TY - JOUR
T1 - Imagine your mood
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, C.
AU - Klein, N.S.
AU - Nauta, M.H.
AU - Wichers, M.
AU - Batalas, N.
AU - Bockting, C.L.H.
PY - 2017/9/1
Y1 - 2017/9/1
N2 - 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. Trial registration ISRCTN15472145, retrospectively registered.
AB - 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. Trial registration ISRCTN15472145, retrospectively registered.
KW - Antidepressant medication
KW - Experience sampling methodology
KW - Psychological interventions
KW - Recurrent MDD
KW - Relapse prevention
UR - http://www.scopus.com/inward/record.url?scp=85024405231&partnerID=8YFLogxK
U2 - 10.1016/j.conctc.2017.07.003
DO - 10.1016/j.conctc.2017.07.003
M3 - Article
C2 - 29696182
AN - SCOPUS:85024405231
SN - 2451-8654
VL - 7
SP - 172
EP - 178
JO - Contemporary Clinical Trials Communications
JF - Contemporary Clinical Trials Communications
ER -