Administrative information
Title (1) | Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial |
Trial registration (2a and 2b) | 2b. The trial is registered at clinicaltrials.gov. All items for the WHO TRDS can be found in that protocol, with the exception of key secondary outcomes, which are described in Table 2 in this research protocol. |
Protocol version (3) | January 30, 2024 |
Funding (4) | The study is funded by Swedish Research Council grant number 2019–01127 to the first author. |
Author details (5a) | 1Department of Psychology, Uppsala University, Uppsala, Sweden 2 Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, & Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden 3Department of Behavioural Sciences and Learning, Department of Biomedical and Clinical Sciences, Linköping University 4 Department of Psychology, Stockholm University, Stockholm, Sweden 5 Department of Health, Medicine and Caring Sciences, Linköping University 6 Department of Global Public Health, Karolinska Institutet 7 Department of Criminology, Malmö University, Malmö, Sweden |
Name and contact information for the trial sponsor (5b) | Swedish Research Council, https://www.vr.se/english.html |
Role of sponsor (5c) | The funding agency has had no role in the design of the study, nor will they have any involvement in collection, analysis and interpretation of data, and writing of manuscripts. |
Introduction
Background and rationale (6a)
Objectives (7)
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Recruit up to 1200 eligible university students.
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Include students with mild to moderate, syndromal, and sub-syndromal symptoms of depression and/or anxiety symptoms, following brief baseline screening.
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Randomize included individuals to guided or unguided treatment, or to a waitlist control group accessing treatment 6 months after randomization.
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Collect weekly data on symptoms of depression, anxiety, and well-being during the 8-week treatment period.
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In week 3 of 8, to identify participants in the guided and unguided treatment arms, who indicate lack of improvement or worsened symptoms and to randomize them within a SWAT to an adaptive treatment strategy (ATS) or to continue as per their original randomization.
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Follow up students at post-treatment and at 6-, 12-, and 24-months post-randomization.
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Undertake qualitative evaluation of students’ experiences of the specific internet treatment received, including those randomized to unguided treatment and those randomized to the ATS.
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Statistically, we aim to compare primary outcomes between treatment arms, namely treatment effects on syndromal and sub-syndromal depression and anxiety, in relation to the primary hypothesis that both guided and unguided groups will show superior moderate-sized overall effects compared to the waitlist control group, and the secondary hypothesis assumes that the guided group will show no differences in effects in relation to the unguided group.
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Statistically, we will also compare primary outcomes for individuals in the guided and unguided treatment arms, who participated in the embedded SWAT, in relation to the hypothesis that those who received an ATS will show improved small to moderate effects in comparison to those who did not receive an ATS. A secondary hypothesis regarding the SWAT is that trial retention will be higher for individuals who received an ATS, in comparison to those did not.
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We will also conduct additional statistical evaluations, comparing secondary outcomes for the main and SWAT trials, with identical hypotheses to those formulated for the primary outcomes.
Trial design (8)
Methods: participants, interventions and outcomes
Study setting (9)
Eligibility criteria (10)
Who will take informed consent? (26a)
Additional consent provisions for collection and use of participant data and biological specimens (26b)
Interventions
Explanation for the choice of comparators (6b)
Intervention description (11a)
Week | Module type | Theme | Title |
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1a. Overview | |||
1 | Standarda | Psychoeducation | It’s about you |
2 | Track choiceb | Behavioral activation I | Map your activities |
2 | Track choiceb | Anxiety and GAD | Anxiety and constant worry |
3 | Track choiceb | Behavioral activation II | Change through action |
3 | Track choiceb | Anxiety and exposure | Anxiety |
4 | Tailored choicec | Rank #1 | |
5 | Tailored choicec | Rank #2 | |
6 | Tailored choicec | Rank #3 | |
7 | Standarda | Acceptance | Acceptance |
8 | Standarda | Maintenance | Continue to take care of yourself |
1b. Tailored choice. All elective module options are presented to participants at the start of their treatment program. The participant then ranks the top three preferences. | |||
N/A | Tailored choicec | Emotion and affect regulation | Everything we feel |
N/A | Tailored choicec | Cognitive restructuring | Change your thoughts |
N/A | Tailored choicec | Stress management | Manage stress |
N/A | Tailored choicec | Relaxation | Relaxation |
N/A | Tailored choicec | Sleep hygiene | Change your sleep |
N/A | Tailored choicec | Social anxiety | Anxiety and social contact |
N/A | Tailored choicec | Panic anxiety | Anxiety and panic |
N/A | Tailored choicec | Perfectionism | Being perfect? |
Procedure for inclusion in the SWAT
Nr | Phase | Category | Construct | Instrument | T0 Tx eligibility assessment | T1 Pre-Tx Assessment | Weekly during Tx | T2 Mid-Tx after 3rd Tx module | T3 End of Tx (8 w) | T4 6 m follow-up | T5 12 m follow-up | T6 24 m follow-up |
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1 | Screen | Mental health | Demographic / mental health screen | WHO-WMH-ICS | Data from 1st term | 3rd term | 5th term | |||||
1.1 | Information | Referral | Referral | Resources | √ | |||||||
2 | Screen | Tx now? | Exclusion | 3 Qs | √ | |||||||
2.1 | Screen | Mental health | Co-morbidity | DSM-5 CCSM + | √ | √ | √ | √ | √ | √ | ||
3 | Screen/Weekly/ primary outcome | Mental health | Depression | PHQ-9 | √ | √ | √ | √ | √ | √ | √ | √ |
4 | Screen/Weekly/ primary outcome | Mental health | Anxiety | GAD-7 | √ | √ | √ | √ | √ | √ | √ | √ |
