None listed
Conditions
Brief summary
Currently, specialised early interventions are not accessible for a majority of youth with Bipolar Disorder who seek care. We have developed a specialised clinical intervention model (BLEND) integrating evidence-based psychological strategies delivered through digital and face-to-face sessions; psychopharmacological interventions; relapse prevention and online social networking. We will conduct a randomised trial to evaluate the acceptability, safety and feasibility of this intervention, compared with an enhanced model of care currently delivered at the clinic (Enhanced Standard Care or ESC). We will include young people aged between 15 and 25 years, seeking specialised help for the first time for Bipolar Disorder types I or II. After informed consent, we will randomise 20 such young people (2:1) to BLEND or ESC. Interventions will be delivered over 6 months and assessments will be conducted at baseline, 3 and 6 months. This study will help adapt the intervention(s) to improve acceptability, feasibility or safety and enable the next steps in evaluating the efficacy of the BLEND model.
Interventions
During the 6-months of treatment, those young people receiving the BLEND intervention will have visits with a psychiatrist, a clinical psychologist and a care clinician within the BLEND team, with the sessions occurring in-person preferably, but via telehealth if necessary. In addition, young people’s online activities will be tailored by their face to face therapist and moderated by peer workers. Psychopharmacological interventions: The psychiatrist will assess the young people, and provide evidence based pharmacotherapeutic interventions based on a review of guidelines (Chia, 2019), along with updated evidence from the Royal Australian and New Zealand College of Psychiatrists, Clinical Practice Guideline for Mood Disorders (Malhi 2015, 2020). Pharmacotherapeutic interventions (e.g., lurasidone, lithium, or lamotrigine) as well as mental state and recovery, will be reviewed over four planned sessions with the psychiatrist over the intervention period, including liaison with their general practitioner. The sessions will last 30-60minutes and may be spaced 2-12 weeks apart. Psychological interventions: For each young person, a clinical psychologist will provide manualised and formulation driven face-to-face cognitive behavioural therapy based on a locally developed intervention for young people experiencing bipolar disorder (Macneil 2012). The BLEND psychological intervention has particular emphases on psychoeducation for bipolar disorder and social rhythm regulation which are also targeted by online psychological therapy content (embedded within and accessed entirely through the MOST digital platform described below). Participant’s engagement in online therapeutic activities is primarily self-directed, although content can be suggested and tailored for participants by their therapist. Several domains of therapy will be delivered in a blended manner (over the digital platform and in face-to-face sessions) with the clinical psychologist tailoring online and face to face content to suit the individual. Interventions will be delivered via 10-20 (50-60min) face-to-face sessions, over 6 months. Treatment fidelity will be achieved by completion of therapy fidelity checklists and regular clinical supervision. The Moderated Online Social Therapy (MOST): platform is an interactive, purpose built online platform designed to deliver a range of evidence-based and interactive psychosocial interventions. The modules targeting depression, anxiety, social functioning, and vocational functioning are available for all young people irrespective of whether they are in BLEND or Enhanced Standard Care. Those in the BLEND arm will also have access to modules targeting psychoeducation for Bipolar Disorder, and social rhythm therapy. The platform also includes an online social networking environment, which is moderated by peer workers. Participants are able to access psychosocial interventions on MOST 24 hours per day, 7 days per week from any internet-enabled device for the 6 months of the study period. Relapse monitoring intervention: MOST also includes an integrated weekly self-rating tool including a) the Altman Self-Rated Mania Scale and b) self-assessment of need for additional care. For those in the BLEND arm, weekly self-rating supported by SMS prompts or phone calls from their care clinician will be utilised to identify early signs of a relapse. Responses on these questions will lead to a clinical response from the care clinician thereby promoting relapse prevention.
Sponsors
Study design
Eligibility
Inclusion criteria
1. Age 15 to 25 years 2. Diagnosis of BD I or II 3. Ability to provide informed consent and/or have a parent or guardian provide consent on their behalf. 4. Ability and willingness to nominate an emergency contact person, such as a close family member
Exclusion criteria
1. Has previously received 6-months of care through a tertiary mental health service or a multi-disciplinary team for bipolar disorder or psychosis. 2. Currently requiring tertiary mental health intervention or likely to require tertiary intervention in the next 6 months, due to high level of severity, complexity or risk. 3. Experiencing psychosis or manic episode 4. Intellectual disability that interferes with the likelihood of the participant receiving benefit from participation as judged by the treating clinician; 5. Inability to converse in, or read English. English does not have to be the young person’s primary language; Does not have access to the internet and an internet-enabled device; 6. High degree of hostility and impulsivity, as judged by the treating clinician, resulting in the clinician believing that inclusion in the research project may result in harm to the young person or other users (i.e. through interactions in the social network). *Those experiencing a hypomanic episode will be treated, and upon remission, can be admitted to the study.