Imagine your mood: Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression

Christien Slofstra; Nicola S. Klein; Maaike H. Nauta; Marieke Wichers; Nikolaos Batalas; Claudi L.H. Bockting

doi:10.1016/j.conctc.2017.07.003

Imagine your mood: Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression

Christien Slofstra, Nicola S. Klein, Maaike H. Nauta, Marieke Wichers, Nikolaos Batalas, Claudi L.H. Bockting

Research output: Contribution to journal › Article › Academic › peer-review

8 Citations (Scopus)

319 Downloads (Pure)

Abstract

Background
Relapse prevention strategies include continuation of antidepressant medication and preventive psychological interventions. This study aims to gain understanding that may inform tailoring of relapse prevention to individual differences, to improve their effects. Such treatment personalization may be based on repeated assessments within one individual, using experience sampling methodology. As a first step towards informing decisions based on this methodology, insight is needed in individual differences in risk of relapse and response to treatment, and how relapse prevention strategies may differentially target vulnerability for relapse.

Methods
The smartphone application ‘Imagine your mood’ has been developed specifically for this study to assess emotions, imagery, cognitions, and behaviors in daily life. Parallel to the randomized controlled trial ‘Disrupting the rhythm of depression’, 45 remitted recurrently depressed individuals taking continuation antidepressant medication will be randomly assigned to either continuing antidepressant medication (n = 15), continuing antidepressant medication combined with an eight-session preventive cognitive therapy (n = 15), or tapering of antidepressant medication in combination with preventive cognitive therapy (n = 15). Relapse and return of depressive symptomatology over a 24-month follow-up will be assessed. Additionally, matched never depressed individuals (n = 15) will be recruited as controls.

Discussion
This innovative study combines the strengths of a randomized controlled trial and experience sampling methodology in a micro-trial to explore individual differences in risk of relapse and what works for whom to prevent relapse. Results may ultimately pave the way for therapists to tailor relapse prevention strategies to individual (affective) vulnerability.

Original language	English
Pages (from-to)	172-178
Number of pages	7
Journal	Contemporary Clinical Trials Communications
Volume	7
DOIs	https://doi.org/10.1016/j.conctc.2017.07.003
Publication status	Published - Sept-2017

Keywords

Recurrent MDD
Relapse prevention
Psychological interventions
Antidepressant medication
Experience sampling methodology
RELAPSE/RECURRENCE
POPULATION
CRITICAL SLOWING-DOWN
COGNITIVE THERAPY
ANTIDEPRESSANT MEDICATION
MAJOR DEPRESSION
CLINICAL-COURSE
DISORDER
METAANALYSIS
PREVALENCE

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Slofstra, C., Klein, N. S., Nauta, M. H., Wichers, M., Batalas, N., & Bockting, C. L. H. (2017). Imagine your mood: Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression. Contemporary Clinical Trials Communications, 7, 172-178. https://doi.org/10.1016/j.conctc.2017.07.003

Slofstra, Christien ; Klein, Nicola S. ; Nauta, Maaike H. et al. / Imagine your mood : Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression. In: Contemporary Clinical Trials Communications. 2017 ; Vol. 7. pp. 172-178.

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title = "Imagine your mood: Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression",

abstract = "BackgroundRelapse prevention strategies include continuation of antidepressant medication and preventive psychological interventions. This study aims to gain understanding that may inform tailoring of relapse prevention to individual differences, to improve their effects. Such treatment personalization may be based on repeated assessments within one individual, using experience sampling methodology. As a first step towards informing decisions based on this methodology, insight is needed in individual differences in risk of relapse and response to treatment, and how relapse prevention strategies may differentially target vulnerability for relapse.MethodsThe smartphone application {\textquoteleft}Imagine your mood{\textquoteright} has been developed specifically for this study to assess emotions, imagery, cognitions, and behaviors in daily life. Parallel to the randomized controlled trial {\textquoteleft}Disrupting the rhythm of depression{\textquoteright}, 45 remitted recurrently depressed individuals taking continuation antidepressant medication will be randomly assigned to either continuing antidepressant medication (n = 15), continuing antidepressant medication combined with an eight-session preventive cognitive therapy (n = 15), or tapering of antidepressant medication in combination with preventive cognitive therapy (n = 15). Relapse and return of depressive symptomatology over a 24-month follow-up will be assessed. Additionally, matched never depressed individuals (n = 15) will be recruited as controls.DiscussionThis innovative study combines the strengths of a randomized controlled trial and experience sampling methodology in a micro-trial to explore individual differences in risk of relapse and what works for whom to prevent relapse. Results may ultimately pave the way for therapists to tailor relapse prevention strategies to individual (affective) vulnerability.",

