REsearch into COgnitive and behavioural VERsatility (RECOVER) tailored psychological intervention for early stage bipolar disorder.
OrygenDataset description
The RECOVER Trial dataset is derived from a randomized controlled study evaluating the efficacy of the RECOVER psychological intervention for young individuals (aged 15-25 years) with early-stage bipolar disorder (BD). The study aims to refine and assess the effectiveness of RECOVER, a novel psychological intervention developed in collaboration with end users, to improve symptom management, global functioning, and quality of life outcomes. The trial involves 122 participants admitted to Orygen Youth Health (OYH, Melbourne Health) or the Recovery and Prevention of Psychosis Service (RAPPS, Monash Health). Participants are randomly assigned to either the RECOVER+TAU (Treatment As Usual) group or the TAU-only group. Those in the RECOVER+TAU group receive weekly to fortnightly sessions of the RECOVER intervention for up to six months, with follow-up assessments conducted over an 18-month period.Subjects
FOR: Mental Health |Identifiers
Source Study
Trial name (public)
REsearch into COgnitive and behavioural VERsatility (RECOVER) tailored psychological intervention for early stage bipolar disorder.Trial acronym
RECOVER
Trial ID
ACTRN12618001193268
Purpose
Treatment
Phase
Not Applicable
Funding
Government body,National Health and Medical Research Council
Scientific enquiries
Prof Sue Cotton
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 evide .... Read more
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. - 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.
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
Can healthy volunteers participate?
No
Population
Sample Size 67
Min. age 15 Years
Max. age 25 Years
Sex Both males and females
Condition category Bipolar Disorder
Condition code Mental Health
Intervention
Intervention code Behaviour , Treatment: Other
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 six core modules: (i) assessm .... Read more
Comparison
Control group Active
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 s .... Read more
Outcomes
Outcome: The primary outcome is global functioning, which will be assessed using the interviewer-rated Global Assessment of Functioning (GAF) ScaleTimepoint: GAF scores at 6-months as compared to baseline between groups
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
All of the individual participant data collected during the trial, after de-identification.
When will data be available?
Data will be available after the main results have been published for an indefinite time.
Available to whom?
Data will potentially be available to researchers from not-for profit organisations, commercial organisations or other based in any location. All data requests will be considered by the data custodian and the primary sponsor on a case-by-case basis. Requests must include a methodologically sound proposal. Specific conditions of use may apply and will be specified in a data sharing agreement (or similar) that the requester must agree to before access is granted. For further information, see Orygen data management policy.
Available for what types of analyses?
To any type of analyses. Assessed on a case-by-case basis.