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Trial registered on ANZCTR


Registration number
ACTRN12618001193268
Ethics application status
Approved
Date submitted
26/06/2018
Date registered
17/07/2018
Date last updated
17/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
REsearch into COgnitive and behavioural VERsatility (RECOVER) tailored psychological intervention for early stage bipolar disorder.
Scientific title
A randomised, controlled trial of the RECOVER tailored psychological intervention for improving global functioning in early stage bipolar disorder
Secondary ID [1] 294940 0
Nil known
Universal Trial Number (UTN)
U1111-1216-1265
Trial acronym
RECOVER
Linked study record
N/A

Health condition
Health condition(s) or problem(s) studied:
Bipolar Disorder 307920 0
Condition category
Condition code
Mental Health 306959 306959 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
REsearch into COgnitive and behavioural VERsatility (RECOVER) is an individualised and manualised psychological therapy delivered as adjunctive to treatment as usual (TAU) at specialised early intervention (SEI) services.
RECOVER targets symptoms and psychosocial functioning associated with the early stages of Bipolar Disorder (BD) and was designed to address the challenges and opportunities presented by young people experiencing the early stages of BD.
It comprises eight modules: (i) assessment, engagement and formulation; (ii) psycho-education, insight and adaptation; (iii) medication adherence; (iv) specific CBT interventions for hypomania, mania, and depression; (v) social rhythm regulation; (vi) relationship and family work; (vii) managing alcohol, substance use, and other co-morbidity; and (viii) relapse prevention. The modules are utilised according to clinical need, and are tailored to the young person based on psychological formulation.
Participants in the intervention (RECOVER+TAU) group will receive a minimum of 10 and a maximum of 18 face-to-face, individual sessions of RECOVER over a 6-month period (weekly sessions for the first 10 weeks, fortnightly sessions for the remaining period of time). Treatment sessions are typically of one hour duration. It is expected that participants will miss a session here or there due to fluctuations in illness, time restrictions or other personal circumstances. However, all participants will be offered a maximum of 18 sessions, and a minimum of 10 sessions will be required to perform the proposed statistical analyses.

Participants in the study will also receive TAU at the SEI service they attend. This involves formulation driven case management using an assertive community outreach approach.
RECOVER will be provided to participants by clinical psychologists who have received formal training regarding the delivery of the intervention. Integrity to RECOVER (adherence, competency and separation) will be managed via regular supervision. A treatment fidelity checklist will also be used by clinicians and case-managers to identify components of therapy delivered within each session.
Intervention code [1] 301267 0
Treatment: Other
Intervention code [2] 301268 0
Behaviour
Comparator / control treatment
Treatment As Usual (TAU) group. Participants in this group will receive treatment as usual at specialist early intervention services involving formulation driven case management using an assertive community outreach approach.

Young people with early stage BD are treated with an assertive community outreach approach and formulation driven case management. Case management is provided by mental health nurses, clinical psychologists (including provisional psychologists), occupational therapists or social workers. A young person may be seen for up to 3 years (maximum, depending on age at entry), with a usual length of treatment time of approximately 12 months. Frequency of contact with clinicians takes a phase-specific approach: in the acute phase of illness, young people may be seen once or twice a week, with weekly or fortnightly sessions in the early recovery phase, and tapering down to fortnightly to monthly sessions in the later stage of recovery. Young people with early stage BD are typically seen weekly to fortnightly.
Case management is psychologically informed, with functional recovery for the young person the key objective. Treatment involves monitoring of the young person’s mental state, risk assessments, a focus on medication adherence, physical health and wellbeing, providing family support, psychoeducation, and attending to individual difficulties and comorbid problems. Treatment is provided either one-on-one, with family or in group settings. Psychosocial interventions are also provided to assist the young person to remain involved in work, study and relationships as well as connected to important services such as Legal Aid, Centrelink and housing services.
Control group
Active

