Augmenting neurocognitive remediation therapy to Preventive Cognitive Therapy for partially remitted depressed patients: protocol of a pragmatic multicentre randomised controlled trial
Introduction Major depressive disorder (MDD) affects 163 million people globally every year. Individuals who experience subsyndromal depressive symptoms during remission (ie, partial remission of MDD) are especially at risk for a return to a depressive episode within an average of 4 months. Simultan...
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BMJ Publishing Group
2022-06-01
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| Series: | BMJ Open |
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| author | Huibert Burger Claudi Bockting Marlies Brouwer Gert J Geurtsen Amanda M Legemaat Johanne G J van der Stappen Maria Semkovska Isidoor O Bergfeld Nicoline Lous Damiaan A J P Denys |
| author_facet | Huibert Burger Claudi Bockting Marlies Brouwer Gert J Geurtsen Amanda M Legemaat Johanne G J van der Stappen Maria Semkovska Isidoor O Bergfeld Nicoline Lous Damiaan A J P Denys |
| author_sort | Huibert Burger |
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| description | Introduction Major depressive disorder (MDD) affects 163 million people globally every year. Individuals who experience subsyndromal depressive symptoms during remission (ie, partial remission of MDD) are especially at risk for a return to a depressive episode within an average of 4 months. Simultaneously, partial remission of MDD is associated with work and (psycho)social impairment and a lower quality of life. Brief psychological interventions such as preventive cognitive therapy (PCT) can reduce depressive symptoms or relapse for patients in partial remission, although achieving full remission with treatment is still a clinical challenge. Treatment might be more effective if cognitive functioning of patients is targeted as well since cognitive problems are the most persisting symptom in partial remission and predict poor treatment response and worse functioning. Studies show that cognitive functioning of patients with (remitted) MDD can be improved by online neurocognitive remediation therapy (oNCRT). Augmenting oNCRT to PCT might improve treatment effects for these patients by strengthening their cognitive functioning alongside a psychological intervention.Methods and analysis This study will examine the effectiveness of augmenting oNCRT to PCT in a pragmatic national multicentre superiority randomised controlled trial. We will include 115 adults partially remitted from MDD with subsyndromal depressive symptoms defined as a Hamilton Depression Rating Scale score between 8 and 15. Participants will be randomly allocated to PCT with oNCRT, or PCT only. Primary outcome measure is the effect on depressive symptomatology over 1 year. Secondary outcomes include time to relapse, cognitive functioning, quality of life and healthcare costs. This first dual approach study of augmenting oNCRT to PCT might facilitate full remission in partially remitted individuals as well as prevent relapse over time.Ethics and dissemination Ethical approval was obtained by Academic Medical Center, Amsterdam. Outcomes will be made publicly available.Trial registration number NL9582. |
| format | Article |
| id | doaj-art-eb9453779bfd431b84e20dac728508b2 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-06-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-eb9453779bfd431b84e20dac728508b22025-01-24T17:20:15ZengBMJ Publishing GroupBMJ Open2044-60552022-06-0112610.1136/bmjopen-2022-063407Augmenting neurocognitive remediation therapy to Preventive Cognitive Therapy for partially remitted depressed patients: protocol of a pragmatic multicentre randomised controlled trialHuibert Burger0Claudi Bockting1Marlies Brouwer2Gert J Geurtsen3Amanda M Legemaat4Johanne G J van der Stappen5Maria Semkovska6Isidoor O Bergfeld7Nicoline Lous8Damiaan A J P Denys9Department of General Practice and Elderly Care Medicine, University of Groningen, University Medical Center Groningen, Groningen, The NetherlandsDepartment of Psychiatry, Amsterdam UMC, Location AMC, Amsterdam, The NetherlandsDepartment of Psychiatry, Amsterdam UMC, Location AMC, Amsterdam, The Netherlands4 Department of Medical Psychology, Amsterdam University Medical Centers, Amsterdam, The