Social Cognitive Treatment (T-ScEmo) for Various Neurological Patient Groups: Study Rationale and Protocol for a Randomized Control Trial (T-ScEmo4ALL)

Abstract

Background

Social cognitive impairments often occur in patients with various neurological disorders that involve brain damage, such as traumatic brain injury, stroke, brain tumours, and multiple sclerosis. Patients with social cognitive impairments experience difficulties in perceiving and understanding social information and show social inadequate behaviour. Recently, the first multi-faceted treatment, T-ScEmo (Treatment for Social Cognition and Emotion Regulation) has been developed and evaluated for patients with TBI. T-ScEmo showed to be effective in improving social cognitive functioning, participation, relationships, and quality of life. Up to now, no evidence-based treatment has been available for social cognitive impairments in neurological patients other than traumatic brain injury. Therefore, the main aims of the current study are to investigate the efficacy of T-ScEmo in various neurological patient groups such as stroke (including subarachnoid haemorrhage), brain tumours, and multiple sclerosis and to study factors that might influence this, potential, efficacy.

Methods

In this multi-centre, assessor-blind randomized controlled trial, 84 patients with mixed aetiology will be randomly divided over a treatment condition and a waiting list condition. Patients in treatment condition will follow twenty T-ScEmo sessions, of which five are online. Neuropsychological assessment and questionnaires directly after treatment (T1) and follow-up (T2, three to five months after treatment) will be compared to baseline assessment (T0). Ten TBI patients who receive T-ScEmo as regular rehabilitation care will be included as an extra control group. The main outcome measure will be the comparison of proxy rated behaviour between T0 and T2 on the Dysexecutive Questionnaire Social scales proxy version. Moreover, a compact barrier analysis is performed to facilitate the implementation of the treatment and to provide input for a process evaluation in the current study protocol.

Discussion

When T-ScEmo is proven effective based on the current study, this will be the first effectual evidence-based multi-faceted treatment for patients with social cognitive impairments caused by various neurological disorders. Implementation of this treatment is expected to contribute to better participation and better quality of life for patients and their significant others.

Trial registration

This study is prospectively registered in the database PaNaMa under number 202000479. Furthermore the study is registered in the database of clinicaltrials.gov (Study Details | Improving Social Cognition and Social Behaviour in Various Brain Disorders | ClinicalTrials.gov) under identifier NCT06330298.

Background

Social cognition

Neurological disorders that involve brain damage, such as traumatic brain injury (TBI), stroke, brain tumours, or multiple sclerosis (MS), often lead to impairments in cognition, emotion, and behaviour. Frequently, frontal-subcortical brain circuits are affected, which can lead to impairments in social cognition. These impairments are in turn considered to underly changes in social, interpersonal behaviours [1]. Due to these social cognitive impairments, patients with neurological disorders often have difficulties in different aspects of social cognition, such as perceiving social information (emotional expressions), understanding a social situation (i.e. mentalizing or Theory of Mind (ToM)), and/or reacting accordingly [2]. Henry et al. [3] emphasize that impaired social cognition can occur in many different brain disorders. Indeed, multiple studies show that social cognitive impairments are present in various neurological disorders such as TBI, strokes (including subarachnoid haemorrhages (SAH)), MS or brain tumours [3,4,5,6,7,8].

Changes in the social behaviour spectrum can vary from subtle to substantial. Patients can become disinhibited, blunt, extremely emotional, emotionally indifferent, or more self-centred. Moreover, patients with social cognitive impairments can have difficulties with showing empathy, conversational turn-taking, understanding jokes, and respecting personal boundaries [3]. Frequently, patients themselves are unaware of these impairments [9, 10]. These changes often lead to problems in communication, problems in engaging and maintaining relationships, and a lower quality of life, and consequently, reduce societal participation of patients [10,11,12,13]. This is a burden, both for patients themselves as well as for their significant others [10].

Treatment

Given all these negative consequences, there is a serious need for effective treatments for social cognitive disorders that target the broad range of social cognitive impairments to generate optimal generalisation in daily life. To date, multiple treatments for impairments in separate aspects of social cognition have been developed for TBI [14]. Up to now treatments for facial affect recognition [15,16,17] communication skills [18,19,20,21] perception [22] and perspective taking [23] have been developed and studied. Notable is that most of these treatments focus on only one aspect of social cognition; however, generalisation to other aspects of social cognition and more importantly, daily life, was mostly not demonstrated. The review of Vallat-Azouvi et al. [14], reported that treatment focusing on multiple aspects of social cognition proved to be more successful in enhancing multiple outcome measures of social cognition in daily life.