5 | Screen (as long as relevant) | Mental health | Pandemic-related anxiety | GAD-7COVID | √ | |||||||
6 | Screen + all phases | Wellbeing | Well-being | WHO-5 | √ | √ | √ | √ | √ | √ | √ | √ |
7 | Pre-Tx | Tx prep | Motivational component | Telephone interview | √ | |||||||
8 | Pre-Tx | Tx prep | Tx expectancy | CEQ | √ | √ | ||||||
9 | Pre-Tx | Tx prep | Attitudes towards professional help | ATSPPHS | √ | √ | √ | |||||
10 | Mid-Tx assessment | Risk factor | Risk factor Sleep | ISI | √ | √ | √ | √ | √ | √ | ||
11 | Mid-Tx assessment | Skill | Behavioral Activation Depression | BADS | √ | √ | √ | √ | √ | √ | ||
12 | Mid-Tx assessment | Skill | Managing negative thoughts | SOCT-P | √ | √ | √ | √ | ||||
13 | Mid-Tx assessment | Txprocess | Tx alliance | WAI-SR for internet Tx | √ | √ | ||||||
14 | Secondary outcome | Wellbeing | Quality of life | WHOQOLBref | √ | √ | √ | |||||
15 | Secondary outcome | Risk factor | Alcohol | AUDIT-C | √ | √ | √ | √ | √ | |||
16 | Secondary outcome | Risk factor | Risk factor Self-esteem | RSES | √ | √ | √ | √ | √ | |||
17 | Secondary outcome | Risk factor | Risk factor Resilience | CD-RISC-25 | √ | √ | √ | √ | √ | |||
18 | Secondary outcome | Risk factor | Emotion regulation | DERS-16 | √ | √ | √ | √ | √ | |||
19 | Secondary outcome | Risk factor | Worry | PSWQ | √ | √ | √ | √ | √ | |||
20 | Secondary outcome | Risk factor | Personality | BFI-10 | √ | √ | √ | |||||
21 | Secondary outcome | Health econ | Other help accessed | TIC-P | √ | √ | √ | √ | ||||
22 | Secondary outcome | Txprocess | Tx satisfaction | CSQ | √ (22.1) | √ | √ | √ | ||||
23 | Secondary outcome | Txprocess | Tx negative effects | NEQ | √ | √ | √ | √ | ||||
24 | Qualitative study | Txprocess | Interview guide | Qual interview | √ |
Qualitative interviews
Criteria for discontinuing or modifying allocated interventions (11b)
Strategies to improve adherence to interventions (11c)
Relevant concomitant care permitted or prohibited during the trial (11d)
Provisions for post-trial care (30)
Outcomes (12)
Primary outcome
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Anxiety, which will be measured using GAD-7 (total score).
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Depression, which will be measured using PHQ-9 (total score).
Secondary outcomes
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Externally and behaviorally oriented outcomes
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Alcohol consumption, which will be measured using AUDIT-C (T3-T6).
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Comorbidity, which will be measured using DSM-5 CCSM (T3-T6).
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Resilience, which will be measured using CD-RISC-25 (T3-T6).
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Sleep, which will be measured using ISI (T3-T6).
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Well-being, which will be measured using WHO-5 (T3-T6).
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Internally oriented outcomes
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Emotional regulation, which will be measured using DERS-16 (T3-T6).
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Personality, which will be measured using BFI-10 (T3-T6).
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Self-esteem, which will be measured using RSES (T3-T6).
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Worry, which will be measured using PSWQ (T3-T6).
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Mediator outcomes
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Behavioral activation-depression, measured using BADS (T2-T3).
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Behavioral activation-depression, measured using BADS (T2-T3).
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Participant timeline (13)
Sample size (14)
Recruitment (15)
Assignment of interventions: allocation
Sequence generation (16a)
Concealment mechanism (16b)
Implementation (16c)
Assignment of interventions: blinding
Who will be blinded (17a)
Procedure for unblinding if needed (17b)
Data collection and management
Plans for assessment and collection of outcomes (18a)
Plans to promote participant retention and complete follow-up (18b)
Data management (19)
Confidentiality (27)
Analysis
Statistical methods for primary and secondary outcomes (20a)
Interim analyses (21b)
Methods for additional analyses (e.g., subgroup analyses) (20b)
Mediator models
Ancillary analyses
SWAT analyses
Exploratory analyses
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A process evaluation of the interventions, including participants’ experiences of support, treatment expectancies, satisfaction and alliance, and any negative treatment effects. Specific treatment process outcomes for all RCT participants include treatment expectancy (CEQ), attitudes towards professional help (ATSPPHS), treatment alliance (WAI-SR for Internet treatment), treatment satisfaction (CSQ), and negative effects of treatment (NEQ); see Table 2.
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Treatment process is also measured in terms of completed treatment modules and % of completed skills practices. Trial process outcomes for all RCT participants concern adherence.
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To the assessment plan, measured in terms of % completed measures at post-treatment; SWAT adherence measures include % of participants who are randomized to receive additional therapist support for the remainder of the treatment period (weeks 4 to 8). For participants who have given their consent in the preceding WHO-WMH-ICS survey, secondary outcomes will also include annual data on students’ academic records via LADOK, the Swedish national documentation system of higher education outcomes, specifically academic success, changes in academic study focus, or interruption of studies. Qualitative interviews concerning experience of treatment outcome and treatment-seeking pathways will complement secondary outcome measurement.
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Additional trial process-related outcomes include overall treatment interest and uptake, measured in terms of the percentage (%) of participants who respond to the study invitation (interest) as well as participate in treatment (uptake).
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An analysis of primary outcomes using all measures from all assessments during the intervention period, and follow-up data, with time modeled as numeric rather than categorical as in the primary analyses (with and without quadratic term for time).