Internet-guided cognitive, behavioral and chronobiological interventions in depression-prone insomnia subtypes: protocol of a randomized controlled prevention trial.
Chronobiological therapy
Cognitive behavioral therapy for insomnia
Depression
Insomnia
Randomized controlled trial
Journal
BMC psychiatry
ISSN: 1471-244X
Titre abrégé: BMC Psychiatry
Pays: England
ID NLM: 100968559
Informations de publication
Date de publication:
15 04 2020
15 04 2020
Historique:
received:
17
09
2019
accepted:
18
03
2020
entrez:
16
4
2020
pubmed:
16
4
2020
medline:
22
12
2020
Statut:
epublish
Résumé
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. 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. 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. Netherlands Trial Register (NL7359). Registered on 19 October 2018.
Sections du résumé
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.
Identifiants
pubmed: 32293363
doi: 10.1186/s12888-020-02554-8
pii: 10.1186/s12888-020-02554-8
pmc: PMC7160982
doi:
Types de publication
Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
163Subventions
Organisme : European Research Council
ID : ERC-ADG-2014-671084 INSOMNIA
Pays : International
Organisme : European Research Council
ID : ERC-2016-PoC-737634 INSOMNIA BEAT IT
Pays : International
Organisme : VU University Amsterdam
ID : University Research Fellowship
Pays : International
Organisme : VU University Amsterdam
ID : University Research Fellowship
Pays : International
Organisme : VU University Amsterdam
ID : University Research Fellowship
Pays : International
Organisme : VU University Amsterdam
ID : University Research Fellowship
Pays : International
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