The Effectiveness of Dialectical Behavior Therapy Compared to Schema Therapy for Borderline Personality Disorder: A Randomized Clinical Trial

Psycho he apy and Psychosoma ics S anda d Resea ch A icle Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 Recei ed: July 27, 2023 Accep ed: Ma ch 9, 2024 Published online: July 10, 2024 The E ec i eness o Dialec ical Beha io The apy Compa ed o Schema The apy o Bo de line Pe sonali y Diso de : A Randomized Clinical T ial Nele Assmann a, b Anja Schaich a, b A noud A n z c Till Wagne a Philipp He zog a, d, e Daniel Al a ez-Fische a, Vale ija Sipos a Kamila Jauch-Cha a a, b Jan Philipp Klein a Michael Hüppe g Ul ich Schweige a E a Fassbinde a, b a Depa men o Psychia y, Psychosoma ics and Psycho he apy, Uni e si y o Lübeck, Lübeck, Ge many; b Depa men o Psychia y and Psycho he apy, Ch is ian-Alb ech s-Uni e si ä zu Kiel, Kiel, Ge many; c Depa men o Clinical Psychology, Uni e si y o Ams e dam, Ams e dam, The Ne he lands; d Depa men o Psychology, Ha a d Uni e si y, Camb idge, MA, USA; e Depa men o Psychology, Uni e si y o Kaise slau e n–Landau, Landau, Ge many; Ins i u e o Neu ogene ics, Uni e si y o Lübeck, Lübeck, Ge many; g Depa men o Anaes hesiology, Uni e si y o Lübeck, Lübeck, Ge many Keywo ds Bo de line pe sonali y diso de ·Randomized clinical ials · E ec i eness ·Psycho he apy esea ch ·T ea men ou come Abs ac In oduc ion: In he ea men o bo de line pe sonali y diso de (BPD), he e is empi ical suppo o bo h dialec ical beha io he apy (DBT) and schema he apy (ST); hese ea men s ha e ne e been compa ed di ec ly. This s udy examines whe he ei he o hem is mo e e ec i e han he o he in ea ing pa ien s wi h BPD. Me hods: In his an- domized, pa allel-g oup, a e -blind clinical ial, ou pa ien s aged be ween 18 and 65 yea s wi h a p ima y diagnosis o BPD we e ec ui ed in a e ia y ou pa ien ea men cen e (Lübeck, Ge many). Pa icipan s we e andomized o DBT o ST wi h one indi idual and one g oup session pe week o e 1.5 yea s. The p ima y ou come was he BPD symp om se e i y assessed wi h he mean sco e o he Bo de line Pe sonali y Diso de Se e i y Index a 1-yea na u alis ic ollow-up. Resul s: Be ween No embe 26, 2014, and De- cembe 14, 2018, we en olled 164 pa ien s (mean age = 33.7 [SD = 10.61] yea s). O hese, 81 (49.4%) we e ea ed wi h ST and 83 (50.6%) wi h DBT, o e all, 130 (79.3%) we e emale. In en ion- o- ea analysis wi h gene alized linea mixed models did no show a significan di e ence a 1-yea na u alis ic ollow-up be ween DBT and ST o he BPDSI o al sco e (mean di e ence 3.32 [95% CI: –0.58–7.22], p= 0.094, d=−24 [–0.69; 0.20]) wi h lowe sco es o DBT. P e- o- ollow-up e ec sizes we e la ge in bo h g oups (DBT: d= 2.45 [1.88–3.02], ST: d= 1.78 [1.26–2.29]). Conclusion: Pa- ien s in bo h ea men g oups showed subs an ial im- p o emen s indica ing ha e en se e ely a ec ed pa ien s wi h BPD and a ious como bid diso de s can be ea ed success ully wi h DBT and ST. An addi ional non-in e io i y ial is needed o show i bo h ea men s a e equally Nele Assmann and Anja Schaich sha e fi s au ho ship. [email p o ec ed] www.ka ge .com/pps © 2024 The Au ho (s). Published by S. Ka ge AG, Basel Co espondence o: Nele Assmann, nele.assmann @ uksh.de This a icle is licensed unde he C ea i e Commons A ibu ion- NonComme cial4.0In e na ionalLicense (CCBY-NC)(h p://www. ka ge .com/Se ices/OpenAccessLicense).Usage and dis ibu ion o comme cial pu poses equi es w i en pe mission. E a um Augus 30, 2024. DOI: 10.1159/000540975 Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024 e ec i e. The ial was e ospec i ely egis e ed on he Ge man Clinical T ials Regis e , DRKS00011534 wi hou p o ocol changes. © 2024 The Au ho (s). Published by S. Ka ge AG, Basel In oduc ion Se e al psycho he apy me hods a e a ailable o ea ing bo de line pe sonali y diso de (BPD) wi h good empi ical e idence [1–3], and in e na ional guidelines highly ecommend diso de -specificpsy- cho he apy o pa ien s su e ing om BPD [4–6]. Two o he mos es ablished ea men s include dialec ical beha io he apy (DBT) [7, 8] and schema he apy (ST) [9, 10]. DBT is he mos equen ly s udied ea men o BPD, and i s e ec i eness has