudinal trajectory of wellbeing as measured by the CORE-10
Timepoint [1] 379658 0
The start of the wait list period (T0), the start of the group (T1 - about 4 weeks after T0), end of the group (T2 - about 10 weeks after T0), the booster session (T3 - about 14 weeks after T0).

Eligibility
Key inclusion criteria
Out-patients aged 18-65; have a primary file diagnosis of either a schizophrenia spectrum or other psychotic disorder, a mood disorder with psychotic features, or a substance-induced psychotic disorder; currently receiving outpatient mental health care at one of the study centres; self-referred or referred by clinical staff to a Recovery ACT group being conducted by a participating centre.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Lack capacity to consent to this evaluation; lack proficiency in speaking and comprehending English; file diagnosis of an intellectual disability (an intellectual development disorder) or borderline personality disorder.

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)
N/A
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
N/A
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The estimated minimum sample size needed in this study to detect an effect is 90. As the statistical analysis plan for the study involves the use of a growth curve structural equation model of the primary outcome (personal recovery), we calculated the minimum sample sized based on the number of observed (5 observed variables from Time 0 to Time 4) and latent variables in the model (2 latent variables for intercept and slope), the anticipated effect size (0.3), and the desired probability (0.05) and statistical power level (80%).

To evaluate the primary outcome, we will use linear mixed-effects modelling to determine whether there is a significant difference in the primary outcome across each time period (T0 to T4).

To quantitatively investigate a model of the trajectory of change in the primary outcome, we will test a univariate latent growth curve model of the primary outcome from T0 (prior to waitlist period) to the start of the group (T1) to the booster session (T4).

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/09/2019
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
160
Accrual to date
51
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 15807 0
St Vincent's Hospital (Melbourne) Ltd - Fitzroy
Recruitment hospital [2] 15808 0
The Alfred - Melbourne
Recruitment hospital [3] 15825 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment hospital [4] 15826 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 29241 0
3065 - Fitzroy
Recruitment postcode(s) [2] 29242 0
3004 - Melbourne
Recruitment postcode(s) [3] 29261 0
3199 - Frankston
Recruitment postcode(s) [4] 29262 0
3082 - Mill Park
Recruitment postcode(s) [5] 29263 0
3072 - Preston
Recruitment postcode(s) [6] 29264 0
3020 - Sunshine
Recruitment postcode(s) [7] 29265 0
3039 - Moonee Ponds
Recruitment postcode(s) [8] 29266 0
3123 - Hawthorn East
Recruitment postcode(s) [9] 29267 0
3002 - East Melbourne
Recruitment postcode(s) [10] 29268 0
3182 - St Kilda
Recruitment postcode(s) [11] 29269 0
3141 - South Yarra
Recruitment postcode(s) [12] 29270 0
3940 - Rosebud West

Funding & Sponsors
Funding source category [1] 304879 0
Hospital
Name [1] 304879 0
Royal Melbourne Hospital
Country [1] 304879 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Department of Psychology & Counselling
La Trobe University
Bundoora VIC 3086
Country
Australia
Secondary sponsor category [1] 305264 0
None
Name [1] 305264 0
N/A
Address [1] 305264 0
N/A
Country [1] 305264 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305292 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 305292 0
Office for Research
The Royal Melbourne Hospital
Level 2 South West
300 Grattan Street
Parkville VIC 3050
Ethics committee country [1] 305292 0
Australia
Date submitted for ethics approval [1] 305292 0
27/02/2019
Approval date [1] 305292 0
30/04/2019
Ethics approval number [1] 305292 0
HREC/51498/MH-2019
Ethics committee name [2] 305349 0
Alfred Health
Ethics committee address [2] 305349 0
Office of Ethics & Research Governance
55 Commercial Road
Melbourne VIC 3004
Ethics committee country [2] 305349 0
Australia
Date submitted for ethics approval [2] 305349 0
07/06/2019
Approval date [2] 305349 0
26/06/2019
Ethics approval number [2] 305349 0
370/19
Ethics committee name [3] 305350 0
St Vincent's Hospital Melbourne
Ethics committee address [3] 305350 0
Research Governance Unit
PO Box 2900
Fitzroy VIC 3065
Ethics committee country [3] 305350 0
Australia
Date submitted for ethics approval [3] 305350 0
16/08/2019
Approval date [3] 305350 0
18/09/2019
Ethics approval number [3] 305350 0
147/19
Ethics committee name [4] 305351 0
La Trobe University
Ethics committee address [4] 305351 0
Research Office
Bundoora VIC 3086
Ethics committee country [4] 305351 0
Australia
Date submitted for ethics approval [4] 305351 0
17/07/2019
Approval date [4] 305351 0
19/07/2019
Ethics approval number [4] 305351 0
HREC/51498/MH-2019
Ethics committee name [5] 308991 0
Peninsula Health Human Research Ethics Committee
Ethics committee address [5] 308991 0
Office for Research
Peninsula Health
PO Box 52
Frankston VIC 3199
Ethics committee country [5] 308991 0
Australia
Date submitted for ethics approval [5] 308991 0
07/05/2020
Approval date [5] 308991 0
23/07/2021
Ethics approval number [5] 308991 0
S.AM/51498/PH-2020-215625(v1)

Summary
Brief summary
The aim of the study is to evaluate whether an internationally recognised group program, Acceptance and Commitment Therapy (ACT) for Recovery from Psychosis, when delivered in routine practice by trained local clinicians, is effective in helping personal recovery for consumers living with psychotic disorders. The group program consists of 7 weekly sessions and one follow-up/booster session, each of 90 minutes duration. Participation in the evaluation is open to consumers who attend a group program as part of their routine clinical care at participating mental health services in Melbourne, Australia. We expect that participants’ personal recovery will stay the same while they wait for the group to start, then their personal recovery will improve from the start to the end of the group and then it will stay about the same after the group ends.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99894 0
Dr Eric Morris
Address 99894 0
Senior Lecturer & Psychology Clinic Director
Department of Psychology & Counselling
La Trobe University
Bundoora VIC 3086
Country 99894 0
Australia
Phone 99894 0
+61 3 9479 2472
Fax 99894 0
Email 99894 0
[email protected]
Contact person for public queries
Name 99895 0
Dr Eric Morris
Address 99895 0
Senior Lecturer & Psychology Clinic Director
Department of Psychology & Counselling
La Trobe University
Bundoora VIC 3086
Country 99895 0
Australia
Phone 99895 0
+61 3 9479 2472
Fax 99895 0
Email 99895 0
[email protected]
Contact person for scientific queries
Name 99896 0
Dr Marilyn Cugnetto
Address 99896 0
Research Assistant
Academic Psychology Unit
NorthWestern Mental Health
Located in Emergency Mental Health area, The Northern Hospital
185 Cooper Street
Epping VIC 3076

Honorary Research Fellow
La Trobe University
School of Psychology and Public Health
Bundoora VIC 3086
Country 99896 0
Australia
Phone 99896 0
+61 3 8405 2618
Fax 99896 0
Email 99896 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
Insufficient resources.


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.