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The PHAstER Trial: Physical Health Assistance in Early Recovery of Psychosis

The dataset captures a range of variables from a randomized controlled trial (RCT) evaluating the impact of a physical health nurse on improving the physical health of young people experiencing a first episode of psychosis. Key variables include participant demographics, metabolic health indicators (e.g., body weight, BMI, waist circumference, blood pressure, fasting glucose, cholesterol), and measures of physical activity tracked via actigraphs and the Simple Physical Activity Questionnaire (SIMPAQ). The dataset also includes secondary outcomes such as symptom severity (assessed via BPRS and SANS), psychological functioning (SOFAS), sexual health, substance use (ASSIST), and sleep quality (PSQI, ISI, MEQ). Additionally, satisfaction with services is recorded through the Youth (Mental Health) Service Satisfaction Scale (YSSS). Measurements were taken at multiple timepoints: baseline, 4 weeks, 8 weeks, 12 weeks, and 26 weeks post-intervention.

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

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.

MYSS-HYPE: A pilot study of contingency management for smoking cessation in young people with Borderline Personality Disorder features

The dataset consists of multiple key variables related to an open-label pilot study examining Contingency Management (CM) for smoking cessation in individuals with Borderline Personality Disorder (BPD) features. The variables include participant demographics (e.g., age, gender), session attendance records across eight weekly interventions, and results from carbon monoxide breath tests that measure smoking abstinence. Additionally, it captures financial reward amounts, detailing weekly cash incentives linked to abstinence verification, and adherence tracking to the CM protocol. The dataset also includes variables related to concurrent Treatment As Usual (TAU), documenting psychosocial care, psychiatric treatments, referrals to Quitline, and any pharmacotherapy prescribed during the intervention. Follow-up data at 8 weeks and 16 weeks, such as smoking status and adherence, are also present. No control group data is included, as this was an uncontrolled pilot study.

Imagery Rescripting of Mental Images of Suicide, A Feasibility Study

The dataset evaluates the feasibility, acceptability, and safety of using Imagery Rescripting (IR) as a therapeutic intervention for young people experiencing mood disorders and suicidal ideation. Primary outcomes focus on intervention acceptability, participant recruitment and retention, and safety, with IR sessions aiming to reduce risk-increasing mental images of suicide over 2-4 weekly therapy sessions. Secondary outcomes assess changes in suicidal ideation (C-SSRS), depressive symptoms (QIDS), anxiety (OASIS), and mania (ASRM), collected at each session and a final follow-up. Additional variables capture clinician adherence to protocol, session attendance, and support provided via supervision. This dataset supports analysis of IR’s potential as a targeted intervention to alter distressing mental imagery associated with suicidal thoughts in at-risk youth.

CanARY Study : The effect of Cannabidiol on positive psychotic symptoms in At Risk for psychosis Youth

This dataset captures data from a randomized controlled trial evaluating the feasibility of cannabidiol (CBD) as a treatment for young people aged 12-25 at Ultra-High Risk (UHR) of psychosis. It includes information on participants’ adherence to the intervention, which involved daily doses of 600mg or 1000mg of CBD or a placebo over 12 weeks. The dataset records clinical assessments, adverse events, medication adherence, and biomarker data (e.g., blood, urine, hair samples) collected at multiple time points, including baseline, weeks 4, 8, 12, and follow-up visits up to 104 weeks. The dataset from the CanARY Study includes key variables assessing the impact of cannabidiol (CBD) on positive psychotic symptoms in youth at Ultra-High Risk (UHR) of psychosis. Primary outcomes measure the severity of psychotic symptoms using the Comprehensive Assessment of At-Risk Mental States (CAARMS), tracked at multiple points from baseline through week 104. Secondary outcomes cover a range of psychological and health metrics, including depression (MADRS), anxiety (HAM-A, OASIS), sleep quality (PROMIS-SD), and general psychopathology (BPRS, NSI-PR). Functioning is measured with the Social and Occupational Functioning Assessment Scale (SOFAS), and quality of life is assessed with AQoL-8D, providing a comprehensive view of participants’ well-being. Data on adherence to the CBD regimen, adverse events (CTCAE), and cost-effectiveness (RUQ) are also included, with biomarker data from blood, urine, and hair samples to objectively monitor intervention effects.