been demons a ed in se e al andomized con olled ials (RCTs) [2, 3]. E en hough ST is less o en s udied so a , he e a e p om- ising esul s om wo la ge [11, 12] and one small andomized ial [13] as well as s udies in ou ine ca e [14–16]. DBT and ST ha e ne e been compa ed in a an- domized ial so a . O e all, he e is a need o com- pa a i e clinical ials. Compa ing he e ec i eness o BPD ea men s may imp o e pa ien s’in o med choices and guide decision-making abou which ea men s o p io i ize in heal h ca e sys ems [17]. The p og ams o BPD (PRO*BPD) s udy is he fi s andomized ial o compa e he e ec i eness o ST and DBT in pa ien s wi h BPD [18]. I was implemen ed in o a ou ine e ia y ca e se ing o an ou pa ien clinic a fil- ia ed wi h inpa ien se ices. This ou pa ien se ice was explici ly se up o ea se e ely a ec ed pa ien s wi h BPD who a e epea edly seen in eme gency ooms o would o he wise be ea ed in inpa ien se ings. Resea ch in his popula ion is undamen al conside ing ha BPD is associa ed wi h high socie al cos s [19–22], p ima ily caused by inpa ien ea men . The p ima y hypo hesis was ha BPD associa ed symp oms di e be ween DBT and ST a he 1-yea na u alis ic ollow-up. Since in o ma ion om li e a- u e does no allow p edic ions on he di ec ionali y o he di e ence, a wo-sided hypo hesis was chosen. Seconda y ou comes included ea men e en ion, gene al symp om se e i y, dep ession, dissocia ion, quali y o li e, psy- chosocial unc ioning, and pa icipa ion. In addi ion, based on o me esea ch and heo e ical conside a ions ega ding DBT and ST, seconda y hypo heses we e o mula ed ega ding di e en ial e ec s in he seconda y ou comes: We hypo hesized ha DBT educes suicidali y, sel -ha m, and dissocia ion be e and as e han ST. A he same ime, ST would be be e in imp o ing he quali y o li e and educing gene al symp om se e i y and dep essi e symp oma ology (see s udy p o ocol o a de ailed explana ion [18]). Ma e ials and Me hods S udy Design The PRO*BPD s udy design is a single-cen e andomized clinical ial. The ec ui men o pa icipan s ook place in a e ia y ou pa ien ea men cen e o a uni e si y clinic a filia ed wi h inpa ien ea men in Lübeck, Ge many, mainly ea ing se e ely a ec ed pa ien s who canno ecei e ea men elsewhe e o canno su ficien ly be ea ed by p ac i ione s in p i a e p ac ices. The PRO*BPD s udy was designed in adhe ence o he Consolida ed S anda ds o Repo ing T ials (CONSORT) guide- lines and me hodology [23] and ollows me hodological ecom- menda ions o ials o psychological in e en ions [24] (sum- ma ized in online suppl. Table S1; o all online suppl. ma e ial, see h ps://doi.o g/10.1159/000538404). The planned sample size was N= 160 based on a powe analysis (powe 80%; medium e ec size, α= 0.05, n= 128) and aking a i ion (20%, n= 32) in o accoun [25]. De ails abou he s udy design a e published in he s udy p o ocol [18]. Pa icipan s Pa ien s we e eligible when hey (1) we e be ween 18 and 65 yea s o age, (2) had a p ima y diagnosis o BPD (diagnosed wi h he S uc u al Clinical In e iew o DSM-IV o Axis II; SCID-II-In e iew) [26], (3) had a BPD se e i y sco e >20 poin s on he Bo de line Pe sonali y Diso de Se e i y Index (BPDSI), Ve sion 4 [27], (4) ga e in o med consen , and (5) we e able and willing o pa icipa e eliably in he apy and assessmen p o- cedu es. Exclusion c i e ia we e (1) a li e ime diagnosis o a psycho ic diso de , (2) in ellec ual defici s (IQ <85), (3) poo Ge man language skills, and (4) acu e subs ance use diso de ha equi ed de oxifica ion ea men . Pa icipa ion was pos- sible a e comple ing de oxifica ion ea men and 4 weeks o abs inence. Pa icipan s wi h cannabis dependence could pa - icipa e i hey commi ed o wo king on abs inence du ing ea men . Randomiza ion and Masking Randomiza ion was conduc ed by P o . Michael Hüppe, who was no in ol ed in he da a collec ion and he apy using he p og am BiaS (11.02) [28]. A e comple ing he baseline assess- men , pa icipan s we e andomized o he wo condi ions (ST o DBT). Randomiza ion was s a ified by sex o a oid biases due o unbalanced sex dis ibu ion. The alloca ion sequence was con- cealed om bo h pa icipan s and esea che s. Ra e s we e blind o he assignmen ; pa icipan s we e in o med abou hei condi ion du ing he fi s he apy session. P ocedu e Pa icipan s comple ed assessmen s a baseline, 0.5 yea s a e he s a o ea men , one yea a e he s a o ea men , pos ea men (1.5 yea s), and wo na u alis ic ollow-up 250 Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 Assmann e al. Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024 assessmen s (0.5 yea s and one yea ). In he ollowing, he 1-yea ollow-up assessmen will be e e ed o as ollow-up (p ima y ou come). Assessmen s included sel - epo measu es and in e - iews (conduc ed by blind and independen a e s ained in he in e iews). Due o a wide ange o measu es, he baseline as- sessmen consis ed o h ee o ou appoin men s wi h he pa ien s and was scheduled wi hin 3 mon hs be o e he s a o ea men . In case, he e we e mo e han 3 mon hs be ween assessmen o he p ima y ou come and s a o ea men (due o a ailabili y o ea men slo s and missed appoin men s), he in e iew o he p ima y ou come was epea ed. Ou comes The p ima y ou come was he se e i y o BPD assessed by he o al sco e o he BPDSI-IV a 1-yea na u alis ic ollow-up. The BPDSI is a semi-s uc u ed in e iew including 70 i ems a ing he equency and se e i y o he nine BPD ai s desc ibed in he DSM-IV o e he p io 3 mon hs. The BPDSI is a eliable in- s umen wi h good psychome ic quali ies [29, 30]. In he p esen s udy, he assessed in e a e eliabili y was excellen (all in a-class co ela ion coe ficien s >0.997 [ICC], online suppl. ma e ial). In addi ion, suicidali y and he numbe o suicide a emp s we e iden ified using BPDSI da a. An inc ease o 11.70 o mo e in he BPDSI o al sco e compa ed o he baseline assessmen was defined as de e io a ion [11]. Seconda y ou come measu es included a sel - a ing ques ionnai e o he bu den expe ienced by BPD mani es- a ions (BPD checklis ) [31], he se e i y o dep ession (Quick In en o y o Dep essi e Symp oms, QIDS-SR) [32], global symp om se e i y (B ie Symp om In en o y, BSI) [33], dissocia ion (Dissocia ion Tension Scale, DSS) [34], psy- chosocial unc ioning and pa icipa ion (Wo ld Heal h O - ganiza ion Disabili y Assessmen Schedule 2.0, WHODAS 2.0 [35] and Wo k and Social Adjus men Scale, WSAS [36]) and quali y o li e (Wo ld Heal h O ganiza ion Quali y o Li e ques ionnai e, WHOQOL) [37]. Como bid men al diso de s we e assessed using he Ge man e sion o he SCID-I and II- In e iew [38, 39]. Fo u he in o ma ion on seconda y ou comes, see online supplemen a y ma e ial. Psychopha - macological ea men and demog aphic pa ame e s we e also assessed. T ea men e en ion was also analyzed as a sec- onda y ou come. To egis e also unwan ed ia ogenic e ec s o psycho he apy, we eco ded ad e se e en s (inpa ien ea men , suicide a emp s, cases o dea h) and analyzed de e io a ionin heBPDSI. T ea men Pa ien s we e andomized o DBT o ST; bo h included one indi idual session (60 min) and one g oup session (120 min) pe week and ollowed a w i en p o ocol [7, 8, 10, 40]. G oups consis ed o up o 10 BPD pa ien s and wo he apis s and we e o e ed in a semi-open o ma . The s a o he indi idual he apy was planned ou o 10 weeks be o e he beginning o g oup he apy. Eligible pa ien s who could no a end g oup sessions due o amily, p o essional, o educa ional du ies we e p o ided weekly indi idual he apy only. The ea men du- a ion was 1.5 yea s. Pa ien s coulds op he ea men p o- g am p ema u ely and we e conside ed as an “ea ly success”i hei BPDSI sco e was less han 15 and he he apis eam ag eed ha he pa ien should s op he p og am due o e- mission. Pa ien s could also be “pushed ou ”o he ea men p og am based on a decision o he he apis eam and he local supe iso [18]. We decided no o define explici ules o a pa ien o be “pushed ou ”o bo h condi ions. I should be no ed ha his is a di e ence om he s anda d DBT p o ocol [22]. In he PRO*BPD ial, a “push ou ”wasalwaysdecided by he he apis eam and he local supe iso s and was consis en wi h he espec i e ea men manual excep o he de ia ion men ioned abo e. A e he end o s udy ea men , no u he ea men was ecommended. As i was a na u- alis ic ollow-up, u he ea men was no p ohibi ed bu egis e ed a ollow-up assessmen