Outcomes
Primary outcome [1] 305959 0
The primary outcome is global functioning, which will be assessed using the interviewer-rated Global Assessment of Functioning (GAF) Scale
Timepoint [1] 305959 0
GAF scores at 6-months as compared to baseline between groups
Secondary outcome [1] 347115 0
Global functioning scores between groups (RECOVER+TAU vs TAU) using the Global Assessment of Functioning (GAF)
Timepoint [1] 347115 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [2] 347116 0
Composite global, social and occupational functioning scores between groups (RECOVER+TAU vs TAU) using the Functioning Assessment Short Test (FAST)
Timepoint [2] 347116 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [3] 347119 0
Composite social and occupational functioning scores between groups (RECOVER+TAU vs TAU) using the Social and Occupational Functioning Assessment Scale (SOFAS)
Timepoint [3] 347119 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [4] 348839 0
Composite social and occupational functioning scores between groups (RECOVER+TAU vs TAU) using the Sheehan Disability Scale (SDS)
Timepoint [4] 348839 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [5] 349026 0
Social functioning scores between groups (RECOVER+TAU vs TAU) using the Social Inclusion in Mental Illness – Long Edition (SIMI-LE)
Timepoint [5] 349026 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [6] 349027 0
Social functioning scores between groups (RECOVER+TAU vs TAU) using the Young Schema Questionnaire (YSQ-L3)
Timepoint [6] 349027 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [7] 349028 0
Symptomatology between groups (RECOVER+TAU vs TAU) using the Clinical Global Impression Scale for use in bipolar illness (CGI-BP)
Timepoint [7] 349028 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [8] 349029 0
Symptomatology between groups (RECOVER+TAU vs TAU) using the Young Mania Rating Scale (YMRS)
Timepoint [8] 349029 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [9] 349030 0
Symptomatology between groups (RECOVER+TAU vs TAU) using the Montgomery Åsberg Depression Rating Scale (MADRS)
Timepoint [9] 349030 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [10] 349031 0
Symptomatology between groups (RECOVER+TAU vs TAU) using the General Anxiety Disorder – 7 item (GAD-7)
Timepoint [10] 349031 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [11] 349032 0
Symptomatology between groups (RECOVER+TAU vs TAU) using the Overall Anxiety Severity and Impairment Scale (OASIS)
Timepoint [11] 349032 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [12] 349033 0
Quality of life (QoL) between groups (RECOVER+TAU vs TAU) using the Quality of Life in Bipolar Disorder-Brief (QoL.BD-Brief)
Timepoint [12] 349033 0
At 3, 6, 12 & 18 months after intervention commencement
Secondary outcome [13] 349034 0
Quality of life (QoL) between groups (RECOVER+TAU vs TAU) using the Assessment of Quality of Life (AQoL-8D)
Timepoint [13] 349034 0
At 3, 6, 12 & 18 months after intervention commencement

Eligibility
Key inclusion criteria
- Diagnosis of BD-I: As per Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5; 31);
- Early stage BD: Stage 2 and early illness phases of Stage 3 disorder. At least one manic episode in the previous 2 years, no more than 5 manic or hypomanic episodes over lifetime. This must be the first presentation of help-seeking for mania.
- Length of treatment duration: within the first 6 months of treatment at a SEI service
- Capacity: To consent to the study and comply with study procedures.
Minimum age
15 Years
Maximum age
25 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-Schizophrenia spectrum disorder
-Manic symptoms purely related to periods of peak drug intoxication
-Involvement in another interventional trial, unless discussed and agreed by Investigators, CI and Sponsor to be allowed, on a case-by-case basis
-Presence of developmental disability, and full scale intelligence quotient <70 that would compromise the person’s ability to understand cognitive and behavioural aspects of the intervention
-An inability to speak English without an interpreter

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)
The allocation sequence will be concealed within a web-based Research Project Management System (RPMS) that has been developed at Orygen. Only when an individual’s characteristics are entered by the Trial Coordinator into the web-based system, and eligibility to the trial has been confirmed, will the treatment allocation be made available.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be computer-generated by a statistician independent of the study. It will be based on a permutated block randomisation scheme with stratification for site (OYH sites Parkville and Sunshine, and RAPPS).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
• The primary effectiveness analysis will assess average treatment group differences in change from baseline to 6 months (end of treatment, primary endpoint) for the primary outcome measure (GAF), and will use a restricted maximum likelihood (REML) based mixed-effects model, and a repeated measures approach (MMRM). The MMRM model includes the fixed, categorical effects of treatment, visit, and treatment-by-visit interaction. Planned comparisons will be done within the MMRM to determine between- group differences in change of global functioning from baseline to 6 months (primary effectiveness analysis). Estimated means and standard errors will be presented for each group at each visit.
• Secondary effectiveness analyses will include a more detailed examination of global functioning, including the GAF ratings at 3, 9-, 12-, 15-, and 18-months. Group differences in rates of change from baseline to follow-up visits will be examined using planned comparisons.
• Comparisons between the RECOVER and the RECOVER+TAU groups will be made regarding participant expectations about (i) medications, and (ii) therapy. Site-specific analyses will also be considered.
• A range of models of mediation and moderation will be used to analyse the relationship between treatment, medication adherence, maladaptive schemas, regularity in daily routines and global functioning. This may include single level or multilevel mediation models.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 10954 0
Orygen Youth Health - Parkville - Parkville
Recruitment hospital [2] 10955 0
Orygen Youth Health - Sunshine - Sunshine
Recruitment hospital [3] 11195 0
Dandenong Hospital - Dandenong
Recruitment postcode(s) [1] 22740 0
3052 - Parkville
Recruitment postcode(s) [2] 22741 0
3020 - Sunshine
Recruitment postcode(s) [3] 23056 0
3175 - Dandenong