INTEGRATE: An integrated treatment to decrease psychological distress and substance use in young people seeking help for emerging mental illness.

This dataset includes information from a randomized controlled trial evaluating the efficacy of the INTEGRATE intervention, a manualized psychological treatment aimed at reducing mental health difficulties and substance use in young people aged 12-25. The dataset captures details on treatment session attendance, content covered, session length, and treatment fidelity for participants receiving up to 10 sessions of INTEGRATE therapy over 16 weeks. It also includes data on the control group, who received treatment as usual (TAU), with psychological interventions recorded by clinicians. The primary outcomes measured are changes in alcohol and drug use between the INTEGRATE and TAU groups.

A Randomised Controlled Trial of the Efficacy of the Men in Mind Training on Mental Health Practitioners’ Clinical Competencies for Working with Male Clients

The dataset from the “Men in Mind” trial includes variables evaluating the efficacy of an online training program aimed at enhancing mental health practitioners’ clinical competencies in engaging male clients in therapy. Core variables focus on pre- and post-training scores on the Engaging Men in Therapy Scale (EMITS) to assess clinicians’ engagement skills, along with the Counsellor Self-Efficacy Scale (COSE) and Development of Psychotherapists Common Core Questionnaire (DPCCQ) for evaluating self-efficacy and clinical skills. Additional variables capture participant engagement with training modules, adherence levels, and outcomes across different timepoints, including immediate post-intervention and follow-up assessments at 6 and 12 weeks. Data also include comparisons between intervention and waitlist control groups to measure primary and secondary outcomes, providing insight into the retention of learning and skill application. This dataset facilitates analysis of the impact of gender-focused training on clinician competencies, with randomized assignment ensuring robust comparison of outcomes across groups.

Personality disorder in young people: Evaluation of Screening measures And the safety and acceptability of relational Peer Work (EScAPe)

This dataset captures information from a pilot clinical trial involving young people aged 12-25 years with personality disorder who received up to 10 sessions of relational peer work over 13 weeks. The dataset includes details on treatment attendance, the content of peer work sessions, participant demographics, and outcomes related to psychosocial functioning, distress, self-care, help-seeking behaviours, personality pathology, depressive symptoms, anxiety, and substance use. Additionally, it records fidelity measures, including the use of standardized training resources and supervision for peer workers. The dataset does not include a control group.

REDUCE: Does Antipsychotic Dose Reduction Lead to Better Functional Recovery in First Episode Psychosis: A Randomised Controlled Trial

This dataset pertains to a randomized controlled trial investigating whether reduced antipsychotic dosage combined with Evidence-Based Intensive Recovery Treatment (EBIRT) leads to improved functioning in young people recovering from first episode psychosis (FEP). The trial includes two groups: one receiving a dose reduction strategy (DRS+) combined with EBIRT, and the other receiving antipsychotic maintenance treatment (AMTx+) along with EBIRT. Additionally, 40 healthy controls will be assessed for comparison across multiple time points. The study aims to assess clinical, cognitive, and physical health outcomes over a 15-18 month treatment period with follow-up at 24 months.

The efficacy and mechanisms of action of N-acetylcysteine as an adjunct treatment for first episode psychosis (ENACT)

Dataset derived from a 52-week randomized, double-blind, placebo-controlled trial investigating the efficacy of N-acetyl cysteine (NAC) as an adjunctive treatment for young individuals experiencing first episode psychosis (FEP). The study aims to determine if NAC, administered at 2000 mg daily in addition to treatment as usual (TAU), can reduce symptom severity and prevent the progression of early psychosis into a chronic disorder. The trial involves 162 participants aged 15-25 years, recruited from the Early Psychosis Prevention and Intervention Centre, who are randomized to receive either NAC or placebo for 26 weeks, followed by a 26-week non-treatment follow-up period.

The Candesartan Adjunctive Bipolar Depression Trial – CADET: A double-blind, randomised, placebo-controlled trial to evaluate the effect of Candesartan on mood in patients with bipolar depression

The CADET-BD trial dataset is derived from a multi-site, double-blind, randomized, placebo-controlled 16-week study designed to evaluate the efficacy of candesartan 16 mg/day as an adjunctive treatment for bipolar depression. This study addresses the significant unmet need for effective depression treatments in bipolar disorder, as current therapies are more effective for managing mania than depression. Candesartan, an AT1R antagonist, is hypothesized to target key biological factors implicated in the pathophysiology of bipolar disorder, such as stress reactivity, the HPA axis, oxidative and inflammatory stress, and neurogenesis. The study aims to recruit 240 participants aged 18 years and above with moderate to severe bipolar depressive disorder. Participants will be randomly assigned to either the active treatment group (candesartan) or the placebo group, in addition to their usual treatment regimen. The primary outcome measure is the change in depressive symptoms, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), with secondary outcomes including additional mental and physical health indicators.