s. I needed, pa ien s had he oppo uni y o see hei o me he apis mon hly o less equen ly. We had some de ia ions om ou o iginal p o ocol due o he COVID-19 pandemic and he e o e conduc ed a sensi i i y analysis excluding all pa icipan s a ec ed by he pandemic (online suppl. ma e ial). The apis s The apis s we e ad anced DBT and ST he apis s and he a- pis s who we e new o ST o DBT bu we e expe ienced in CBT, wi h aining be o e adminis e ing he ea men and lea ning he me hod unde close supe ision. Local and ex e nal ce ified specialis s ained he apis s o he specific me hod in se e al wo kshops. They pa icipa ed in weekly supe ision sessions unde he di ec ion o he locally app o ed supe iso s (DBT: VS, US, ST: EF) and eam mee ings. T ea men In eg i y All indi idual and g oup sessions we e ideo aped, and ad- he ence and compe ence we e a ed in a andom selec ion o session apes om di e en ea men s ages (each ea men s age 6 mon hs) by ained a e s. The ideos o he sessions we e a ed al oge he a e he end o he s udy ea men . Indi idual sessions we e a ed using an adap ed e sion (May 2014) o he The apy Adhe ence and Compe ence Scale o he apy o BPD by Young e al. [41] which was also used in Giesen-Bloo e al. [11] and he Dialec ical Beha io The apy Adhe ence Checklis –Indi idual The apy (DBT AC-I) obse e - a ed e sion [42]. The la e was chosen because a ings wi h he o iginally planned DBT adhe ence manual [43] we e only possible by DBT-specialis s ce ified o his and we e no co e ed by he unding o ou s udy. Adhe ence o ST g oup sessions was a ed using a scale combining he Schema The apis Compe ency Scale o indi idual he apy sessions (STCS-I-1) [44] and he G oup Schema The apy Ra ing Scale (GSTRS) and i s e ised e sion (GSTRS-R) [45]. Each i em o he scales was code 0/1 o adhe ence and 1–6 o compe ence. Fo he DBT g oup sessions, he e was no eely a ailable a ing scale. Ra ings o DBT g oup sessions would ha e been a ailable om ce ified a e s who did no pa icipa e in his s udy. Un o u- na ely, unding was no a ailable o hese a ings. Ten ideos o DBT g oup sessions we e a ed using he ST scale o ensu e disc imina ion. De ails on he a e aining can be ound in he online supplemen a y ma e ial. S a is ical Analysis O iginally, he hypo hesis ha he e is a di e ence be ween pa ien s ea ed wi h DBT and ST ega ding he educ ion o BPD symp oms was ope a ionalized as a di e ence be ween he slopes o e ime (baseline o 1-yea na u alis ic ollow-up) [18]. DBT e sus Schema The apy in Bo de line Pe sonali y Diso de Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 251 Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024 Due o unexpec ed baseline di e ences be ween DBT and ST (especially sel - a ed BPD symp oms and dep ession, see online suppl. Table S2), we had o adap ou analysis plan and had o con ol o he baseline sco es (see below and online suppl. ma e ial). Mo eo e , con olling o baseline sco es is ecom- mended independen ly om baseline di e ences [46]. As a consequence, we had o change he ope a ionaliza ion o he p ima y hypo hesis and es ed he di e ence a 1-yea na u- alis ic ollow-up. The s a is ical analyses we e pe o med wi h SPSS, e sion 28. Da a analyses ollowed he in en ion- o- ea (ITT) p inciple and used all a ailable da a. Pa ien s we e included in he ITT sample i hey we e andomized and a ended a leas one indi idual session whe e hey we e in o med abou ea men condi ion. Missing alues we e no impu ed as gene alized linea mixed models (GLMMs) can alidly es ima e e ec s unde he same assump ions as mul iple impu a ion. A s ep-by-s ep epo o he s a is ical analyses can be ound in he online supplemen a y ma e ial. Gi en skewed dis ibu ions, con inuous ou come a iables we e analyzed wi h GLMM gamma eg ession. As gamma eg ession canno handle ze os, a small alue (0.01) was added o all sco es, i ze os exis ed. Whe e es- ima ion allowed, we included a andom e ec o he ea men coho o accoun o he ac ha coho s o pa ien s pa icipa ed in g oup he apy oge he . Time was modeled acco ding o he bes model fi , e.g., linea , loga i hmic, o segmen ed de elopmen o sco es o e ime. We used a piece-wise eg ession model i he p ima y inspec