Mie Poulsgaard Jørgensen, Psykolog og ph.d studerende i Børne- og Ungdomspsykiatrien Region Sjælland

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1 Evidensgrundlaget for mentaliseringsbaseret terapi - hvor står vi? Mie Poulsgaard Jørgensen, Psykolog og ph.d studerende i Børne- og Ungdomspsykiatrien Region Sjælland

2 Hvem er jeg? Uddannet psykolog fra Aalborg Universitet Flere års klinisk erfaring med personlighedsforstyrrelser og PTSD i psykiatrien Siden 2016 været ansat i Børne- og Ungdompsykiatrien i Region Sjælland på M-GAB projektet (mentaliseringsbaseret gruppeterapi til unge med borderline eller subtærskel borderline personlighedsforstyrrelse) og er nu i gang med Ph.d studium

3 Dagsorden Hvad er evidens? Risk of bias i randomiserede kontrollerede forsøg Hvad er status på mentaliseringsbaseret terapi gennemgang af studier Hvilke spørgsmål mangler vi stadig at besvare? Opsummering og spørgsmål

4 Alle informationer i dette oplæg er baseret på det igangværende arbejde med opdateringen af Cochrane reviews for psykoterapier til borderline personlighedsforstyrrelse Resultaterne er derfor præliminære! Protokol: Storebø OJ, Stoffers-Winterling JM, Völlm BA, Kongerslev MT, Mattivi JT, Kielsholm ML, Nielsen SS, Jørgensen MP, Faltinsen EG, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database of Systematic Reviews 2018, Issue 2. Art. No.: CD DOI: / CD

5 Hvad er evidens? Klinikerens faglige vurdering baseret på erfaring Behandling (Ekstern) Evidens Patientens præferencer

6 Evidenshierarki

7 Randomiseret kontrolleret forsøg Behandling Udfald Udfald

8 Risk of bias Random sequence generation Allocation concealment Blinding of participants and personnel Blinding of outcome assessments Incomplete outcome data Selective reporting Other sources of bias (f.eks. adherence, allegiance, attention bias)

9 Gennemgang af forsøg med MBT

10 Overblik over randomiserede kontrollerede forsøg med MBT I forbindelse med Cochrane reviewet har vi via systematiske søgninger kunnet finde følgende randomiserede kontrollerede forsøg med MBT: Forfattere Titel Antal publikationer på forsøg Bateman, Fonagy Bateman, Fonagy Jørgensen CR, Freund C, Bøye R, Jordet H, Andersen D, Kjølbye M. Paul Robinson, Jennifer Hellier, Barbara Barrett, Daiva Barzdaitiene, Anthony Bateman, Alexandra Bogaardt, Ajay Clare, Nadia Somers, Aine O Callaghan, Kimberley Goldsmith, Nikola Kern, Ulrike Schmidt, Sara Morando, Catherine Ouellet- Courtois, Alice Roberts, Finn Skårderud & Peter Fonagy TrudieI.Rossouw, Peter Fonagy Effectiveness of Partial Hospitalization in the Treatment of Borderline Personality Disorder: A Randomized Controlled Trial Randomized Controlled Trial of Outpatient Mentalization- Based Treatment Versus Structured Clinical Management for Borderline Personality Disorder Outcome of mentalization-based and supportive psychotherapy in patients with borderline personality disorder: a randomized trial The NOURISHED randomised controlled trial comparing mentalisation-based treatment for eating disorders (MBT- ED) with specialist supportive clinical management (SSCM- ED) for patients with eating disorders and symptoms of borderline personality disorder Mentalization-Based Treatment for Self-Harm in Adolescents: A Randomized Controlled Trial 3 (1999, 2001, 2003) 3 (2009, 2013, 2016) 2 (2013, 2014) 1 (2016) 1 (2012)