The Candesartan Adjunctive Major Depression Trial – CADET: A double- blind, randomised, placebocontrolled trial

The CADET-UD trial dataset is derived from a multi-site, double-blind, randomized, placebo-controlled 16-week study examining the efficacy of candesartan 16 mg/day as an adjunctive treatment for major depressive disorder (MDD). The trial aims to recruit 240 participants aged 18 years and above with moderate to severe MDD. Candesartan, an AT1R agonist, is hypothesized to target key biological factors involved in the pathophysiology of major depressive disorder, including stress reactivity, the HPA axis, oxidative and inflammatory stress, and neurogenesis. The study employs permutated block randomization to allocate participants to either the active treatment or placebo group in a 1:1 ratio, ensuring blinding across participants, administrators, outcome assessors, and data analysts. The primary outcome measure is the change in depressive symptoms, assessed using the Montgomery-Åsberg Depression Rating Scale (MADRS), with secondary outcomes including additional mental and physical health indicators.

The CALM Trial: Curbing Anxiety and Depression using Lifestyle Medicine

The CALM Trial dataset stems from a single-site, two-arm, individually randomized group treatment, non-inferiority trial aimed at evaluating the effectiveness and cost-effectiveness of an integrated lifestyle program (CALM) versus psychotherapy in reducing symptoms of depression in individuals experiencing COVID-19 related mental health issues. The trial focuses on both mental and physical health outcomes, leveraging telehealth delivery for both interventions over an 8-week period. The dataset involves 184 participants aged 18 years and above, who are experiencing elevated distress, anxiety, and/or depression (Distress Questionnaire-5, DQ5 score >8). Participants are randomly assigned to either the CALM program, which integrates diet and physical activity components, or a psychotherapy program. The primary aim is to determine non-inferiority in depression symptom reduction, with secondary aims including the assessment of other mental and physical health outcomes such as cardiovascular biomarkers.

Staged treatment in Early Psychosis (STEP): A sequential multistage randomised clinical trial of interventions for Ultra High Risk of psychosis patients

Dataset originates from a Sequential Multiple Assignment Randomised Trial (SMART) designed to evaluate the efficacy of various interventions for young people at ultra high risk (UHR) of psychosis. The study was conducted across five Melbourne clinics, recruiting 340 participants who met the study criteria. The interventions assessed include Support and Problem Solving, Cognitive Behaviour Case Management, and antidepressant medication. The primary aim is to develop individualized treatment strategies that can effectively reduce the risk of progression to psychosis and improve functional outcomes. The randomisation process was protected to ensure treatment allocation remained concealed until participants progressed to Steps 2 and 3. The randomisation schedule was generated by an independent statistician using computer-generated random numbers. Blinding was implemented to mask participants, clinicians, outcome assessors, and data analysts from treatment allocation to maintain the integrity of the trial.

Kindred: A pilot study of moderated online social therapy for carers of youth with borderline personality disorder

Dataset encapsulates comprehensive usage and interaction data from the Kindred MOST program, a web-based intervention designed to support carers of young people with borderline personality disorder (BPD). Kindred integrates three main components: (1) online psychoeducation and interactive therapy structured into 9 thematic pathways and 45 steps, focusing on various aspects like understanding BPD, self-care, and enhancing communication skills; (2) a moderated social networking platform termed “cafe,” where users can engage with peers and experts; and (3) peer moderation to facilitate user interactions and provide support. Each user’s interaction with these components—ranging from educational engagement to social networking activities—is meticulously tracked and structured in this dataset.

MOBY: A randomised controlled trial of three forms of psychosocial early intervention for borderline personality disorder in youth.

