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Supplementary Table 1. RO DBT Skills Group Lesson PlanWEEKSourceMINDFULNESS (2 WEEKS)1Mindfulness Handouts 1A, 1B, 1C, 1D, 1ERO DBT Skills (Lynch)2Mindfulness Handouts 2, 3Standard DBT Skills (Linehan)EMOTION REGULATION (6 WEEKS)3Emotion Regulation Handout 1, 2, 3, and Homework Sheet 1Standard DBT Skills (Linehan)4Emotion Regulation Handout 4, 5, and Homework Sheet 25Emotion Regulation Handout 6, 7, 8, and Homework Sheet 36Emotion Regulation Handout 9, and Homework Sheet 37Emotion Regulation Handout 10, and Homework Sheet 38Envy, Resentment, Revenge, Bitterness Worksheets 1A and 1B RO DBT Skills (Lynch)MINDFULNESS (2 WEEKS)9Mindfulness Handouts 1A, 1B, 1C, 1D, 1ERO DBT Skills (Lynch)10Mindfulness Handouts 2, 3Standard DBT Skills (Linehan)RADICAL OPENNESS (8 WEEKS)11Radical Openness Handouts 1A, 1B, 1C, 1D, 1ERO DBT Skills (Lynch)12Radical Openness Handouts 2A, 2B, 2C13Radical Openness Worksheet 3A, 3B, 3C14Radical Openness Handout 4A, 4B, 4C15Radical Openness Handout 5A, 5B16Radical Openness Handout 6A, 6B, 6C, 6D, 6E17Radical Openness Handout 7A, 7B18Radical Openness Handout 8A, 8BDISTRESS TOLERANCE (1 WEEK)19Distress Tolerance Handout 1 (ONLY page 167 “Self-Soothe”), and 2, 3, 4, 5 (Only page 177)Standard DBT Skills (Linehan)MINDFULNESS (2 WEEKS)20Mindfulness Handouts 1A, 1B, 1C, 1D, 1ERO DBT Skills (Lynch)21Mindfulness Handouts 2, 3Standard DBT Skills (Linehan)INTERPERSONAL EFFECTIVENESS (6 WEEKS)22Interpersonal Effectiveness Handout 1, 2 and Homework Sheet 1Standard Skills Manual (Linehan)23Interpersonal Effectiveness Handout 3, 4, and Homework Sheet 224Interpersonal Effectiveness Handout 5, 6, 25Interpersonal Effectiveness Handout 7, 8, and Homework Sheet 326Interpersonal Effectiveness Handout 927Interpersonal Effectiveness Handout 10Supplementary Table 2 HRSD and secondary outcomes by group at 0, 7, 12 and 18 months (this is a more detailed version of Table 1 in the main text)Dep. Var.Mean or SDMonthRO DBTTAUDifferenceLower CBUpper CBPEvidence ratio (d?>?0)AAQAdjusted means and contrasts0 38.5338.530.00?7.877.871.0000.777 33.1236.48?3.37?7.951.210.09630.4712 32.5637.50?4.94?9.44?0.450.040121.8218 30.6936.17?5.48?9.44?1.520.01455.98Raw means (n?=?162 v 88)038.2339.10(n?=?121 v 62)732.8637.05(n?=?130 v 60)1232.0337.11(n?=?115 v 55)1831.5836.11Standard 07.186.33deviations79.757.661210.278.411810.608.88EACAdjusted means0 16.1016.100.00?3.833.831.0001.00and contrasts7 18.3816.891.50?0.843.830.13236.3612 18.6415.103.551.225.870.0173242.2418 19.3116.332.980.845.120.012278.72Raw means015.9016.47718.6616.921218.6415.221818.9816.63Standard deviations04.684.6075.075.41125.345.78185.314.74HRSDAdjusted means0 23.1423.14?0.05?4.444.340.9791.10and contrasts7 15.3420.73?5.40?9.84?0.950.02346.3012 14.1916.34?2.15?6.582.270.2905.5318 13.7915.48?1.69?6.222.840.4244.67Raw means022.9623.48715.9719.741214.7016.051814.1315.67Standard 05.275.20deviations78.807.22128.866.71188.347.32MSSIAdjusted means0 7.72 7.72?0.00?2.922.921.0000.95and contrasts7 4.66 6.50?1.84?4.490.800.15017.5812 2.46 3.90?1.44?4.031.150.2295.1418 2.04 1.600.45?2.483.370.7531.52Raw means08.067.0974.785.25122.552.30182.672.45Standard 011.009.59deviations79.129.89126.266.11187.318.39PHQ9Adjusted means0 19.2419.24?0.00?5.025.021.0000.86and contrasts7 13.2416.69?3.45?6.61?0.290.04130.8212 13.0415.96?2.92?6.040.200.05833.6418 12.8716.10?3.23?6.05?0.400.03012.39Raw means018.9919.69713.4216.561212.6616.031813.4515.22Standard 05.144.78deviations77.476.84127.906.78188.077.08SSQAdjusted means00.15 0.150.01?0.440.460.9520.92and contrasts70.15?0.070.22?0.230.670.2790.15120.25?0.050.30?0.150.750.1570.1018 0.27?0.130.40?0.080.870.0930.20Raw means00.150.1570.050.06120.230.06180.180.10Standard 01.020.90deviations71.030.99120.911.07181.001.08Cols: Dep. Var., Dependent variable; SD, Standard deviation; RO DBT, Radically Open Dialectical Behaviour Therapy; TAU, Treatment as usualCB, Confidence bound; Evidence ratio (d?