11 Bateman & Fonagy, 1999 Metode Setting Country Recruitment Participants included Number of withdrawals Inclusion criteria Exclusion criteria Outcomes under review 18 month trial with two arms: - Mentalization-based treatment - Standard treatment Partially hospitalised/outpatient UK General psychiatric services 44 (22 females) 6 (drop-outs were not included in analysis) BPD Psychotic disorder, bipolar I disorder, opiate dependence requiring specialist treatment, mental impairment, evidence of organic brain disorder, being in long-term psychotherapeutic treatment Interpersonal problems, depression, anxiety, general psychopathology, self-harm, suicide attemppts

12 Bateman & Fonagy, 1999 Risk of bias Item Quote Risk of bias (low, unclear, high) Random sequence generation Minimisation Low Allocation concealment Central allocation Low Blinding of outcome assessment Incomplete outcome data Selective outcome reporting Other sources of bias Blinded assessments - - No published protocol Adherence: low Allegiance: high Attention: High Low Unclear High

13 Forfatternes kernekonklusioner: Styrker: MBT viste signifikante forbedringer på symptomer og kliniske mål -- - for begge køn Forskellen opstod i de sidste 6 måneder af behandlingen (brug for længere behandlingstilbud) Kun tre droppede ud af behandlingen i MBT Svagheder Lille sample size

14 Bateman & Fonagy, 2009 Metode Setting Country Recruitment Participants included Number of withdrawals Inclusion criteria Exclusion criteria Outcomes under review 18 month trial with two arms: - Mentalization based treatment - Structured clinical management Outpatient UK Clinical services 134 (107 females) 35 (19 in MBT, 16 in SCM) BPD. Suicide attempt or episode of life-threatening self-harm in past 6 months, age In long-term psychotherapeutic treatment, psychotic disorder or bipolar I disorder, opiate dependence requiring specialist treatment, mental impairment or evidence of organic brain disorder Interpersonal problems, depression, general psychopathology, suicidal ideation, self-harming behavior, mental health status

15 Bateman & Fonagy, 2009 Risk of bias Item Quote Risk of bias (low, unclear, high) Random sequence generation Minimisation Low Allocation concealment Offsite Low Blinding of outcome assessment Incomplete outcome data Selective outcome reporting Other sources of bias Blinded assessments - - Published protocol is followed Adherence: low Allegiance: high Attention: low Low Low High

16 Forfatternes kernekonklusioner: Styrker Begge behandlingstyper havde effekt. MBT havde større effekt end SCM ift. selvmordsforsøg, selvskade og på selvrapportering Uselekteret gruppe til forsøget MBT synes mere hjælpsom end generisk psykoterapi Begge terapiformer blev leveret af professionelle (trænet på samme niveau) Svagheder Forfatterne har udviklet terapiformen Ikke målt på prædiktorerne for effekt af behandling

17 Jørgensen et al., 2013 Metode Setting Country Recruitment Participants included Number of withdrawals month trial with two arms: - Combined MBT-treatment - Supportive group treatment Outpatient Denmark From outpatient clinics, community psychiatric wards and psychiatrists in private practice 111 (74 MBT, 37 control) (106 females) 35 in MBT, 18 in control Inclusion criteria DSM-IV diagnosis of BPD. Age > 21, GAF > 34 Exclusion criteria Outcomes under review Diagnosis of antisocial or paranoid PD, severe substance abuse, age < 21 BPD severity, Mental health status, Anger, Interpersonal problems, Depression, Attrition

18 Jørgensen et al., 2013 Risk of bias Item Quote Risk of bias (low, unclear, high) Random sequence generation Insufficient information Unclear Allocation concealment Insufficient information Unclear Blinding of outcome assessment No blinding High Incomplete outcome data High rate of attrition High Selective outcome reporting Other sources of bias No published protocol Adherence: no, unclear Allegiance: low Attention: more in MBT, high Unclear High

19 Forfatternes kernekonklusioner: Styrker Signifikant effekt af både MBT og kontrolbehandling med store effektstørrelser i begge grupper Højere GAF score i MBT gruppe, ingen signifikante forskelle på andre outcomes Svagheder Inkluderede ikke systematiske monitoreringer af behandlinger Skewed randomisering (flere i MBT end kontrol) Outcomes baseret kun på selvrapportering