Dataset from a randomized controlled trial aimed at evaluating the effectiveness of early intervention methods for young individuals (aged 15-25) diagnosed with Borderline Personality Disorder (BPD) who are seeking treatment for the first time. The study compares three distinct interventions: two specialized forms of the “Helping Young People Early” (HYPE) intervention—one with and one without 16 sessions of individual Cognitive Analytic Therapy (CAT)—and a control group receiving general youth mental health care of equivalent duration. The primary outcomes assessed are improvements in interpersonal problems and social adjustment at 12 and 18 months post-enrolment. The dataset is designed to identify which intervention most effectively aids in the early stages of BPD management, with the hypothesis that HYPE combined with CAT will yield superior outcomes.

VERBATIM: A randomised controlled trial of aripiprazole for the treatment of auditory verbal hallucinations in borderline personality disorder

This dataset originates from a 12-week, single-centre, randomized controlled trial (RCT) that examines the efficacy of aripiprazole versus placebo in treating auditory verbal hallucinations (AVHs) in 15-25 year-olds diagnosed with Borderline Personality Disorder (BPD). The study addresses a critical gap in clinical practice by testing conventional pharmacotherapy used for AVHs in schizophrenia, applied to similar symptoms in BPD, a practice not currently supported by NHMRC guidelines for BPD treatment. Participants were followed for a total of 27 weeks, with assessments on AVH severity, BPD symptoms, general psychopathology, functioning, and the experience of psychotic symptoms. The study also explored changes in the neurobiological mechanisms underlying AVHs as influenced by treatment.

The NEURAPRO-E Study: A multicenter Randomized Controlled Trial (RCT) of Omega-3 Fatty Acids and Cognitive-Behavioural Case Management for Symptomatic Patients at Ultra-High Risk for Early Progression to Schizophrenia and Other Psychotic Disorders to Assess the 6-month Transition Rate to First Episode Psychosis

Dataset derived from a clinical research study focusing on the early intervention in the prodromal phase of psychotic disorders, where individuals exhibit symptoms indicative of psychosis but not severe enough to constitute a full disorder. The study involved 320 patients identified as ‘ultra high risk’ (UHR) for developing psychotic disorders based on established criteria. Participants were randomized to receive either omega-3 fatty acids or a placebo, alongside a standard psychological treatment called cognitive behavioural case management (CBCM). CBCM combines elements of traditional case management with cognitive behavioural therapy, commonly used in clinical settings. The primary objective of this research was to evaluate whether omega-3 fatty acids, against a backdrop of CBCM, can lower the incidence of developing a psychotic disorder among these at-risk individuals.

REBOUND: Preventing relapse of major depressive disorder in youth: Randomised Controlled Trial of a novel mindfulness-based cognitive online social therapy

The study aims to evaluate, via a randomised controlled trial (RCT), the effectiveness of Rebound, a moderated online social networking system in preventing relapse of Major Depressive Disorder (MDD) in young people (aged 14-27) with remitted MDD. Rebound includes therapeutic activities and information about mental health, mindfulness, personal strengths, and other topics relevant for young people recovering from MDD. Rebound also includes a social network where participants can communicate via posts and comments in a newsfeed and a problem-solving forum. The social network will be moderated by experienced mental health workers and trained peer workers with lived experience of mental ill-health. Enhanced TAU includes access to a private website with information about depression symptoms, causes and course, the relationship between behaviour and mood, information on diet, exercise, sleep, social support and getting support. Enhanced TAU does not include therapist support or online social networking. The primary hypothesis of the study is that, relative to enhanced TAU, TAU plus Rebound will reduce relapse rates among remitted young people with MDD.

INVEST: Individualised vocational support for youth with borderline personality disorder: A randomised controlled trial

This single-blind, parallel-groups, randomised controlled trial evaluated the effectiveness of adding IPS to an evidence-based early intervention programme for Borderline Personality Disorder, with the aim of improving vocational outcomes. The randomisation is stratified by gender and age and uses random permuted blocks. The interventions are 39 weeks of either IPS, or ‘usual vocational services’ (UVS). Participants comprised of 108 help-seeking young people (aged 15-25 years) with three or more DSM-5 Borderline Personality Disorder features and a desire to study or work, recruited from the Helping Young People Early (HYPE) early intervention programme for Borderline Personality Disorder at Orygen, in Melbourne, Australia. All participants will receive the HYPE intervention. After baseline assessment, staff who are blind to the intervention group allocation will conduct assessments at 13, 26, 39 and 52 weeks. At the 52-week primary endpoint, the primary outcome is the number of days in mainstream education/employment since baseline. Secondary outcomes include the cost-effectiveness of the intervention, quality of life, and Borderline Personality Disorder severity.