ion o he da a indica ed ha change du ing ea men had a di e en slope han change du ing he na u alis ic ollow-up pe iod, and a compa ison o model fi confi med his imp ession. Fo piece-wise coded eg ession, we defined all as- sessmen s o he ea men phase as one sec ion and he ollow-up assessmen s sepa a ely. As p edefined in he s udy p o ocol, we included he use o psycho opic medica ion as a unning co a ia e coding he use o e e y assessmen poin . Since his can be discussed con o e sially, we conduc ed a sensi i i y analyses wi hou he medica ion co a ia e. The co a iance s uc u e o he epea ed pa and ime was modeled acco ding o he bes model fi . Addi ional co a ia es we e included as we obse ed sys ema ic baseline di e ences be ween ST and DBT in almos all ou come a iables wi h highe sco es o DBT pa ien s (online suppl. Table S2). We included a cen e ed baseline global se e i y sco e based on p incipal componen analysis, including all ou come a iables a baseline and he numbe o como bidi ies on axis I and II as well as he cen e ed baseline a iable as a co a ia e and excluded he baseline assessmen in he dependen ime a iable o all ou - comes [46]. The e o e, he main e ec o ea men a e 1-yea na u alis ic ollow-up was he p ima y es o ea men di e - ences. Thus, he fixed e ec s in he GLMM included ime, medica ion, ea men , and hei in e ac ion, as well as global se e i y, and he pa icula baseline sco e was also included in he fixed pa . A u he fixed e ec o ime piece-wise and i s in- e ac ion wi h ea men and medica ion we e included i a piece- wise eg ession model was used. The exac configu a ion o he GLMM o each ou come a iable is specified in online supple- men a y Table S3 and a defini ion o all a iables included in he model can be ound in online suppl. Table S4. Fo a de ailed s ep- by-s ep desc ip ion o he s a is ical analyses, e e o online supplemen a y ma e ial. The numbe o suicide a emp s du ing he las 3 mon hs was analyzed using gene alized es ima ing equa ions wi h a Tweedie dis ibu ion (because o many ze o coun s) wi h a log link and fi s -o de au o eg ession o he epea ed pa . T ea men e en ion was analyzed using GLMM su i al analysis. E ec sizes we e exp essed as o he fixed e ec s in he GLMM analyses and Cohen’sdas con en ional wi hin- and be ween-g oups e ec size. Fo a desc ip ion o e ec sizes, see online supplemen a y ma e ial. Addi ionally, we conduc ed a comple e analysis o he p ima y ou come, including all pa ien s ha comple ed ea men a e 1.5 yea s o le he p og am ea lie a e emission. Fu he , we conduc ed a sensi i i y analysis including only hose pa ien s who ecei ed he combina ion o g oup and indi idual he apy. We also conduc ed a sensi i i y analysis ollowing he o iginal analy ic plan including all assessmen poin s and no con olling o baseline di e ences. Las ly, we conduc ed a sensi i i y analysis excluding he medica ion co a ia e. Resul s Pa ien Flow and Sample Cha ac e is ics Be ween No embe 26, 2014, and Decembe 14, 2018, 255 pa ien s we e sc eened o eligibili y, and 164 we e included in he PRO*BPD ial’s ITT sample o he PRO*BPD ial. The las ollow-up assessmen was conduc ed on Janua y 20, 2022. The CONSORT flow diag am o pa icipan ec ui men is p esen ed in Figu e 1. Table 1 displays he demog aphic and clinical cha ac e is ics o he ITT sample. The mean numbe o sessions be o e he s a o g oup he apy was M= 4.3 (DBT and ST), and he a e age numbe o indi idual sessions was M= 44.48 (DBT) and M= 46.7 (ST) o he in en - o- ea sample and M= 52.4 (DBT) and M= 52.1 (ST) o he comple e sample. T ea men In eg i y O e all, 500 ideos ou o 7,475 indi idual sessions and 43 ideos ou o 436 g oup sessions we e a ed by ained a e s. The in e a e eliabili y was assessed o 20 a ings o indi idual sessions ( en ST and en DBT) and 19 a ings o g oup sessions ( en ST and nine DBT). In e a e eliabili y showed o be e y good bo h o he a ings o he indi idual sessions (ICC be ween 0.88 and 0.961) and o he ST a ings o he g oup sessions (ICCs be ween 0.991 and 0.992). The e was significan disc imina ion be ween ST and DBT a he ST, e- spec i ely, DBT adhe ence and compe ence scales (all p<0.009). ST g oup adhe ence and compe ence a ings also indica ed a good di e en ia ion be ween he condi ions (all p<0.001). 