TY - JOUR
T1 - Internet-guided cognitive, behavioral and chronobiological interventions in depression-prone insomnia subtypes
T2 - protocol of a randomized controlled prevention trial
AU - Leerssen, Jeanne
AU - Foster-Dingley, Jessica C
AU - Lakbila-Kamal, Oti
AU - Dekkers, Laura M S
AU - Albers, Anne C W
AU - Ikelaar, Savannah L C
AU - Maksimovic, Teodora
AU - Wassing, Rick
AU - Houtman, Simon J
AU - Bresser, Tom
AU - Blanken, Tessa F
AU - Te Lindert, Bart
AU - Ramautar, Jennifer R
AU - Van Someren, Eus J W
PY - 2020
Y1 - 2020
N2 - BACKGROUND: Major depressive disorder is among the most burdening and costly chronic health hazards. Since its prognosis is poor and treatment effectiveness is moderate at best, prevention would be the strategy of first choice. Insomnia may be the best modifiable risk factor. Insomnia is highly prevalent (4-10%) and meta-analysis estimates ±13% of people with insomnia to develop depression within a year. Among people with insomnia, recent work identified three subtypes with a particularly high lifetime risk of depression. The current randomized controlled trial (RCT) evaluates the effects of internet-guided Cognitive Behavioral Therapy for Insomnia (CBT-I), Chronobiological Therapy (CT), and their combination on insomnia and the development of depressive symptoms.METHODS: We aim to include 120 participants with Insomnia Disorder (ID) of one of the three subtypes that are more prone to develop depression. In a two by two factorial repeated measures design, participants will be randomized to CBT-I, CT, CBT-I + CT or treatment as usual, and followed up for one year. The primary outcome is the change, relative to baseline, of the severity of depressive symptoms integrated over four follow-ups spanning one year. Secondary outcome measures include a diagnosis of major depressive disorder, insomnia severity, sleep diaries, actigraphy, cost-effectiveness, and brain structure and function.DISCUSSION: Pre-selection of three high-risk insomnia subtypes allows for a sensitive assessment of the possibility to prevent the development and worsening of depressive symptoms through interventions targeting insomnia.TRIAL REGISTRATION: Netherlands Trial Register (NL7359). Registered on 19 October 2018.
AB - BACKGROUND: Major depressive disorder is among the most burdening and costly chronic health hazards. Since its prognosis is poor and treatment effectiveness is moderate at best, prevention would be the strategy of first choice. Insomnia may be the best modifiable risk factor. Insomnia is highly prevalent (4-10%) and meta-analysis estimates ±13% of people with insomnia to develop depression within a year. Among people with insomnia, recent work identified three subtypes with a particularly high lifetime risk of depression. The current randomized controlled trial (RCT) evaluates the effects of internet-guided Cognitive Behavioral Therapy for Insomnia (CBT-I), Chronobiological Therapy (CT), and their combination on insomnia and the development of depressive symptoms.METHODS: We aim to include 120 participants with Insomnia Disorder (ID) of one of the three subtypes that are more prone to develop depression. In a two by two factorial repeated measures design, participants will be randomized to CBT-I, CT, CBT-I + CT or treatment as usual, and followed up for one year. The primary outcome is the change, relative to baseline, of the severity of depressive symptoms integrated over four follow-ups spanning one year. Secondary outcome measures include a diagnosis of major depressive disorder, insomnia severity, sleep diaries, actigraphy, cost-effectiveness, and brain structure and function.DISCUSSION: Pre-selection of three high-risk insomnia subtypes allows for a sensitive assessment of the possibility to prevent the development and worsening of depressive symptoms through interventions targeting insomnia.TRIAL REGISTRATION: Netherlands Trial Register (NL7359). Registered on 19 October 2018.
U2 - 10.1186/s12888-020-02554-8
DO - 10.1186/s12888-020-02554-8
M3 - Article
C2 - 32293363
SN - 1471-244X
VL - 20
SP - 163
JO - BMC Psychiatry
JF - BMC Psychiatry
IS - 1
ER -