Trialling the feasibility and acceptability of physical activity self-monitoring and supervised exercise interventions for adults with mental illness

This randomised controlled trial compared the effectiveness of two interventions to promote physical activity in adults with mental illness. The two interventions were; supervised exercise and gym membership, and motivational discussions and self-monitoring of PA using fitness trackers. The intervention duration was 16 weeks, including 8 weeks of weekly supervised group sessions, and 8 weeks of access to the gym or fitness tracker unsupervised. Participants are community-dwelling adults recruited from outpatient clinics of public mental health services. The primary outcome is physical activity adoption assessed using GENEActiv accelerometers worn continuously over 8 weeks. Secondary outcomes measured at baseline, postintervention (8 weeks) and follow-up (16 weeks), include exercise motivation, psychological distress and self-reported physical activity assessed using self-administered questionnaires and indicators of physical health measured by a researcher blinded to allocation (blood pressure, weight, waist circumference, 6 min walk test). Participant experiences will be assessed using qualitative focus groups with analysis informed by a theoretical model of behaviour (COM-B).

The Moo’D Study: A randomised controlled trial of A2 vs conventional dairy products in women with low mood.

This trial evaluated the comparative effects of consumption of dairy products containing A2 beta-casein versus conventional dairy (i.e. containing both A1 and A2 beta-casein) on symptoms of psychological distress in women with low mood. ‘The Moo’D Study’ is a 16-week, superiority, 1:1 parallel group, triple-blinded, randomised controlled trial. Ninety women with low mood (Patient Health Questionnaire score ≥ 5) will be randomised to consume either A2 beta-casein only or conventional dairy products. The primary outcome, symptoms of psychological distress, were measured by the 21-item Depression, Anxiety, and Stress Scale. Secondary outcomes include symptoms of depression, anxiety, and stress, severity of low mood, cognition, gut microbiota composition, gut symptomatology, markers of immune function, gut inflammation, systemic metabolites, endothelial integrity and oxidative stress, body composition, perceived wellbeing, sleep, quality of life, resource use and cost-effectiveness.

Human Microbiota Transfer Therapy for Depression (The “Moving Moods Pilot Study”)

The dataset assesses the feasibility and safety of fecal microbiota transplant (FMT) as an adjunctive treatment for major depressive disorder (MDD) in adults. Primary outcomes focus on feasibility measures, such as participant recruitment, adherence, and retention, alongside safety through adverse event tracking. Secondary outcomes evaluate shifts in gut microbiota composition (engraftment) and mental health symptoms using the Montgomery-Asberg Depression Rating Scale (MADRS) and Depression-Anxiety Stress Scale (DASS) at multiple timepoints. Additional variables capture quality of life (AQoL-8D), functional impairment (Sheehan Disability Scale), and physiological parameters like gut symptomatology (GSRS), inflammation markers, sleep quality (PSQI), and blood biomarkers. The dataset also includes cost-effectiveness data, comparing health sector and societal costs to analyze the economic impact of FMT in conjunction with traditional depression treatments.

Study of Ketamine for Youth Depression (SKY-D)

The primary aim of this research project is to determine if a 4-week course of low-dose subcutaneous ketamine is an effective treatment for young people (males and females aged 16-25 years) with moderate-to-severe depression. Participants will be randomised to receive either low-dose subcutaneous ketamine or a blinded control treatment that is therapeutically inactive (midazolam), given once a week for 4 weeks. Change in depression scores will be assessed at the end of the treatment phase at week 4, with further assessment at weeks 8 and 26 to assess whether treatment effects are sustained. It is hypothesised that ketamine will be an effective treatment for moderate-to-severe depression in young people.

Imagery-enhanced versus verbally-based group cognitive behavioural therapy for social anxiety disorder: a randomised controlled trial.

Imagery-based cognitive behavioural therapy (n = 53, 54.9% male) and verbally-based cognitive behavioural therapy (n = 54, 46.3% male) were administered, with 1 month (primary end-point) and 6 month follow up. Dataset includes diagnosis (social anxiety disorder), depression, generalised anxiety, social interaction anxiety scale (primary outcome), social phobia scale, and demographic information.

