ANZCTR - Registration

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

Trial registered on ANZCTR

Registration number

ACTRN12618001193268

Ethics application status

Approved

Date submitted

26/06/2018

Date registered

17/07/2018

Date last updated

1/05/2024

Date data sharing statement initially provided

1/05/2024

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]

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

Condition category

Condition code

Mental Health

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 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.

Intervention code [1]

Treatment: Other

Intervention code [2]

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]

The primary outcome is global functioning, which will be assessed using the interviewer-rated Global Assessment of Functioning (GAF) Scale

Timepoint [1]

GAF scores at 6-months as compared to baseline between groups

Secondary outcome [1]

Global functioning scores between groups (RECOVER+TAU vs TAU) using the Global Assessment of Functioning (GAF)

Timepoint [1]