Westerhof-Evers and colleagues [9, 10] developed and evaluated a multi-faceted treatment for TBI patients with social cognitive impairments, T-ScEmo (Treatment of Social cognition and Emotion Regulation), with the overarching aim to improve social behaviour and social relations in daily life. In this treatment, patients focussed during three modules on aspects of social cognition (1. Recognizing emotional facial expressions, 2. Understanding social situations, and 3. Adjusting behaviour to the social situation). Results of this study show that patients improved on facial emotion recognition and ToM after receiving T-ScEmo. Moreover, patients improved their quality of life, social participation, as well as relation quality rated by their partners. These effects continued over a period of up to five months posttreatment [9].

These results are very valuable and promising. However, for patient groups other than TBI, there is no multi-faceted evidence-based treatment for social cognitive impairments available yet. Given the detrimental consequences of impaired social cognition [10,11,12,13], evidence-based treatment for all patients who experience these impairments is urgently needed in rehabilitation practice. Since social cognitive impairments are disorder-transcending to neurological disorders for example strokes, SAH, MS, or brain tumours [3,4,5,6,7,8] and can be found in various neurological patient groups, it is expected that the T-ScEmo protocol will be as effective in addressing these impairments and improving social behaviour.

Objectives

This new study aims to evaluate the efficacy of the T-ScEmo protocol, including new format e-health sessions, on improving social cognitive impairments, social behaviour and societal participation in various neurological patient groups, other than TBI patients, that are eligible for rehabilitation treatment, including patients with acute injury and more insidious diseases, as stroke, (including SAH) brain tumour, MS, and other neurological disorders that could affect social neuropsychological functioning such as Parkinson’s disease or inflammatory diseases. Moreover, we aim to find out which factors influence the efficacy of T-ScEmo. Therefore, multiple specific disease traits such as physical and cognitive functioning, fatigue, and treatment elements will be considered. In this study, the treatment protocol includes minor changes that have been made to the protocol based on the study of Westerhof-Evers et al. [9, 10], and considerations regarding how to learn from the implementation of the intervention in this study are discussed.

Methods

Study design

To evaluate the efficacy of T-ScEmo in various neurological patient groups, other than TBI, a multi-centre assessor-blind randomized control trial will be performed. Participating institutions are University Medical Centre Groningen (UMCG), UMCG Centre for Rehabilitation Location Beatrixoord (UMCG-CvR), and Deventer Hospital. The Medical Ethical Committee of the UMCG approved the study protocol (2020/596). All participating institutions approved the protocol. Patients and significant others will sign informed consent before participating, and all data will be obtained in compliance with the Helsinki Declaration.

Participants

In this study, patients with social cognitive impairments, eligible for rehabilitation treatment with one of the following neurological disorders; stroke (ischemic, haemorrhagic, including SAH), MS (both relapsing–remitting, primary and secondary progressive variants), brain tumours, and other categories of neurological disorders as infections (meningitis, encephalitis), post anoxic encephalopathy, Parkinson’s Disease (PD) will be involved. Patients are eligible for participation when social cognitive impairments shown on neuropsychological tests, namely, the Facial expression of emotion: stimuli and tests [24], Cartoons Test [25], Faux Pas Test [26] and/or the Hailing Sentence Completion Test. Impaired performance in more than one out of four tests is indicative of social cognition disorder. Moreover, when social behavioural problems are reported by patient or proxy on the Dysexecutive questionnaire social scales, Interpersonal Reactivity Index, Toronto Alexithymia Scale, The Dutch version of the BAFQ social scales or the Socioemotional Dysfunction Scale (> 1 of the (sub)scales of relevant questionnaires indicative).

In addition, 10 patients with moderate-severe TBI and social cognitive impairments, following the same criteria, will receive T-ScEmo as part of their regular clinical, evidence-based, rehabilitation treatment. These TBI patients are included to serve as a reference group and will make it possible to compare the results of the current study to the study of Westerhof-Evers et al. [9, 10].

For every patient that will participate in the study, a significant other will be included. The significant other will preferably be the patient’s life partner, however when no partner is available the significant other can be a family member (i.e. parent or sibling) or a close friend. The significant other can provide information about the patient, their relationship, and their own experiences concerning the patients’ situation and guide the patient during treatment. Inclusion criteria are presented in Table 1.