COPE-A: A randomised controlled trial of integrated psychological therapy for traumatic stress and substance use among adolescents aged 12-25 years

The dataset from the COPE-A trial captures detailed variables assessing the effects of trauma-focused cognitive-behavioral therapy on adolescents with PTSD and substance use issues. Core variables include DSM-5 diagnostic criteria for PTSD, measured through the Clinician-Administered PTSD Scale for Children and Adolescents (CAPS-CA-5), and substance dependence criteria assessed by the Diagnostic Interview Schedule for Children (DISC-5). Secondary variables track trauma-related cognitive changes (Child Post-Traumatic Cognitions Inventory, CPTCI) and emotional regulation (Emotion Regulation Questionnaire, ERQ-CA), with symptom severity and remission assessed at baseline, 4-month, and 12-month follow-ups. Additional variables monitor substance use patterns (Timeline Follow Back), distress tolerance (Distress Tolerance Scale), and self-compassion (SCS-SF). Measures of functional outcomes, therapeutic alliance (Working Alliance Inventory, WAI-SR), and client satisfaction (CSQ) are included, alongside adverse event reporting and session-specific changes in PTSD symptoms and cravings. This dataset enables a thorough analysis of clinical outcomes using DSM-5 criteria and other standardized measures across therapy sessions.

Youth Depression Alleviation: Augmentation with Anti-inflammatory Agent (YoDA-A)

This 12-week triple blind randomised controlled trial includes young people (15-25 years, 60% female) with moderate to severe major depressive disorder measured using the MADRS, recruited between 2013 and 2017 across Victoria, Australia. All participants received treatment as usual plus either aspirin (n = 40), rosuvastatin (n = 48) or placebo (n = 42) with assessments at baseline and weeks 4, 8, 12 and 26. Dataset includes primary outcome changes in the MADRS scale from baseline to 12 weeks, demographic information, suicidality, anxiety, substance use, and medication.

The efficacy of adjunctive Garcinia mangostana linn (mangosteen) pericarp for bipolar depression: A 24-week double-blind, randomised, placebo controlled trial.

This 24-week double-blind, randomized, placebo controlled efficacy trial evaluated the efficacy of adjunctive mangosteen pericarp, compared to placebo, in the treatment of schizophrenia. People diagnosed with schizophrenia or schizoaffective disorder (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), recruited across 2 sites (Brisbane and Victoria, Australia), were randomized to receive 24 weeks of adjunctive mangosteen pericarp (1,000 mg/day) or matched placebo. The primary outcome measure was the Positive and Negative Symptom Scale total score. Secondary outcomes included positive and negative symptoms, general psychopathology, clinical global severity and improvement, participant reported overall improvement, depressive symptoms, functioning, quality of life, and safety data at 24 and 28 weeks (4 weeks post discontinuation). Data were collected from July 2016 to February 2019.

Youth Depression Alleviation: A randomised controlled trial of omega-3 fatty acids (fish oil) for major depressive disorder in young people (YoDA-F)

This project tested the effectiveness of a 12-week parallel group, double-blind, randomized, placebo-controlled trial of 1.4 g day(-1) omega-3 PUFAs in help seeking 15- to 25-year-olds (N = 400) presenting with major depressive disorder.

YoDA-C: Youth Depression Alleviation: A Randomised Controlled Trial of Cognitive Behavioural Therapy with Fluoxetine or Placebo (YoDA-C)

Participants were aged 15-25 years with moderate to severe major depressive disorder. Participants were randomly assigned to receive cognitive behavioural therapy for 12 weeks, plus fluoxetine or placebo. Dataset includes demographic information, primary outcomes depression rating on the MADRS at baseline and 12 weeks, and other psychopathology information, including anxiety, substance use, suicidality, social and occupational functioning, quality of life, and satisfaction.

The CSC intervention: A comprehensive universal internet-based intervention to prevent anxiety, depression, substance use, and related harms in Australian adolescents aged 13 to 16 years.

