TY - JOUR
T1 - Online computer or therapist-guided cognitive behavioral therapy in university students with anxiety and/or depression
T2 - study protocol of a randomised controlled trial
AU - Klein, A.
AU - Wolters, N.E.
AU - Bol, E.J.M.
AU - Koelen, J.
AU - de Koning, L.
AU - Roetink, S.S.M.
AU - van Blom, J.J.
AU - Pronk, T.
AU - van der Heijde, C.
AU - Salemink, E.
AU - Bolinski, F.
AU - Riper, H.
AU - Karyotaki, E.
AU - Cuijpers, P.
AU - Schneider, S
AU - Rapee, R.M.
AU - Vonk, P.
AU - Wiers, R.W.
N1 - Funding Information:
Funding This work was supported by a grant from the University of Amsterdam (Spui 21, 1012GC,+31205251400) awarded to AK (Co-PI), PV (PI; [email protected]; Oude Turfmarkt 151, 1012LA, Amsterdam, University of Amsterdam), CvdH (Co-PI) and RWW (PI; [email protected]; Nieuwe achtergracht 129, 1001NK, Amsterdam, University of Amsterdam). Award/grant number non-applicable. A steering group from the University of Amsterdam monitors the processes of the entire trial and approves mid-term evaluation.
Publisher Copyright:
© 2021 BioMed Central Ltd.. All rights reserved.
PY - 2021/11/26
Y1 - 2021/11/26
N2 - Introduction Emerging adulthood is a phase in life that is associated with an increased risk to develop a variety of mental health disorders including anxiety and depression. However, less than 25% of university students receive professional help for their mental health reports. Internet-based cognitive behavioural therapy (iCBT) may entail useful interventions in a format that is attractive for university students. The aim of this study protocol is to test the effectiveness of a therapist-guided versus a computer-guided transdiagnostic iCBT programme with a main focus on anxiety and depression. Methods and analysis University students with anxiety and/or depressive symptoms will be randomised to a (1) 7-week iCBT programme (excluding booster session) with therapist feedback, (2) the identical iCBT programme with computer feedback only or (3) care as usual. Participants in the care as usual condition are informed and referred to conventional care services and encouraged to seek the help they need. Primary outcome variables are self-reported levels of anxiety as measured with the General Anxiety Disorder-7 and self-reported levels of depression as measured with the Patient Health Questionnaire-9. Secondary outcomes include treatment adherence, client satisfaction, medical service use, substance use, quality of life and academic achievement. Assessments will take place at baseline (t1), midtreatment (t2), post-treatment (t3), at 6 months (t4) and 12 months (t5) postbaseline. Social anxiety and perfectionism are included as potentially important predictors of treatment outcome. Power calculations are based on a 3 (group) × 3 (measurement: pretreatment, midtreatment and post-treatment) interaction, resulting in an aimed sample of 276 participants. Data will be analysed based on intention-to-treat and per protocol samples using mixed linear models.
AB - Introduction Emerging adulthood is a phase in life that is associated with an increased risk to develop a variety of mental health disorders including anxiety and depression. However, less than 25% of university students receive professional help for their mental health reports. Internet-based cognitive behavioural therapy (iCBT) may entail useful interventions in a format that is attractive for university students. The aim of this study protocol is to test the effectiveness of a therapist-guided versus a computer-guided transdiagnostic iCBT programme with a main focus on anxiety and depression. Methods and analysis University students with anxiety and/or depressive symptoms will be randomised to a (1) 7-week iCBT programme (excluding booster session) with therapist feedback, (2) the identical iCBT programme with computer feedback only or (3) care as usual. Participants in the care as usual condition are informed and referred to conventional care services and encouraged to seek the help they need. Primary outcome variables are self-reported levels of anxiety as measured with the General Anxiety Disorder-7 and self-reported levels of depression as measured with the Patient Health Questionnaire-9. Secondary outcomes include treatment adherence, client satisfaction, medical service use, substance use, quality of life and academic achievement. Assessments will take place at baseline (t1), midtreatment (t2), post-treatment (t3), at 6 months (t4) and 12 months (t5) postbaseline. Social anxiety and perfectionism are included as potentially important predictors of treatment outcome. Power calculations are based on a 3 (group) × 3 (measurement: pretreatment, midtreatment and post-treatment) interaction, resulting in an aimed sample of 276 participants. Data will be analysed based on intention-to-treat and per protocol samples using mixed linear models.
UR - http://www.scopus.com/inward/record.url?scp=85114821857&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2021-049554
DO - 10.1136/bmjopen-2021-049554
M3 - Review article
C2 - 34836897
SN - 2044-6055
VL - 11
SP - 1
EP - 10
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e049554
ER -