Table 1 Overview of inclusion and exclusion criteria

Procedure

Patients will be recruited in two ways: 1. From records of neuropsychological assessment in the UMCG and the Deventer Hospital, 2. Patients will be approached by their treating specialists (neurologist, rehabilitation physician or neuropsychologist) in the UMCG, UMCG-CvR, or Deventer Hospital if the presence of social cognitive problems is deemed likely.

After recruitment and signing written informed consent, patients will be invited for an extensive neuropsychological assessment (T0). Based on this assessment, final inclusion can take place. To investigate if other neuropsychological impairments will possibly be interfering with treatment, other cognitive domains are tested as well. The domains covered in the neuropsychological assessment are; social cognition, premorbid IQ, (mental) speed and attention, (working) memory, and executive functioning. When results of a previous, recent (within the last year) neuropsychological assessment are available, these can be used and only complementary tests are performed. All neuropsychological tests will be administered by a neuropsychologist or a trained assistant. After the test assessment patients and their significant others receive questionnaires about patients’ behaviour, mental state, relation quality, quality of life, participation, and burden of the significant other (see Table 2), to fill in at home, and send back by mail. If patients fulfil the inclusion criteria this T0 measurement will be used as a baseline measurement. After baseline measurement and inclusion, included patients will be randomly selected for treatment condition or waiting list condition, with a 50% chance for each condition drawn by lot. Patients will be informed about the result of this selection by phone. In the treatment condition, patients will start as soon as possible with T-ScEmo treatment, with the frequency of one, one-hour session per week, 15 of these and preferably given in the corresponding hospital (UMCG or Deventer Hospital), and the 5 online sessions, 20 sessions in total. If necessary or desirable, by means of distance or patients’ mobility, some of the 15 live sessions can be performed by a videocall. This will take three to four months. Directly after completion of the treatment, post-measurement 1 (T1) takes place, and after three to five months patients follow-up measurement (T2) to measure prospective long-term effects. Patients on the waiting list condition will be tested with the same intervals, so T1 takes place 3–4 months after baseline (T0), and T2 3–5 months after T1. During both post-measurements, only social cognitive functioning and questionnaires are administered (Table 2). All patients in the waiting list condition will be offered the possibility to follow the T-ScEmo treatment after having completed follow-up measurement (T2).

Table 2 Overview of Neuropsychological Tests and Questionnaires

TBI patients will receive treatment directly after T0, and will also undergo post measurements directly after completion of treatment (T1) and 3–5 months later (T2). A flowchart of the study procedure is presented in Fig. 1.

Fig. 1

Flowchart study procedure of the T-ScEmo4ALL study. Note. TBI = traumatic brain injury, T-ScEmo = Treatment Social cognition and Emotion regulation, NPA = Neuropsychological assessment

Main outcome

The main study outcome will be change in behaviour rated by the patients’ significant other. This will be measured by the difference score between baseline (T0) and follow-up (T2) on the Dysexecutive Questionnaire Social scales proxy version [9, 27] (DEX-Socproxy). These scales are clustered, originating from the Dysexecutive Questionnaire [28] (DEX), and measure social convention, behavioural-emotional self-regulation, and metacognition. The scale is scored on a five-point scale from 0 never to 4 very often and is scored by the patient’s significant other.

Sample size

The study of Westerhof-Evers et al. [9] found that the DEX-Socproxy had an effect size of Cohen’s d 0.2 (Cohen’s f 0.10) for the comparison between T0 and T2. From this data, a small to medium effect size of Cohen’s f 0.15 was estimated for the current study. Therefore the sample size of the current study is based on a power calculation for the main outcome measure (DEX-Socproxy). This is regarding the interaction of condition with time (T0, T2) using repeated measures analysis (with Effect Size Cohen’s f) 0.15, α 0.05 power 0.80 [29] results in a sample size of n = 62. However, to guarantee the distribution between the various patient groups a total sample size of n = 84 will be used: 42 patients per condition.

T-ScEmo protocol

The treatment consists of three modules covering the three main aspects of social cognition, during 20 sessions. The T-ScEmo treatment protocol is largely similar to the protocol extensively described in the paper of Westerhof-Evers and colleagues [10]. One minor change has been made to the format protocol based on patients’ experiences after the previous study (Westerhof-Evers et al., 2017). Since patients reported that the treatment was intensive, the new treatment protocol contains 15 live treatment sessions instead of 20, with the other 5 replaced by 5 e-health online sessions in which patients can practice from home with guidance from the neuropsychologist if necessary. The content of the sessions is the same as in the original protocol [10].