252 Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 Assmann e al. Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024 Mean adhe ence o he espec i e manuals was 93.33% in ST and 99.18% in DBT indi idual he apy. Mean he apeu ic compe ence was 5.27 o ST and 4.99 o DBT. Mean adhe ence in ST g oup he apy was 98.10%, and mean he apeu ic compe ence was 5.41. Fig. 1. CONSORT diag am o pa icipan flow. DBT e sus Schema The apy in Bo de line Pe sonali y Diso de Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 253 Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024 Table 1. Desc ip i e s a is ics a baseline T ea men condi ion all (N= 164) DBT (n= 83) ST (n= 81) Cha ac e is ic Age, yea s, M(SD) 33.71 (10.61) 34.54 (11.15) 32.85 (10.01) Gende , n(%) Male 33 (20.1) 17 (20.5) 16 (19.8) Female 130 (79.3) 66 (79.5) 64 (79.0) Non-bina y 1 (0.6) –1 (1.2) Rela ionship s a us, n(%) Pa ne 82 (50.0) 41 (49.4) 41 (50.6) No pa ne 82 (50.0) 42 (50.6) 40 (49.4) Educa ion le el, n(%) No/p ima y educa ion 9 (5.5) 5 (6.0) 4 (4.9) Lowe seconda y educa ion 92 (56.1) 46 (55.4) 46 (56.8) Uppe seconda y educa ion 49 (29.9) 26 (31.3) 23 (28.4) Te ia y educa ion 14 (8.5) 6 (7.2) 8 (9.9) E hnic backg ound, n(%) Ge man 151 (92.1) 78 (94.0) 74 (91.4) Di e en 12 (7.3) 5 (6.0) 7 (8.6) Wo k s a us, n(%) Wo king 20 (12.2) 7 (8.4) 13 (16.0) S udying 17 (10.4) 7 (8.4) 10 (12.3) Homemake 12 (7.3) 6 (7.2) 6 (7.4) Disabili y pension 41 (25.0) 22 (26.5) 19 (23.5) Unable o wo k due o sick lea e 44 (26.8) 25 (30.1) 19 (23.5) Unemployed 15 (9.1) 8 (9.6) 7 (8.6) Re i emen pension 3 (1.8) 3 (3.6) – O he 12 (7.3) 5 (6.0) 7 (8.6) BPD se e i y BPDSI a baseline, M(SD) 32.80 (8.71) 33.19 (9.38) 32.39 (8.01) Numbe o BPD c i e ia (SKID-II) 7.26 (1.26) 7.23 (1.32) 7.30 (1.21) Como bid Diso de s Numbe o como bid SCID-I diagnoses, M(SD) 3.99 (1.95) 4.12 (1.88) 3.85 (2.03) Numbe o como bid SCID-II diagnoses (excl. BPD), M(SD) 1.35 (1.12) 1.37 (1.06) 1.32 (1.18) Como bid pe sonali y diso de s, n(%) Pa anoid pe sonali y diso de 37 (22.6) 17 (20.5) 20 (24.7) Schizoid pe sonali y diso de 1 (0.6) –1 (1.2) Schizo ypal pe sonali y diso de 6 (3.7) 3 (3.6) 3 (3.7) An isocial pe sonali y diso de 3 (1.8) 1 (1.2) 2 (2.5) His ionic pe sonali y diso de 12 (7.3) 9 (10.8) 3 (3.7) Na cissis ic pe sonali y diso de 13 (7.9) 4 (4.8) 9 (11.1) A oidan pe sonali y diso de 69 (42.1) 39 (47.0) 30 (37.0) Dependen pe sonali y diso de 21 (12.8) 14 (16.9) 7 (8.6) Obsessi e-compulsi e pe sonali y diso de 59 (36.0) 27 (32.5) 32 (39.5) Como bid diso de s axis I, n(%) Any como bid axis I diagnosis 161 (98.2) 82 (98.8) 79 (97.5) A ec i e diso de s 108 (65.9) 59 (71.1) 49 (60.5) Anxie y diso de s 144 (87.8) 74 (89.2) 70 (86.4) Soma ic symp om diso de 21 (12.8) 11 (13.3) 10 (12.3) Subs ance use diso de 51 (31.1) 24 (28.9) 27 (33.3) Ea ing diso de s 76 (46.3) 41 (49.4) 35 (43.2) 254 Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 Assmann e al. Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024 Main Ou come The GLMM showed a significan educ ion o BPD se e i y measu ed by he BPDSI-IV o al sco e o e ime (0.5 yea s o 1-yea na u alis ic ollow-up) wi h la ge e ec sizes (p e-pos and p e- ollow-up) o bo h condi ions (Table 2; Fig. 2a). Howe e , ea men had no significan e ec a 1-yea na u alis ic ollow-up ( 131 =1.69,p=0.94, d=−0.24 [−0.69; 0.20]). See online supplemen a y Table S5 o he e ec s o GLMM co a ia es on all ou comes. The comple e and sensi i i y analyses did no show di e en esul s (see online suppl. ma e ial). Seconda y Ou comes BPDSI-Based Seconda y Ou comes All BPDSI subscales excep o (pa a)suicide showed asignifican educ ion o e ime (0.5 yea s o 1-yea na u alis ic ollow-up) (online suppl. Table S6). Fo his subscale, he wi hin-g oup p e- ollow-up e ec sizes we e also la ge in bo h condi ions indica ing a subs an ial imp o emen be ween baseline and 0.5 yea s which was no included in he GLMM. The wi hin-g oup p e- ollow-up e ec sizes o all o he subscales we e la ge; only in he subscale ange he e ec size in he ST condi ion was medium. This subscale was he only one wi