Funding & Sponsors
Funding source category [1] 299525 0
Government body
Name [1] 299525 0
National Health and Medical Research Council
Address [1] 299525 0
414 La Trobe St
Melbourne VIC 3000
Country [1] 299525 0
Australia
Primary sponsor type
Other
Name
Orygen, The National Centre of Excellence in Youth Mental Health
Address
35 Poplar Rd, Parkville VIC 3052
Country
Australia
Secondary sponsor category [1] 298850 0
None
Name [1] 298850 0
Address [1] 298850 0
Country [1] 298850 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300422 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 300422 0
Office for Research
Level 2
South West
300 Grattan Street
Parkville Victoria 3050
Ethics committee country [1] 300422 0
Australia
Date submitted for ethics approval [1] 300422 0
28/11/2017
Approval date [1] 300422 0
15/01/2018
Ethics approval number [1] 300422 0
HREC/17/MH/204

Summary
Brief summary
Bipolar Disorder (BD) is an affective psychotic disorder characterised by extreme changes in mood, thoughts and behaviour. BDI disorder epitomises the classic manic depressive description of BD with characteristic periods of mania and depression. The severity of symptoms impacts on social and occupational functioning.

In the early stages of illness, despite potential symptomatic recovery, functional recovery is less common. Social and occupational functioning are surprisingly poor, despite evidence that this group displays exemplary functional performance prior to illness onset. Furthermore, if functional recovery is not achieved early, positive outcomes are rarely attained later.

Psychological interventions appear more effective in early stages of BD than later illness stages. Our group developed a novel psychological intervention for young people with early stage BD, in collaboration with end users, and tailored to the specific needs of the intended population. The intervention (known as RECOVER), specifically targets symptoms and psychological functioning, with pilot data indicating it as being effective in reducing depressive symptoms (the major burden of BD) and resulting in better functional outcomes than treatment as usual (TAU) at an early psychosis service.

This study will provide definitive support for the utility of RECOVER. The aims of the project are to:
(i) Refine RECOVER for translation beyond the specialist service in which it was developed;
(ii) Evaluate the effectiveness of RECOVER for improving symptom, global functioning and quality of life outcomes, in early-stage BD; and
(iii) Investigate mechanisms that may underpin changes in functioning

Participants will include 122 young people aged between 15-25 years, admitted to Orygen Youth Health (OYH, Melbourne Health) or the Recovery and Prevention of Psychosis Service (RAPPS, Monash Health) for treatment of early stage bipolar disorder.
The participants will be randomised into one of two groups: RECOVER+TAU, or TAU. Participants in the RECOVER+TAU group will receive weekly to fortnightly sessions of RECOVER for up to 6months, with the primary endpoint at this time. All participants will complete follow-up assessments for 18months.

The primary outcome is global functioning, with greater results expected in the RECOVER group. A range of symptomatic, quality of life, and functioning measures will be included as secondary outcomes. Treatment related variables will be explored, with measures of medication adherence, maladaptive schemas, comorbidity, premorbid functioning, participant expectations and therapeutic alliances included.
Trial website
Nil
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83614 0
Prof Sue Cotton
Address 83614 0
Orygen, The National Centre of Excellence in Youth Mental Health & Orygen Youth Health, 35 Poplar Rd, (Locked Bag 10), Parkville Victoria 3052
Country 83614 0
Australia
Phone 83614 0
+61 407 340 115
Fax 83614 0
Email 83614 0
sue.cotton@orygen.org.au
Contact person for public queries
Name 83615 0
Prof Sue Cotton
Address 83615 0
Orygen, The National Centre of Excellence in Youth Mental Health & Orygen Youth Health, 35 Poplar Rd, (Locked Bag 10), Parkville Victoria 3052
Country 83615 0
Australia
Phone 83615 0
+61 407 340 115
Fax 83615 0
Email 83615 0
sue.cotton@orygen.org.au
Contact person for scientific queries
Name 83616 0
Prof Sue Cotton
Address 83616 0
Orygen, The National Centre of Excellence in Youth Mental Health & Orygen Youth Health, 35 Poplar Rd, (Locked Bag 10), Parkville Victoria 3052
Country 83616 0
Australia
Phone 83616 0
+61 407 340 115
Fax 83616 0
Email 83616 0
sue.cotton@orygen.org.au

No information has been provided regarding IPD availability
Summary results
No Results