None listed
Conditions
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.
Interventions
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
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) assessment and engagement; (ii) cognitive behavioural formulation; (iii) making sense of what happened (psycho-education, insight and adaptation); (iv) social rhythm regulation; (v) specific CBT interventions (for hypomania, mania, and depression) and schema work; (vi) wellness planning. There are four optional modules: (vii) relationship and family work; (viii) managing alcohol, substance use, and other co-morbidity; (ix) medication adherence, and (x) functional recovery. 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.
Sponsors
Orygen
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
15 Years to 25 Years
Healthy volunteers
No
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.
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
Outcome results
None listed