Van Dijk 2019.

Study name	Group schema‐focussed therapy enriched with psychomotor therapy for older adults with personality disorders in specialised mental health care: a (cost‐)effectiveness study
Methods	Design: multicentre randomised trial
Participants	Participants: older persons, with a cluster B or C personality disorder or meeting the general criteria for a personality disorder, treated in specialised mental health care settings Age: 60 years or older Unit of allocation: stratified block randomisation to assign participants evenly (1:1) over the two conditions (stratified by presence of a full versus subthreshold cluster B or C personality disorder) Target sample size: 140 Inclusion criteria: age of 60 years or above; cluster B or C personality disorder (or falling one content criterion short) as confirmed by the Structured Clinical Interview for DSM‐5 for personality disorders (SCID‐5‐PD); mentally able to adhere to the group SFT treatment schedule and to fill out the schema questionnaires; able to give informed consent after having received oral and written information Exclusion criteria: severe current mental illness, including bipolar I disorder, psychosis, or substance abuse disorders needing clinical detoxification; an established neurodegenerative disorder; cognitive impairment defined as a sum score below 23 points on the Montreal Cognitive Assessment (MoCA) battery; having received schema‐focussed therapy in the previous year or during the current illness episode; suicide risk interfering with adequate treatment delivery
Interventions	Two conditions: group schema‐focussed therapy enriched with psychomotor therapy (group SFT + PMT); or treatment‐as‐usual (TAU) Experimental group: group SFT + PMT Control group: TAU Details of conditions: Group schema‐focussed therapy with psychomotor therapy is delivered in 18 weekly and 2 follow‐up sessions (at weeks 22 and 26); consists of 2‐hour group schema‐focussed therapy and 1‐hour psychomotor therapy; group schema‐focussed therapy focuses on the cognitive behavioural techniques of schema therapy; psychomotor therapy uses physical exercises to facilitate the experience of patients’ typical cognitions and behaviours TAU is unrestricted. Duration of intervention: 18 weeks (plus 2 individual pre‐treatment sessions without PMT, to make a personal treatment plan and explain the concept of group SFT + PMT in more detail) Duration of trial: 26 weeks Length of follow‐up: unclear: the protocol reports follow‐up at 6 months and 12 months; the clinical trials register reports there are two follow‐up sessions, 1 at week 22 and 1 at week 26, i.e. 8 weeks post‐intervention
Outcomes	Primary outcomes of trial: Psychological distress: assessed with the Brief Symptom Inventory‐53‐item version (BSI‐53) Cost‐effectiveness analysis: health‐related quality of life is assessed with the EuroQoL (EQ‐5D‐5L) Cost‐effectiveness: medical consumption and other cost data gathered by structured patient interview Secondary outcomes of trial: Life satisfaction: Cantril's Ladder ‐ a single self‐report question to rate one’s current life situation on a scale (from 0 to 10), where a score of 0 indicates ‘the worst possible life for you’ and 10 ‘the best possible life for you’ Mental well‐being: assessed using Warwick‐Edinburgh Mental Wellbeing Scale (WEMWBS) Personality functioning: assessed using Severity Indices of Personality Problems–Short Form (SIPP‐SF) Interoceptive body awareness: assessed using Multidimensional Assessment of Interoceptive Awareness (MAIA) Substance use: psychotropic drug use and treatment received Mental state (mood variability): using Mood‐Zoom, an experience sampling method for real‐time mood assessment on a smart‐phone Other outcomes of trial: none
Starting date	2017‐08‐01
Contact information	Name: M.S.Veenstra Email: m.s.veenstra@umcg.nl Phone: +31 50 3612079 University Medical Center Groningen, Department of Psychiatry, P.O. Box 30.001, 9700 RB, Groningen, The Netherlands
Notes	Current trial ID: NL6443 Old trial ID: NTR6621