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Developing a screening tool to predict who will benefit from online-assisted treatment for depression and anxiety among tertiary students.

A randomised controlled trial of online group Cognitive Behavioural Therapy (CBT), guided eCBT, and unguided eCBT for symptoms of depression and anxiety among tertiary students in Aotearoa, New Zealand

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000209594
Enrollment
101
Registered
2024-03-01
Start date
2024-03-21
Completion date
2025-09-01
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Using a pragmatic RCT we will test three, internet delivered CBT-based treatments for depression and anxiety (iGroup, a 10-week online group intervention; iStandard self-guided modules online; and iCoach, self-guided modules plus asynchronous coach support via text) compared with treatment as usual. We will recruit rangatahi (young people) enrolled in tertiary education. Beyond evaluating which therapy works best overall for Maori and non-Maori, we will use machine learning techniques to develop a precision treatment rule to understand who is most likely to respond to which treatment.

Interventions

1) iStandard: Online CBT-based self-guided modules, 4-12 modules 2) iCoach: The same online CBT-based self-guided modules as delivered in iStandard with the same instructions but with the addition of asynchronous, text-based coach support, For iStandard and iCoach, participants can select from among the same modules to suit their needs. Modules are transdiagnostic "bundled" by theme to address common student challenges: (1) Stress; 2) Mood; 3) Life skills including self-esteem, emotional wellb

1) iStandard: Online CBT-based self-guided modules, 4-12 modules 2) iCoach: The same online CBT-based self-guided modules as delivered in iStandard with the same instructions but with the addition of asynchronous, text-based coach support, For iStandard and iCoach, participants can select from among the same modules to suit their needs. Modules are transdiagnostic "bundled" by theme to address common student challenges: (1) Stress; 2) Mood; 3) Life skills including self-esteem, emotional wellbeing, study skills, and social life; 4) Procrastination; 5) Self-esteem. Bundles contain 4-12 modules. Module content includes stress management, whai tikanga, cognitive restructuring, behavioural activation, assertiveness, sleep, exercise, problem solving, procrastination and time management, instant relaxation techniques, goal setting, and breathing exercises. The programmes use videos, text, and infographics. Participants are asked to write about their emotional, cognitive, and behavioural responses and coping strategies as they work through the modules. Each session lasts approximately 60 minutes and participants are advised to complete one module every week but they are able to complete them at their discretion. In iCoach, after each module, a coach provides asynchronous feedback on-line. Students are also able to write messages to their coach. Coach support is available for three months from enrollment; module content for iStandard and iCoach is available for 12 months from enrollment. The online platform sends personalised reminders to participants to complete sessions if they have not engaged within the past fortnight. The platform is optimised for use on either smart phones or personal computers. Technical support will be available through email and phone support, which improves adherence. Module completion will be recorded to monitor adherence. Module content was developed by our collaborators in the Netherlands at Vrije University Amsterdam and adapted by our research team, for this study, for use in Aotearoa NZ. 3) iGroup: Online CBT-based psychological skills groups, Five 2 hour modules (delivered weekly over 10 weeks in 60 minute sessions via Zoom) covering: 1.1 Emotional triggers and automatic thoughts 1.2 Challenge automatic thoughts and core beliefs 2.1 Recognise stressors and use strategies to solve interpersonal and emotional problems 2.2 Goal setting and planning 3.1 Avoiding thinking traps 3.2 Overcoming rumination and guilt 4.1 Behaviour activation 4.2 Whai tikanga and behaviours that matter 5.1 The body’s stress response and how to use strategies to regulate physiological arousal 5.2 Managing stress and overcoming avoidance Group participants are provided with a workbook, which covers the content covered in the interactive group session. Participants are able to keep their camera turned off and use a pseudonym during the session for anonymity, but are encouraged to turn their camera on as they become comfortable. Information is presented by the group facilitator and then participants are asked questions, which they can discuss with other group members in a break-out room or with the whole group depending on the size of the group and the nature of the questions. For example, in Workshop A.1 Emotional Triggers and Automatic Thoughts, participants are asked to consider and then discuss what they think can cause depression and anxiety, what causes are easy to change, how do people interact with others when they are feeling sad or anxious - how do the feelings affect their behaviour, Information is then presented by the facilitator about the thoughts, feelings, behaviours triangle, Next a case scenario is presented for the participants to consider and to discuss the thoughts the person in the case might have and then how that might affect the person's feelings. At the end of the session, participants are encouraged to keep a daily record of their thoughts and feelings over the coming week. The group content was created by our collaborators in South Africa and adapted for use in this study. Group facilitators will have completed the 5th year of a Clinical Psychology training programme and will be supervised by a registered clinical psychologist. Group attendance will be recorded to monitor adherence. Group size will not exceed 12 participants. Every treatment arm is targeted to the treatment of depression and anxiety symptoms and all content was developed considering the specific needs of student participants e.g., case study examples are students with common student challenges.

Sponsors

University of otago
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

At least 18 years of age, screens positive for major depressive disorder and/or generalized anxiety disorder, student enrolled in one of the participating tertiary sites

Exclusion criteria

Screens positive for bipolar disorder, screens positive for psychosis, active suicidality

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026