h a significan ea men e ec a 1-yea na u alis ic ollow-up: pa ien s in he DBT condi ion had significan ly lowe sco es a his ime poin . The suicidali y sco e showed no significan e ec s, and he wi hin-g oup p e-pos e ec sizes we e medium in bo h condi ions (online suppl. Table S6). Fo he numbe o suicide a emp s in he las 3 mon hs, he e we e also no significan e ec s. The wi hin-g oup p e- ollow-up e ec sizes we e small o medium. O he Seconda y Ou comes All GLMM o seconda y ou comes showed a signifi- can ime e ec (0.5 yea s o 1-yea na u alis ic ollow- up), indica ing imp o emen , bu no e ec o ea men a 1-yea na u alis ic ollow-up (Table 2). The wi hin-g oup p e- ollow-up e ec sizes we e la ge o he BPD Checklis , BSI, QIDS-SR, WSAS, and WHODAS and small o la ge o he DSS (Table 2) and he WHOQOL subscales (online suppl. Table S7). T ea men Re en ion Figu e 2b shows ea men e en ion du ing he 1.5 yea s ea men pe iod. De ia ion con as s o he GLMM su i al analysis showed ha in he second qua e , significan ly mo e pa ien s d opped ou om DBT, 870 =−2.79, p= 0.005 (ST: 0% s. DBT: 7.2%), whe eas in he fi h qua e , significan ly mo e pa- ien s d opped ou om ST 870 =−2.21, p= 0.028 (ST: 4.9% s. DBT 0%). The o e all d opou a e was 22.9% o DBT and 23.5% o ST also including ew “push-ou s”(3.6% DBT; 1.2% ST). De ails on easons o d op ou can be ound in online supplemen a y Table S8. De e io a ion and Ad e se E en s De e io a ion was ound in <1% o all assessmen s (0.74% DBT, 0.76% ST). Fo an o e iew o ad e se e en s du ing he s udy pe iod, see online supplemen a y ma e ial. E ec s o Psycho opic Medica ion The p opo ion o pa ien s aking psycho opic medica ion is desc ip ed in online supplemen a y Table S9 sepa a ely o each assessmen poin and di e en medica ion ca ego ies. The main e ec s and in e ac ions in ol ing psycho opic medica ion in he GLMMs a e epo ed in online supplemen a y Table S5 and in- e p e ed in he online supplemen a y esul s. T ea men du ing he Na u alis ic Follow-Up Phase An o e iew o he ea men s ecei ed du ing he na u alis ic ollow-up pe iod can be ound in online supplemen a y Table S8. B iefly, 3.0% (0.5 yea s) and Table 1 (con inued) T ea men condi ion all (N= 164) DBT (n= 83) ST (n= 81) Psychia ic medica ion 1 ,n(%) 126 (76.8) 64 (77.1) 62 (76.5) P e ious ea men , n(%) 154 (93.9) 82 (98.8) 72 (88.9) P e ious psycho he apeu ic ea men , n(%) 151 (92.1) 80 (96.4) 71 (87.7) 1 Including medica ion i egula ly aken as needed. DBT e sus Schema The apy in Bo de line Pe sonali y Diso de Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 255 Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024 Table 2. Es ima ed means, 95% CIs, and e ec sizes o he p ima y and seconda y ou comes and e ec s ( ime, ime piece-wise, and ea men ) o he GLMM Es ima ed means (95% CI), e ec size Cohen’sdE ec s o he GLMM a DBT ST be ween-g oup e ec size d b [95% CI] Ou come and ime poin M[95% CI] wi hin-g oup e ec size d c [95% CI] M[95% CI] wi hin-g oup e ec size d c [95% CI] obse ed es ima ed d p BPDSI o al Baseline M= 32.80 e –Time −10.12 244 <0.001 0.54 0.5 yea s 25.20 [23.53; 26.99] 1.00 [0.54; 1.45] 27.76 [25.98; 29.66] 0.64 [0.19; 1.08] −0.24 [−0.58; 0.10] −0.27 [−0.61; 0.07] Time piece-wise 4.98 260 <0.001 0.29 1 yea 21.21 [19.64; 22.91] 1.70 [1.17; 2.17] 23.43 [21.71; 25.28] 1.29 [0.81; 1.77] −0.04 [−0.39; 0.31] −0.21 [−0.56; 0.14] T ea men a 1-yea FU 1.69 131 0.094 0.15 1.5 yea s (pos ) 17.85 [16.02; 19.89] 2.33 [1.77; 2.89] 19.77 [17.76; 22.01] 1.94 [1.41; 2.47] −0.01 [−0.40; 0.37] −0.17 [−0.56; 0.22] Time × T ea men 0.08 245 0.936 <0.01 0.5 yea s FU 17.58 [15.78; 19.59] 2.39 [1.83; 2.95] 20.20 [18.11; 22.53] 1.86 [1.34; 2.38] −0.17 [−0.59; 0.26] −0.19 [−0.61; 0.24] Time piece-wise × T ea men 0.49 260 0.628 0.03 1 yea FU 17.31 [15.03; 19.94] 2.45 [1.88; 3.02] 20.63 [17.79; 23.93] 1.78 [1.26; 2.29] −0.15 [−0.60; 0.30] −0.24 [−0.69; 0.20] BPD checklis d Baseline M= 84.67 e –Time −7.06 291 <0.001 0.38 0.5 yea s 61.92 [55.31; 69.33] 0.94 [0.49; 1.39] 72.08 [64.39; 80.70] 0.48 [0.04; 0.93] −0.03 [−0.39; 0.33] −0.32 [−0.68; 0.04] T ea men a 1-yea FU 1.65 86 0.102 0.18 1 yea 54.61 [49.14; 60.70] 1.32 [0.84; 1.79] 