Data

MOMENTUM: Enhancing Social Functioning in Young People at Ultra High Risk (UHR) for Psychosis: RCT of a Novel Strengths-based Online Social Therapy

orygen

Dataset description

The dataset contains a wide range of variables collected from a randomized controlled trial (RCT) evaluating the effectiveness of Momentum, a moderated online social networking system, in enhancing social functioning among young individuals at Ultra High Risk (UHR) for psychosis. Key variables include participant demographics, frequency and duration of Momentum platform usage, interactions within the social network, and engagement with therapeutic content. Social functioning is assessed via the Global Functioning Social Scale at baseline, and at 4, 8, and 12 months post-randomization. Secondary outcome measures captured in the dataset include assessments of psychosis onset (using CAARMS), role functioning, depression, anxiety, stress, loneliness, vocational status, and quality of life. Additionally, the dataset includes daily ecological momentary assessments (EMA) tracking real-time experiences of social interactions and well-being, passive sensing data from smartphone sensors (for those who opt-in), and therapeutic alliance measures for participants in the intervention group. Adverse events and serious adverse events are also recorded throughout the study duration.
Click to explore relationships graph

Subjects

FOR: Mental Health |

Source Study

Purpose

Treatment

Phase

Not Applicable

Funding

Government body,National Health and Medical Research Council

Scientific enquiries

Mrs Daniela Cagliarini

Brief Summary

The study aims to evaluate, via a randomised controlled trial (RCT), the effectiveness of Momentum, a moderated online social networking system in improving social functioning in young people (aged 14-27) at Ultra High Risk (UHR) for psychosis. Momentum includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topics relevant for UHR young people. Momentum also includes a social network where participants can communicate via posts and comment ....
Read more

Key Inclusion Criteria

1. Age 14 to 27 years inclusive; 2. Ability to read and converse in English; 3. Ability to provide informed consent; 4. Ability and willingness to nominate an emergency contact person, such as a close family member; 5. Meeting criteria for one or more UHR for psychosis groups (Vulnerability group, Attenuated Psychotic Symptoms group or Brief Limited Intermittent Psychotic Symptoms (BLIPS) group).

Key Exclusion Criteria

1. Past history of a psychotic episode of one week or longer; 2. Acute risk of self-harm requiring urgent intervention (i.e., suicidal ideation with a current plan and intent to enact this plan); 3. Inability to converse in, or read English; 4. Attenuated psychotic symptoms only present during acute intoxication. 5. Organic brain disease known to cause psychotic symptoms, e.g. temporal lobe epilepsy. 6. Any metabolic, endocrine or other physical illness, e.g. thyroid disease, with known neuropsy ....
Read more

Can healthy volunteers participate?

No

 

Population

Sample Size    220

Min. age    14 Years

Max. age    27 Years

Sex    Both males and females

Condition category    Ultra-high risk for psychosis

Condition code    Mental Health

Intervention

Intervention code Behaviour , Treatment: Other

Participants will receive their usual treatment and have access a moderated online social networking system, called Momentum. Momentum is an online intervention specifically designed to enhance social functioning in young people at ultra-high risk for psychosis (UHR). The Momentum system is based on the Moderated Online Social Therapy (MOST) platform developed by eOrygen. Momentum includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topi ....
Read more

Comparison

Control group Active

Participants in the control group will receive treatment as usual. Treatment as usual (TAU) consists of a range of treatment options delivered by treating teams at the Personal Assessment and Crisis Evaluation Clinic (at Orygen Youth Health) or headspace prior to discharge or, after discharge, generic medical or mental health services typically available to young people in the absence of enrolement in the study. These can include follow-up by a general practitioner, private psychiatrist, primary ....
Read more

Outcomes

Outcome: Social functioning - This will be measured by the Global Functioning Social Scale, a valid and reliable instrument designed to measure social functioning in Ultra High Risk (UHR) young people (Cornblatt et al., 2007)
Timepoint: Social functioning will be assessed at baseline and 4, 8, and 12 (primary timepoint) months post randomisation.

Data Dictionary: Not Available

Will individual participant data (IPD) for this trial be available?

yes

What data in particular will be shared?

All of the individual trial-related participant data collected during the trial, after de-identification.

When will data be available?

Immediately following publication 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 sharing policy

Available for what types of analyses?

Any approved protocol, IPD meta-analysis or systematic review. Assessed on a case-by-case basis.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au