NetherlandsDepartment of Psychiatry, Amsterdam UMC, location University of Amsterdam, Amsterdam, The NetherlandsDepartment of Psychiatry, Amsterdam UMC, location University of Amsterdam, Amsterdam, The NetherlandsDepartment of Psychology, University of Southern Denmark, Odense, DenmarkDepartment of Psychiatry, Amsterdam UMC, location University of Amsterdam, Amsterdam, The NetherlandsDepressie Vereniging, Amersfoort, The Netherlands1 Psychiatry, Amsterdam UMC Locatie AMC, Amsterdam, The NetherlandsIntroduction Major depressive disorder (MDD) affects 163 million people globally every year. Individuals who experience subsyndromal depressive symptoms during remission (ie, partial remission of MDD) are especially at risk for a return to a depressive episode within an average of 4 months. Simultaneously, partial remission of MDD is associated with work and (psycho)social impairment and a lower quality of life. Brief psychological interventions such as preventive cognitive therapy (PCT) can reduce depressive symptoms or relapse for patients in partial remission, although achieving full remission with treatment is still a clinical challenge. Treatment might be more effective if cognitive functioning of patients is targeted as well since cognitive problems are the most persisting symptom in partial remission and predict poor treatment response and worse functioning. Studies show that cognitive functioning of patients with (remitted) MDD can be improved by online neurocognitive remediation therapy (oNCRT). Augmenting oNCRT to PCT might improve treatment effects for these patients by strengthening their cognitive functioning alongside a psychological intervention.Methods and analysis This study will examine the effectiveness of augmenting oNCRT to PCT in a pragmatic national multicentre superiority randomised controlled trial. We will include 115 adults partially remitted from MDD with subsyndromal depressive symptoms defined as a Hamilton Depression Rating Scale score between 8 and 15. Participants will be randomly allocated to PCT with oNCRT, or PCT only. Primary outcome measure is the effect on depressive symptomatology over 1 year. Secondary outcomes include time to relapse, cognitive functioning, quality of life and healthcare costs. This first dual approach study of augmenting oNCRT to PCT might facilitate full remission in partially remitted individuals as well as prevent relapse over time.Ethics and dissemination Ethical approval was obtained by Academic Medical Center, Amsterdam. Outcomes will be made publicly available.Trial registration number NL9582.https://bmjopen.bmj.com/content/12/6/e063407.full |
| spellingShingle | Huibert Burger Claudi Bockting Marlies Brouwer Gert J Geurtsen Amanda M Legemaat Johanne G J van der Stappen Maria Semkovska Isidoor O Bergfeld Nicoline Lous Damiaan A J P Denys Augmenting neurocognitive remediation therapy to Preventive Cognitive Therapy for partially remitted depressed patients: protocol of a pragmatic multicentre randomised controlled trial BMJ Open |
| title | Augmenting neurocognitive remediation therapy to Preventive Cognitive Therapy for partially remitted depressed patients: protocol of a pragmatic multicentre randomised controlled trial |
| title_full | Augmenting neurocognitive remediation therapy to Preventive Cognitive Therapy for partially remitted depressed patients: protocol of a pragmatic multicentre randomised controlled trial |
| title_fullStr | Augmenting neurocognitive remediation therapy to Preventive Cognitive Therapy for partially remitted depressed patients: protocol of a pragmatic multicentre randomised controlled trial |
| title_full_unstemmed | Augmenting neurocognitive remediation therapy to Preventive Cognitive Therapy for partially remitted depressed patients: protocol of a pragmatic multicentre randomised controlled trial |
| title_short | Augmenting neurocognitive remediation therapy to Preventive Cognitive Therapy for partially remitted depressed patients: protocol of a pragmatic multicentre randomised controlled trial |
| title_sort | augmenting neurocognitive remediation therapy to preventive cognitive therapy for partially remitted depressed patients protocol of a pragmatic multicentre randomised controlled trial |
| url | https://bmjopen.bmj.com/content/12/6/e063407.full |
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