Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial

Berman, Anne H.; Topooco, Naira; Lindfors, Petra; Bendtsen, Marcus; Lindner, Philip; Molander, Olof; Kraepelien, Martin; Sundström, Christopher; Talebizadeh, Nooshin; Engström, Karin; Vlaescu, George; Andersson, Gerhard; Andersson, Claes

doi:10.1186/s13063-024-07986-1

Trials

Table 2 Overview of instruments used in treatment (Tx) RCT Sweden. Inspired by Weisel et al. 2019 [36]. All followups are timed from the point of pre-Tx randomization

From: Transdiagnostic and tailored internet intervention to improve mental health among university students: Research protocol for a randomized controlled trial

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
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						√

Instrument abbreviations
1. WHO-WMH-ICS survey World Mental Health-College Student Inititative Survey
2. DSM-5 Level 1 CCSM Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (26 items), American Psychiatric Assoc. [31, 32]
3. PHQ-9 Patient Health Questionnaire (9 items), Kroenke et al. 2001 [29]
4. GAD-7 General Anxiety Disorder questionnaire (7 items), Spitzer et al. 2006 [30]
5. GAD-7- COVID GAD-7 adapted for COVID-19 pandemic, Wahlund et al., 2020 [37]
6. WHO-5 World Health Organization Well-being questionnaire (5 items), Topp et al. 2015 [38]
7. Telephone interview Research group’s original guide based on student user input (Berman, Granlund, Molander et al., 2021, unpublished)
8. CEQ Credibility-Expectancy Questionnaire (5 items), Devilly & Borkovec 2000 [39]
9. ATSPPHS Attitudes towards seeking professional psychological help scale (10 items), Surgenor, 1985 [40]
10. ISI Insomnia Severity Index (7 items), Morin et al., 2011 [41]
11. BADS Behavioral Activation for Depression Scale (25 items), Kanter et al. 2007, 2010 [42, 43]
12. SOCT-P Skills of Cognitive Therapy – Patient/participant version (8 items), Jarrett et al., 2011[44]
13. WAI-SR adapted for internet Working Alliance Inventory – Self-Report (12 items) Tracey & Kokotowitc 1989 [45]
14. WHOQOL-Bref World Health Organization Quality of Life Scale – Brief (26 items), Skevington et al., 2004 [46]
15. AUDIT-C Alcohol Use Disorders Identification Test – Consumption (3 items), Bush et al. 1998 [47]
16. RSES Rosenberg Self-Esteem Scale (10 items), Rosenberg, 1979; [48, 49]
17. 1CD-RISC-25 Connor-Davidson Resilience Scale (25 items), Connor-Davidson et al. 2003; Velickovic et al. 2020 [50, 51], permission granted
18. DERS-16 Difficulties in Emotion-Regulation Scale (16 items), Swedish version Bjureberg et al., 2015 [52]
19. PSWQ Penn-State Worry Questionnaire (16 items), Berle et al., 2011, Swedish version, E Andersson, E Hedman et al. 2017 [53, 54]
20. BFI-10 Big Five Inventory-10 (10 items), Rammstedt & John, 2007 [55]
21. TIC-P Healthcare consumption and productivity loss in patients with a psychiatric disorder (56 items); Bouwmans et al., 2013 [56]
22. CSQ Client Satisfaction Questionnaire (8 items), Attkisson & Zwick 1982 [57]
22.1. CSQ, adapted Client Satisfaction Questionnaire (8 items), adapted for mid-Tx assessment
23. NEQ Negative treatment effects questionnaire (20 items), Rozental et al. 2019 [58]
24. Qualitative interview Qualitative interview on experience of treatment intervention

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