Australian school students in grade 8 and 9 (aged 13-14 years, 52.1% male) were assigned to one of four groups: (1) Climate Schools–Substance Use, focusing on substance use only; (2) Climate Schools–Mental Health, focusing on depression and anxiety only; (3) Climate Schools–Combined, focusing on the prevention of substance use, depression, and anxiety; or (4) active control. Interventions were delivered for 2 years. Dataset includes primary outcomes of knowledge related to alcohol, cannabis, and mental health; alcohol use, including heavy episodic drinking; and depression and anxiety symptoms at 12, 24, and 30 months after baseline.

The CAP Study: Evaluating a comprehensive universal and targeted intervention designed to prevent substance use and related harms in Australian adolescents.

Dataset includes a total of 2190 students (mean age, 13.3 years. 57.% male) from 26 Australian high schools. Participants were followed up at 6 months, 1 year, 2 years, 3 years, 5.5 years, and 7 years. Schools were randomly assigned to deliver the following: (1) universal Web-based prevention for all students (Climate Schools); (2) selective prevention for high-risk students (Preventure); (3) combined universal and selective prevention (Climate Schools and Preventure [CAP]); or (4) health education as usual (control). Primary outcomes were self-reported frequency of alcohol consumption and binge drinking, alcohol-related harms, and hazardous alcohol use, at the 7-year follow-up.

Randomised controlled trial of a transdiagnostic online video-based intervention for reducing depression and anxiety in adults

Participants (n=1986) were screened for psychological distress, and then randomized to receive one of two 4-week programs: FitMindKit (12-module psychotherapy intervention) or HealthWatch (12-module program providing general health information). Participants were assessed at baseline and at 4 weeks post baseline. Data includes demographic information and psychopathology, including dperession, anxiety, panic, social phobia, and suicidality.

Can a tailored online program reduce mental health symptoms in adults?

The dataset from the “FitMindKit” trial includes variables assessing the efficacy of a tailored online program to reduce mental health symptoms in Australian adults with elevated, though subclinical, levels of depression, anxiety, suicidal ideation, or substance use. Key variables encompass demographic data and primary mental health outcomes, such as depression (PHQ-9), generalized anxiety (GAD-7), panic and social anxiety (PADIS, SOPHS), and substance use (AUDIT, DUDIT), recorded at post-test and three-month follow-up. Participants were randomized into one of three conditions: a tailored intervention targeting specific symptoms, a static version with general mental health modules, and an active control group focusing on general health information. Adherence metrics, including module completion rates and session engagement, as well as satisfaction scores, are included as secondary outcomes. Cost-effectiveness, attrition rates, and participant satisfaction with the program are also captured, supporting an analysis of the intervention’s impact on mental health symptoms and engagement levels across conditions. This dataset enables a robust comparison of tailored versus general mental health interventions using standardized assessments across multiple timepoints.

Increasing engagement with online programs to improve mental health in the community: The Engagement Project

This 3-arm randomized controlled trial (N=849, 76.1% female, aged 18-66+) assessed the independent efficacy of the engagement facilitation interventions and myCompass 2 program. The myCompass 2 program was delivered with or without the engagement facilitation interventions; both conditions were compared with an attention control condition. Data includes demographic information and psychopathology (anxiety, depression, Quality of Life, and suicidality).

Treatment of clozapine associated obesity and diabetes with exenatide in people with schizophrenia

Twenty-eight outpatients with schizophrenia (aged 18-64 years) were randomized to once-weekly extended-release subcutaneous exenatide or usual care for 24 weeks. The primary outcome was proportion of participants with >5% weight loss. All 28 participants completed the study; 3/14 in the exenatide group and 2/14 in the usual care group had type 2 diabetes.

Combating disordered eating and poor body image with the use of imagery rescripting among young women at risk of developing an eating disorder

The dataset from the trial includes variables assessing the effectiveness of imagery rescripting (IR) and psychoeducation interventions among young women at risk of developing eating disorders. Primary outcomes focus on global eating psychopathology (EDE-Q) and body image acceptance (BI-AAQ), measured at baseline and one-week follow-up. Secondary outcomes include self-compassion (SCS-SF), fear of self-compassion (FSC), and dysfunctional attitudes (DAS-SF1), along with confidence in changing disordered eating behaviors. Participants were assigned to one of four conditions: body-focused IR, general IR, psychoeducation, or control. The IR conditions involved three steps—reliving, observing, and rescripting specific memories—allowing for comparisons between body-specific and general rescripting approaches. This dataset enables analysis of how targeted interventions impact disordered eating risk factors and self-perception in young women.