keywords = "Recurrent MDD, Relapse prevention, Psychological interventions, Antidepressant medication, Experience sampling methodology, RELAPSE/RECURRENCE , POPULATION, CRITICAL SLOWING-DOWN, COGNITIVE THERAPY, ANTIDEPRESSANT MEDICATION, MAJOR DEPRESSION, CLINICAL-COURSE, DISORDER, METAANALYSIS, PREVALENCE",

author = "Christien Slofstra and Klein, {Nicola S.} and Nauta, {Maaike H.} and Marieke Wichers and Nikolaos Batalas and Bockting, {Claudi L.H.}",

year = "2017",

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doi = "10.1016/j.conctc.2017.07.003",

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Slofstra, C, Klein, NS, Nauta, MH , Wichers, M, Batalas, N & Bockting, CLH 2017, 'Imagine your mood: Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression', Contemporary Clinical Trials Communications, vol. 7, pp. 172-178. https://doi.org/10.1016/j.conctc.2017.07.003

Imagine your mood: Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression. / Slofstra, Christien; Klein, Nicola S.; Nauta, Maaike H. et al.
In: Contemporary Clinical Trials Communications, Vol. 7, 09.2017, p. 172-178.

Research output: Contribution to journal › Article › Academic › peer-review

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T2 - Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression

AU - Slofstra, Christien

AU - Klein, Nicola S.

AU - Nauta, Maaike H.

AU - Wichers, Marieke

AU - Batalas, Nikolaos

AU - Bockting, Claudi L.H.

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N2 - BackgroundRelapse prevention strategies include continuation of antidepressant medication and preventive psychological interventions. This study aims to gain understanding that may inform tailoring of relapse prevention to individual differences, to improve their effects. Such treatment personalization may be based on repeated assessments within one individual, using experience sampling methodology. As a first step towards informing decisions based on this methodology, insight is needed in individual differences in risk of relapse and response to treatment, and how relapse prevention strategies may differentially target vulnerability for relapse.MethodsThe smartphone application ‘Imagine your mood’ has been developed specifically for this study to assess emotions, imagery, cognitions, and behaviors in daily life. Parallel to the randomized controlled trial ‘Disrupting the rhythm of depression’, 45 remitted recurrently depressed individuals taking continuation antidepressant medication will be randomly assigned to either continuing antidepressant medication (n = 15), continuing antidepressant medication combined with an eight-session preventive cognitive therapy (n = 15), or tapering of antidepressant medication in combination with preventive cognitive therapy (n = 15). Relapse and return of depressive symptomatology over a 24-month follow-up will be assessed. Additionally, matched never depressed individuals (n = 15) will be recruited as controls.DiscussionThis innovative study combines the strengths of a randomized controlled trial and experience sampling methodology in a micro-trial to explore individual differences in risk of relapse and what works for whom to prevent relapse. Results may ultimately pave the way for therapists to tailor relapse prevention strategies to individual (affective) vulnerability.

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KW - DISORDER

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KW - PREVALENCE

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JO - Contemporary Clinical Trials Communications

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Slofstra C, Klein NS, Nauta MH , Wichers M, Batalas N, Bockting CLH. Imagine your mood: Study design and protocol of a randomized controlled micro-trial using app-based experience sampling methodology to explore processes of change during relapse prevention interventions for recurrent depression. Contemporary Clinical Trials Communications. 2017 Sept;7:172-178. doi: 10.1016/j.conctc.2017.07.003