64.51 [57.90; 71.87] 0.82 [0.36; 1.27] −0.09 [−0.47; 0.28] −0.26 [−0.63; 0.12] Time × ea men 0.436 291 0.663 0.03 1.5 yea s (pos ) 48.17 [42.89; 54.10] 1.69 [1.19; 2.19] 57.73 [51.22; 65.08] 1.15 [0.68; 1.62] −0.02 [−0.46; 0.42] −0.20 [−0.64; 0.24] 0.5 yea s FU 42.48 [36.87; 48.95] 2.07 [1.54; 2.60] 51.67 [44.66; 59.78] 1.48 [0.99; 1.98] −0.19 [−0.66; 0.27] −0.25 [−0.72; 0.22] 1 yea FU 37.47 [31.40; 44.70] 2.45 [1.88; 3.02] 46.24 [38.60; 55.40] 1.82 [1.30; 2.33] −0.12 [−0.63; 0.38] −0.25 [−0.76; 0.25] DSS Baseline M= 2.90 e −Time −2.76 179 0.006 0.20 0.5 yea s 2.12 [1.73; 2.58] 0.45 [0.01; 0.89] 2.40 [1.99; 2.90] 0.27 [−0.17; 0.71] −0.07 [−0.43; 0.28] −0.15 [−0.50; 0.21] T ea men a 1-yea FU 1.31 246 0.193 0.08 1 yea 1.82 [1.54; 2.16] 0.67 [0.22; 1.11] 2.06 [1.74; 2.43] 0.49 [0.05; 0.93] 0.13 [−0.24; 0.50] −0.15 [−0.52; 0.23] Time × ea men 0.48 178 0.633 0.04 1.5 yea s (pos ) 1.57 [1.27; 1.93] 0.88 [0.43; 1.33] 1.76 [1.42; 2.18] 0.71 [0.26; 1.16] −0.03 [−0.47; 0.42] −0.11 [−0.56; 0.33] 0.5 yea s FU 1.57 [1.30; 1.89] 0.88 [0.43; 1.33] 1.90 [1.57; 2.30] 0.60 [0.16; 1.05] −0.09 [−0.57; 0.40] −0.20 [−0.68; 0.29] 1 yea FU 1.57 [1.23; 1.99] 0.88 [0.43; 1.33] 2.05 [1.57; 2.69] 0.49 [0.05; 0.94] 0.12 [−0.40; 0.63] −0.26 [−0.78; 0.26] 256 Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 Assmann e al. Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024 Table 2 (con inued) Es ima ed means (95% CI), e ec size Cohen’sdE ec s o he GLMM a DBT ST be ween-g oup e ec size d b [95% CI] Ou come and ime poin M[95% CI] wi hin-g oup e ec size d c [95% CI] M[95% CI] wi hin-g oup e ec size d c [95% CI] obse ed es ima ed d p BSI Baseline M= 1.94 e –Time −5.20 246 <0.001 0.31 0.5 yea s 1.64 [1.50; 1.79] 0.44 [0.01; 0.88] 1.77 [1.63; 1.92] 0.24 [−0.19; 0.68] 0.10 [−0.25; 0.46] −0.16 [−0.52; 0.19] T ea men a 1-yea FU 1.45 147 0.150 0.12 1 yea 1.49 [1.38; 1.61] 0.69 [0.25; 1.14] 1.64 [1.52; 1.77] 0.44 [−0.00; 0.88] 0.08 [−0.29; 0.45] −0.19 [−0.56; 0.19] Time × ea men 0.71 245 0.481 0.05 1.5 yea s (pos ) 1.35 [1.23; 1.48] 0.95 [0.49; 1.40] 1.53 [1.39; 1.67] 0.63 [0.18; 1.07] 0.10 [−0.34; 0.55] −0.15 [−0.60; 0.30] 0.5 yea s FU 1.23 [1.09; 1.39] 1.20 [0.73; 1.66] 1.42 [1.25; 1.61] 0.82 [0.37; 1.27] −0.07 [−0.56; 0.41] −0.20 [−0.68; 0.29] 1 yea FU 1.11 [0.95; 1.31] 1.45 [0.97; 1.93] 1.32 [1.12; 1.55] 1.01 [0.55; 1.47] 0.05 [−0.47; 0.57] −0.21 [−0.73; 0.31] QIDS−SR Baseline M= 16.26 e –Time −5.03 202 <0.001 0.33 0.5 yea s 14.27 [13.26; 15.35] 0.42 [0.08; 0.76] 14.30 [13.33; 15.33] 0.42 [0.08; 0.75] 0.20 [−0.16; 0.55] −0.01 [−0.36; 0.35] T ea men a 1-yea FU 1.35 147 0.179 0.11 1 yea 13.23. [12.33; 14.64] 0.67 [0.31; 1.02] 13.67 [12.77; 14.64] 0.56 [0.21; 0.90] 0.16 [−0.22; 0.53] −0.08 [−0.46; 0.29] Time × ea men 1.31 203 0.193 0.09 1.5 yea s (pos ) 12.26 [11.30; 13.30] 0.91 [0.52; 1.30] 13.08 [12.04; 14.20] 0.70 [0.30; 1.10] 0.11 [−0.34; 0.55] −0.08 [−0.53; 0.36] 0.5 yea s FU 11.36 [10.26; 12.59] 1.16 [0.73; 1.57] 12.51 [11.25; 13.90] 0.85 [0.41; 1.27] −0.07 [−0.55; 0.41] −0.12 [−0.61; 0.36] 1 yea FU 10.53 [9.27; 11.97] 1.40 [0.96; 1.83] 11.96 [10.46; 13.68] 0.99 [0.51; 1.46] 0.08 [−0.44; 0.60] −0.18 [−0.7; 0.34] WSAS Baseline M= 23.59 e –Time −2.39 411 0.018 0.12 0.5 yea s 18.93 [16.69; 21.48] 0.67 [0.23; 1.11] 21.23 [18.75; 24.03] 0.32 [−0.12; 0.76] 0.02 [−0.33; 0.38] −0.19 [−0.55; 0.16] T ea men a 1-yea FU −0.10 273 0.924 0.01 1 yea 18.45 [16.65; 20.11] 0.75 [0.30; 1.19] 20.04 [18.08; 22.22] 0.50 [0.05; 0.94] 0.10 [−0.27; 0.48] −0.12 [−0.50; 0.26] Time × ea men −0.89 412 0.374 0.04 1.5 yea s (pos ) 17.97 [16.28; 19.83] 0.83 [0.38; 1.28] 18.93 [17.07; 20.99] 0.67 [0.22; 1.12] 0.19 [−0.26; 0.64] −0.05 [−0.50; 0.40 0.5 yea s FU 17.51 [15.59; 19.66] 0.91 [0.46; 1.36] 17.88 [15.76; 20.25] 0.85 [0.22; 1.12] 0.12 [−0.36; 0.60] −0.02 [−0.50; 0.45] 1 yea FU 17.06 [14.72; 19.77] 0.99 [0.53; 1.44] 16.88 [14.39; 19.80] 1.02 [0.56; 1.48] 0.24 [−0.28; 0.75] 0.01 [−0.50; 0.53] DBT e sus Schema The apy in Bo de line Pe sonali y Diso de Psycho he Psychosom 2024;93:249–263 DOI: 10.1159/000538404 257 Downloaded om h p://ka ge .com/pps/a icle-pd /93/4/249/4272968/000538404.pd by Uni e si ä sbiblio hek Kiel use on 09 Sep embe 2024