Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment: study protocol for a pragmatic cluster randomised controlled trial (GET Sleep)
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Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment : study protocol for a pragmatic cluster randomised controlled trial (GET Sleep). / Spiegelhalder, Kai; Baumeister, Harald; Al-Kamaly, Abdulwahab et al.
In: BMJ Open, Vol. 12, No. 8, e058212, 01.08.2022.Research output: Journal contributions › Journal articles › Research › peer-review
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TY - JOUR
T1 - Comparative effectiveness of three versions of a stepped care model for insomnia differing in the amount of therapist support in internet-delivered treatment
T2 - study protocol for a pragmatic cluster randomised controlled trial (GET Sleep)
AU - Spiegelhalder, Kai
AU - Baumeister, Harald
AU - Al-Kamaly, Abdulwahab
AU - Bader, Martina
AU - Bauereiss, Natalie
AU - Benz, Fee
AU - Braun, Lina
AU - Buntrock, Claudia
AU - Burkhardt, Maike
AU - Cuijpers, Pim
AU - Domschke, Katharina
AU - Dülsen, Patrick
AU - Franke, Marvin
AU - Frase, Lukas
AU - Heber, Elena
AU - Helm, Kathrin
AU - Jentsch, Terry
AU - Johann, Anna
AU - Küchler, Ann Marie
AU - Kuhn, Michael
AU - Lehr, Dirk
AU - Maun, Andy
AU - Morin, Charles M.
AU - Moshagen, Morten
AU - Richter, Kneginja
AU - Schiel, Julian
AU - Simon, Laura
AU - Spille, Lukas
AU - Weeß, Hans Günter
AU - Riemann, Dieter
AU - Ebert, David Daniel
N1 - Publisher Copyright: ©
PY - 2022/8/1
Y1 - 2022/8/1
N2 - INTRODUCTION: It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.
AB - INTRODUCTION: It is unclear how internet-delivered cognitive-behavioural therapy for insomnia (CBT-I) can be integrated into healthcare systems, and little is known about the optimal level of therapist guidance. The aim of this study is to investigate three different versions of a stepped care model for insomnia (IG1, IG2, IG3) versus treatment as usual (TAU). IG1, IG2 and IG3 rely on treatment by general practitioners (GPs) in the entry level and differ in the amount of guidance by e-coaches in internet-delivered CBT-I. METHODS AND ANALYSIS: In this randomised controlled trial, 4268 patients meeting International Classification of Diseases, Tenth Revision (ICD-10) criteria for insomnia will be recruited. The study will use cluster randomisation of GPs with an allocation ratio of 3:3:3:1 (IG1, IG2, IG3, TAU). In step 1 of the stepped care model, GPs will deliver psychoeducational treatment; in step 2, an internet-delivered CBT-I programme will be used; in step 3, GPs will refer patients to specialised treatment. Outcomes will be collected at baseline, and 4 weeks, 12 weeks and 6 months after baseline assessment. The primary outcome is insomnia severity at 6 months. An economic evaluation will be conducted and qualitative interviews will be used to explore barriers and facilitators of the stepped care model. ETHICS AND DISSEMINATION: The study protocol was approved by the Ethics Committee of the Medical Centre-University of Freiburg. The results of the study will be published irrespective of the outcome. TRIAL REGISTRATION NUMBER: DRKS00021503.
KW - Adult psychiatry
KW - PSYCHIATRY
KW - SLEEP MEDICINE
KW - Health sciences
KW - Psychology
UR - http://www.scopus.com/inward/record.url?scp=85135501727&partnerID=8YFLogxK
UR - https://www.mendeley.com/catalogue/fda834be-d9ff-315a-ae9c-d37c8721bf57/
U2 - 10.1136/bmjopen-2021-058212
DO - 10.1136/bmjopen-2021-058212
M3 - Journal articles
C2 - 35922096
AN - SCOPUS:85135501727
VL - 12
JO - BMJ Open
JF - BMJ Open
SN - 2044-6055
IS - 8
M1 - e058212
ER -