20 Robinson et al., 2016 Metode Setting Country Recruitment Participants included Number of withdrawals Inclusion criteria 1 year trial with two arms: - MBT for eating disorders - Specialist supportive clinical management for eating disorders Outpatient UK From clinical centers 68 (92.7% females) 21 dropped out of therapy (12 in MBT, 9 in control) Completed follow-up 18 months: 10 in MBT, 5 in control Completed follow-up 36 months: 10 in MBT, 9 in control Age > 18, DSM-IV eating disorder, DSM- IV BPD or BPD symptoms, impulsivity in at least 2 areas that are potentially selfdamaging, recurrent suicidal or selfmutilating behavior

21 Robinson et al., 2016 fortsat Exclusion criteria Outcomes under review Current psychosis, current inpatient or day-patient, currently in other therapy, received MBT less than 6 months prior to randomization, organic brain disease leading to significant cognitive impairment or BMI < 15 BPD severity, mental health status, Affective instability, Chronic feelings of emptiness, interpersonal problems, abandonment, identity disturbance, depression, attrition, attrition, adverse effects

22 Robinson et al., 2016 Risk of bias Item Quote Risk of bias (low, unclear, high) Random sequence generation Block randomisation Low Allocation concealment Insufficient information Unclear Blinding of outcome assessment Incomplete outcome data Selective outcome reporting Other sources of bias Blinded assessments High attrition Published protocol is followed Adherence: low Allegiance: high Attention: more in MBT: high Low High Low High

23 Forfatternes kernekonklusioner: Styrker: Hos de der gennemførte behandlingen var MBT-ED associeret med større reduktion i Shape concern & Weight Concern end hos kontrolgruppe Svagheder: Højt drop out (kun 22% gennemførte follow-up). Tidlig drop-out forekom mere i kontrolgruppe. 10 patienter havde iagtrogene effekter under behandlingen (selvskade og en der døde i MBT-ED)

24 Rossouw & Fonagy, 2012 Metode Setting Country Recruitment Participants included 1 year trial with two arms: - MBT for adolescents - Treatment as usual Outpatient UK Number of withdrawals 43 Inclusion criteria Exclusion criteria Outcomes under review Community mental health services 80 (68 females) Age 12-17, at least one confirmed intentional selfharm within the past month Psychosis, IQ < 65, pervasive developmental disorder, eating disorder in the absence of selfharm, chemical dependence BPD severity, self-harm, depression, attrition

25 Rossouw & Fonagy, 2012 Risk of bias Item Quote Risk of bias (low, unclear, high) Random sequence generation Minimization Low Allocation concealment Envelopes Low Blinding of outcome assessment Incomplete outcome data Selective outcome reporting Other sources of bias Blinded assessments High attrition rate Published protocol has outcomes that are not reported in publication Adherence: applied but results not presented: unclear Allegiance: high Attention: equal: low Low High High High

26 Forfatternes kernekonklusioner: Styrker Begge grupper profiterede af behandling MBT-A havde bedre recovery rate (44% versus 17% i TAU) Første forsøg til unge med BPD, der viser større effekt af eksperimentel intervention overfor kontrolgruppe i forhold til reduktion af selvskade og depression Svagheder Lille sample size Svært at tolke resultater vedrørende risikotagning grundet forskelle ved baseline Kontrolintervention var ikke manualiseret Ugentlig supervision i MBT-A gruppe kan have påvirket outcome Resultaterne udsprang fra én organisation à svært at generalisere

27 Opsamling hvor er vi? Vi har endnu ikke lavet metaanalyse på MBT studier: derfor kvalitativ vurdering! MBT synes at have en god effekt, særligt efter 12 måneders behandling Stadigt kun få forsøg karakteriseret ved relativt små samples Behov for flere forsøg af høj kvalitet Særligt behov for uafhængige forsøg (uden allegiance bias) og forsøg hvor der er nok power (nok personer), som tager højde for drop-out hos denne gruppe af patienter

28 Spørgsmål Del gerne jeres tanker og kommentarer til inspiration Tak!