Narrative enhancement and cognitive therapy (NECT) to improve social functioning in people with serious mental illness: study protocol for a stepped-wedge cluster randomized controlled trial

Eligible participants will be adults (age > 18) diagnosed with schizophrenia, schizoaffective disorder, schizotypal disorder, schizophreniform disorder, bipolar I or II disorder or borderline personality disorder (DSM-5 criteria [41]). For the purpose of the study only stabilized outpatients will be recruited (defined as 3 months of clinical stability and no changes in pharmacological treatment in the past 3 months). Participants unable to give informed consent or with a comorbid intellectual disability will be excluded. Participation in other programs having an impact on social function or self-stigma (social cognitive remediation, social skills training) will be prohibited during the follow-up period.

Patients diagnosed with schizophrenia, bipolar disorder or borderline personality disorder (DSM-5 criteria [41]) will be recruited through six Rehabase psychiatric rehabilitation network centres [36], three FondaMental Academic Centres of Expertise (FACE) for SZ or BD [42, 43], one unit specialized in mood disorders at the Geneva university hospital, one psychiatric day-care clinic specialized in mood and personality disorders in Grenoble and one psychiatric rehabilitation centre located in the psychiatric hospital in Caen. The selected sites are already actively involved in treating patients with SZ, BD or BPD and have previous research experience in the field of psychiatric rehabilitation. Regular group meetings will be organized to monitor quality control and ensure good inter-rater reliability. A list of eligible participants will be generated under the supervision of the coordinating centre clinical research officer. Each eligible patient will be approached by a trained member of the research team and invited to participate in the study, thereby eliminating selection biases. Eligible patients will be given a leaflet describing the program and the research. Informed consent will be taken during a medical interview with one of the investigators. The clinical research officer of the coordinating centre (Grenoble) will be in charge of the randomization process for participants from all centres. Clusters will be randomized to receive the intervention at either T0 or T1. Stratified randomization will be used to ensure that cluster types are well balanced across groups. Outcomes will be compared in all groups at T0 and T1 (duration of intervention= 6 months). Six-month and 12-month outcomes for groups 1 and 2 will be measured at T2 (18 months after T0) to evaluate the stability of the effects over time. A 7-point improvement in social functioning measured using Personal and Social Performance Scale [44] (PSP) is generally considered as clinically significant. We plan to include 5 patients per centre and per group, meaning that there will be 10 participants included per centre for a total of 120 patients included (60 in group 1, 60 in group 2). This sample size was calculated using R package ‘pwr’ [45] based on Cohen [46] (d = 0.50, alpha level of 0.05) without allowing for intra-cluster correlations and the cluster and time effects found in stepped-wedge designs [47, 48]. This could be a considerable limitation, as it might have underpowered the trial [47]. Most of the outcome measures are self-rated questionnaires; the other evaluations will be conducted by an evaluator who has not taken part in the intervention. The schedule of enrolment, interventions and assessments is shown in Fig. 3 (SPIRIT diagram).

A consistent translation and cross-cultural adaptation procedure was realized by two independent research teams (JD, MF and MA in Grenoble; HRL, SF and FJ in Geneva). All materials were translated from English into French, the first language of all translators. Each team reviewed the material translated by the other team so all translations were crosschecked. Regular group meetings between the two teams were conducted to discuss any problematic translations and resolve any disputed items, in line with established translation methods.

All the clinicians involved will attend a 1-day NECT training session, delivered by the creators of the program (Yanos PT, Roe D). Training will include discussion and role-playing exercises, with corrective feedback from the trainers. Regular group supervisions will be organized to ensure treatment fidelity. NECT fidelity will be monitored using the NECT Fidelity Scale, developed by Yanos et al. [34].

The French adaptation of NECT is a manualized, structured, 12-session, group-based intervention conducted by two facilitators. The number of sessions was reduced in the French adaptation and their duration extended to match the typical duration of psychosocial interventions in French-speaking countries (up to 15 sessions). Figure 4 provides an overview of the NECT topics. The 2-h sessions are divided into three main parts: (1) psychoeducation about stigma, self-stigma and myths about mental disorders; (2) cognitive restructuring targeting negative thoughts about the self and dysfunctional attitudes and (3) story-telling exercises in which participants tell stories about themselves, receive feedback from other group members and facilitators and are invited to apply the cognitive restructuring skills learnt in the previous sessions to their personal life narratives. At-home practice exercises are carried out between the sessions.

Social function will be assessed with the Personal and Social Performance Scale [44] (PSP), a clinician-reported measure of social dysfunction using six-point severity scale in four life domains (socially useful activities, personal and social relationships, self-care and disturbing or aggressive behaviours). PSP provides an overall rating score ranging from 1 to 100, higher scores representing better personal and social functioning. PSP showed acceptable internal consistency [52], excellent inter-rater reliability [53] and a satisfactory ability to detect changes [44]. A seven-point improvement during clinical trials is considered to be clinically significant [44].

Self-stigma will be assessed using the Internalized Stigma of Mental Illness scale (ISMI [2, 54]), a 29-item self-report measure designed to assess a person’s personal experience of stigma related to mental disorders and is rated on a four-point Likert scale. Items are summed to provide a mean total score and five subscale scores (alienation or feeling of being a devalued member of the society; stereotype endorsement or agreement with the negative attitudes about SMI; discrimination experience; social withdrawal as a coping strategy and stigma resistance). Stigma resistance is generally excluded because of poor correlations with other subscales [32, 34]. Higher scores reflect higher levels of self-stigma. Scores above 2.5 indicate moderate to high levels of self-stigma [2, 3]. Illness severity will be assessed in patients with SZ using the Positive and Negative Syndrome [55] (PANSS) scales. Current depressive symptoms were evaluated using the Montgomery-Asberg Depression Rating Scale [56] (MADRS) and current manic symptoms with the Young Mania Rating Scale [57] (YMRS). Insight and treatment adherence will be assessed with self-reported measures (Birchwood Insight Scale (BIS) [58]; Medication Adherence Rating Scale (MARS) [59]). Quality of life will be evaluated with the self-reported Subjective Quality of Life scale [60] (S-QoL) and wellbeing using the Warwick-Edinburgh Mental Well-being Scale [61] (WEMBS). Self-esteem will be measured with the Self-Esteem Rating Scale [62] (SERS) and personal recovery using the self-reported Stage of Recovery Instrument [63] (STORI). Baseline neuropsychological cognitive assessments include Wechsler Adult Intelligence Scale-4th edition [64] (WAIS-IV) subscales assessing working memory, verbal abstraction and hypothetico-deductive reasoning, BEM-144 story subtest for auditive-verbal memory [65], Trail Making Test A and B (TMT-A or B) [66] respectively for speed of processing and reactive mental flexibility, D2-R for selective attention, concentration and speed of processing [67], and shopping test for planning abilities [68]. Theory of mind will be assessed at baseline using the Versailles-Situational Intention Reading Test [69] (V-SIR).