>?0), Evidence ratio for hypothesis that RO DBT is better than TAU.Rows: AAQ, Action and Acceptance Questionnaire; EAC, Emotional Approach Coping;HRSD, Hamilton Rating Scale for Depression; MSSI, Modified Scale for Suicide Ideation;PHQ-9, Patient Health Questionnaire-9; SSQ, Social Support Questionnaire.Supplementary Table 3 CONSORT 2010 checklist of information to include when reporting a randomised trialaSection/TopicItem NoChecklist itemReported statusTitle and abstract1aIdentification as a randomised trial in the titleYES1bStructured summary of trial design, methods, results, and conclusions (for specific guidance see CONSORT for abstracts)YESIntroductionBackground and objectives2aScientific background and explanation of rationaleYES2bSpecific objectives or hypothesesYESMethodsTrial design3aDescription of trial design (such as parallel, factorial) including allocation ratioYES3bImportant changes to methods after trial commencement (such as eligibility criteria), with reasonsYESParticipants4aEligibility criteria for participantsYES4bSettings and locations where the data were collectedYESInterventions5The interventions for each group with sufficient details to allow replication, including how and when they were actually administeredYESOutcomes6aCompletely defined pre-specified primary and secondary outcome measures, including how and when they were assessedYES6bAny changes to trial outcomes after the trial commenced, with reasonsNot applicableSample size7aHow sample size was determinedYES7bWhen applicable, explanation of any interim analyses and stopping guidelinesYESRandomisation:?Sequence generation8aMethod used to generate the random allocation sequenceYES8bType of randomisation; details of any restriction (such as blocking and block size)YES?Allocation concealment mechanism9Mechanism used to implement the random allocation sequence (such as sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assignedYES?Implementation10Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventionsYESBlinding11aIf done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and howYES11bIf relevant, description of the similarity of interventionsNot applicableStatistical methods12aStatistical methods used to compare groups for primary and secondary outcomesYES12bMethods for additional analyses, such as subgroup analyses and adjusted analysesYESResultsParticipant flow (a diagram is strongly recommended)13aFor each group, the numbers of participants who were randomly assigned, received intended treatment, and were analysed for the primary outcomeYES text and Fig. 113bFor each group, losses and exclusions after randomisation, together with reasonsYes text and Fig. 1Recruitment14aDates defining the periods of recruitment and follow-upYES14bWhy the trial ended or was stoppedNot applicableBaseline data15A table showing baseline demographic and clinical characteristics for each groupDescription in text YES – table can be added as supplemental material if requestedNumbers analysed16For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groupsYes, text and Fig. 1Outcomes and estimation17aFor each primary and secondary outcome, results for each group, and the estimated effect size and its precision (such as 95% confidence interval)Yes, text and Table 1, Figs 2 and 317bFor binary outcomes, presentation of both absolute and relative effect sizes is recommendedYESAncillary analyses18Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratoryNot applicableHarms19All important harms or unintended effects in each group (for specific guidance see CONSORT for harms)YESDiscussionLimitations20Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analysesYESGeneralisability21Generalisability (external validity, applicability) of the trial findingsYESInterpretation22Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidenceYESOther informationRegistration23Registration number and name of trial registryYESProtocol24Where the full trial protocol can be accessed, if availableReference 11Funding25Sources of funding and other support (such as supply of drugs), role of fundersYESaWe strongly recommend reading this statement in conjunction with the CONSORT 2010 Explanation and Elaboration for important clarifications on all the items. If relevant, we also recommend reading CONSORT extensions for cluster randomised trials, non-inferiority and equivalence trials, non-pharmacological treatments, herbal interventions, and pragmatic trials. Additional extensions are forthcoming: for those and for up to date references relevant to this checklist, see consort-. ................
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