Mechanisms of rumination change in adolescent depression (RuMeChange): study protocol for a randomised controlled trial of rumination-focused cognitive behavioural therapy to reduce ruminative habit and risk of depressive relapse in high-ruminating adolescents
dc.contributor.author | Roberts, H | |
dc.contributor.author | Jacobs, RH | |
dc.contributor.author | Bessette, KL | |
dc.contributor.author | Crowell, SE | |
dc.contributor.author | Westlund-Schreiner, M | |
dc.contributor.author | Thomas, L | |
dc.contributor.author | Easter, RE | |
dc.contributor.author | Pocius, SL | |
dc.contributor.author | Dillahunt, A | |
dc.contributor.author | Frandsen, S | |
dc.contributor.author | Schubert, B | |
dc.contributor.author | Farstead, B | |
dc.contributor.author | Kerig, P | |
dc.contributor.author | Welsh, RC | |
dc.contributor.author | Jago, D | |
dc.contributor.author | Langenecker, SA | |
dc.contributor.author | Watkins, ER | |
dc.date.accessioned | 2022-07-04T08:48:03Z | |
dc.date.issued | 2021-04-23 | |
dc.date.updated | 2022-07-04T08:13:34Z | |
dc.description.abstract | BACKGROUND: Adolescent-onset depression often results in a chronic and recurrent course, and is associated with worse outcomes relative to adult-onset depression. Targeting habitual depressive rumination, a specific known risk factor for relapse, may improve clinical outcomes for adolescents who have experienced a depressive episode. Randomized controlled trials (RCTs) thus far have demonstrated that rumination-focused cognitive behavioral therapy (RFCBT) reduces depressive symptoms and relapse rates in patients with residual depression and adolescents and young adults with elevated rumination. This was also observed in a pilot RCT of adolescents at risk for depressive relapse. Rumination can be measured at the self-report, behavioral, and neural levels- using patterns of connectivity between the Default Mode Network (DMN) and Cognitive Control Network (CCN). Disrupted connectivity is a putative important mechanism for understanding reduced rumination via RFCBT. A feasibility trial in adolescents found that reductions in connectivity between DMN and CCN regions following RFCBT were correlated with change in rumination and depressive symptoms. METHOD: This is a phase III two-arm, two-stage, RCT of depression prevention. The trial tests whether RFCBT reduces identified risk factors for depressive relapse (rumination, patterns of neural connectivity, and depressive symptoms) in adolescents with partially or fully remitted depression and elevated rumination. In the first stage, RFCBT is compared to treatment as usual within the community. In the second stage, the comparator condition is relaxation therapy. Primary outcomes will be (a) reductions in depressive rumination, assessed using the Rumination Response Scale, and (b) reductions in resting state functional magnetic resonance imaging connectivity of DMN (posterior cingulate cortex) to CCN (inferior frontal gyrus), at 16 weeks post-randomization. Secondary outcomes include change in symptoms of depression following treatment, recurrence of depression over 12 months post-intervention period, and whether engagement with therapy homework (as a dose measure) is related to changes in the primary outcomes. DISCUSSION: RFCBT will be evaluated as a putative preventive therapy to reduce the risk of depressive relapse in adolescents, and influence the identified self-report, behavioral, and neural mechanisms of change. Understanding mechanisms that underlie change in rumination is necessary to improve and further disseminate preventive interventions. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03859297 , registered 01 March 2019. | en_GB |
dc.description.sponsorship | National Institute of Mental Health (NIMH) | en_GB |
dc.format.extent | 206- | |
dc.format.medium | Electronic | |
dc.identifier.citation | Vol. 21, article 206 | en_GB |
dc.identifier.doi | https://doi.org/10.1186/s12888-021-03193-3 | |
dc.identifier.grantnumber | MH118060 | en_GB |
dc.identifier.uri | http://hdl.handle.net/10871/130145 | |
dc.identifier | ORCID: 0000-0002-2432-5577 (Watkins, Edward R) | |
dc.language.iso | en | en_GB |
dc.publisher | BMC | en_GB |
dc.relation.url | https://www.ncbi.nlm.nih.gov/pubmed/33892684 | en_GB |
dc.rights | © 2021 The Author(s). Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data. | en_GB |
dc.subject | Adolescence | en_GB |
dc.subject | Cognitive behavioral therapy | en_GB |
dc.subject | Depression | en_GB |
dc.subject | Development | en_GB |
dc.subject | Resting state networks | en_GB |
dc.subject | Rumination | en_GB |
dc.title | Mechanisms of rumination change in adolescent depression (RuMeChange): study protocol for a randomised controlled trial of rumination-focused cognitive behavioural therapy to reduce ruminative habit and risk of depressive relapse in high-ruminating adolescents | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2022-07-04T08:48:03Z | |
dc.identifier.issn | 1471-244X | |
exeter.article-number | 206 | |
exeter.place-of-publication | England | |
dc.description | This is the final version. Available on open access from BMC via the DOI in this record | en_GB |
dc.description | Availability of data and materials: The study is registered on clinicaltrials.gov (NCT03859297), which will be updated with the published protocol and the study results and associated publications. De-identified data and results will be submitted to the National Database for Clinical Trials Related to Mental Illness (NDCT). NDCT provides a secure system to support the submission, sharing and access of relevant data at all levels of biological and behavioral organization and for all data types. Access to data for research purposes will be provided through the Data Access Committee. In accordance with the trial resource sharing agreement, data will additionally be deposited into the National Database for Autism Research, which is a US national database that houses deidentified data from many federal studies, irrespective of the disease/disorder/condition under study. | en_GB |
dc.identifier.eissn | 1471-244X | |
dc.identifier.journal | BMC Psychiatry | en_GB |
dc.relation.ispartof | BMC Psychiatry, 21(1) | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | en_GB |
dcterms.dateAccepted | 2021-04-01 | |
dc.rights.license | CC BY | |
rioxxterms.version | VoR | en_GB |
rioxxterms.licenseref.startdate | 2021-04-23 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2022-07-04T08:45:56Z | |
refterms.versionFCD | VoR | |
refterms.dateFOA | 2022-07-04T08:48:10Z | |
refterms.panel | A | en_GB |
refterms.dateFirstOnline | 2021-04-23 |
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Except where otherwise noted, this item's licence is described as © 2021 The Author(s). Open Access. This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated in a credit line to the data.