Treatment will be given by a trained and experienced (clinical) neuropsychologist. At the start of the treatment, patients will set three treatment goals, based on their own social cognitive functioning and personal problems experienced in daily life, and rate this goal on a scale from 1 to 10 utilizing the Goal Attainment Scale, which will be evaluated after finishing the treatment. After each session, patients will work on homework assignments which will help to implement the T-ScEmo content in daily life. Furthermore, the significant other is involved in about 2 to 5 of the treatment sessions depending on the patient’s needs and the availability. The significant other supports the treatment sessions by giving examples from daily life, practicing in roleplay, and is trained to give feedback on patients’ behaviour in daily life.

The protocol consists of three modules:

During module I perceiving social information (sessions 2–5 + online sessions 1–3) patients will learn to recognize the basic facial emotions: anger, fear, happiness, sadness, disgust, and surprise, and two complex emotions: embarrassment and contempt. This is taught by three different strategies 1. Facial feature processing, (session 2 and online session 1) 2. Mimicry (session 3 and online session 2) and 3. Emotional experiences (session 4).

In module II understanding social information (sessions 6–8) patients focus on how important it is to pay attention to the thoughts, feelings, and behaviour of one other. Patients learn with the help of the thoughts-feelings-behaviour (T-F-B) triangle to take different perspectives and how one’s own perspectives can differ from someone else’s (sessions 6 and 7).

In module III regulating behaviour in social situations (sessions 9–19 and online sessions 4–5) the first three sessions, patients will focus on improving socially desired behaviour with basic social skills such as communicating, listening, and personal space. Later in this module (session 12–19), patients will be working on individual behavioural problems in their daily life, such as anger management, responding to others’ emotions, and handling feedback. Not all sessions of this module will be carried out, approximately six to eight sessions will be specifically chosen based on patients’ needs and treatment goals. An overview of the treatment sessions and content is presented in Table 3.

Table 3 Content of T-ScEmo protocol

Data analysis

All data will be entered and stored using REDCap. After, the data will be analysed with the Statistical Package for Social Sciences (SPSS) version 28. Data gathered from the neuropsychological assessment will be controlled for age, sex, and educational level using norm-scores. Assumptions will be checked and descriptive statistics will be calculated and patient groups will be compared to each other using a T-test, or nonparametric test. When structural differences are noted in baseline demographical variables, these will be included as covariates in the subsequent analyses.

Whether the two groups differ on the main outcome measure, DEX-Socialproxy, at follow-up (T2) compared to baseline (T0), will be analysed by means of an ANOVA repeated measures analysis, or nonparametric variant. Complementary effect sizes will be taken into account. Additional repeated measures analyses, ANOVA, will be done for all secondary outcome measures at both time points (T1 and T2) comparing these with the baseline (T0). All statistical tests will be alpha 0.05, two-tailed.

Implementation

The goal of the current study, T-ScEmo4ALL, is to evaluate the T-ScEmo protocol to fit in the current evidence-based rehabilitation care for neurological patients with social cognitive impairments. If proven effective, widespread implementation of the T-ScEmo treatment will be expedient for these patients. In order to facilitate this process, we have conducted a compact barrier analysis and preparations for process evaluation [30].

Based on our previous study [9] we analysed and ordered which barriers and facilitators played a role in implementing the treatment. This was done with a well-structured checklist about mapping barriers and facilitators based on studies of Grol and Wensing [31], and Fleuren, Wiefferink and Paulussen [32], wherein possible barriers and facilitators of all types of end users (patients, significant others, therapists, referring physicians and institutions) were considered. Questions were grouped into four categories: the intervention (T-ScEmo), the end-users (therapists and other healthcare professionals, patients and significant others), the organisation (healthcare institutions), and the social-political environment, and were answered with yes (considered as enhancing factors/facilitators) or no (considered as limiting factors/barriers). Questions are as follows: “Is the innovation complete?”, “Is the innovation in line with the current approach?”, “Did the innovation arise from the work floor?”, “Are the necessary financial resources available to use the intended innovation?”. To investigate whether new barriers or facilitators arise when the intervention becomes available for new diagnosis groups and regarding the minor changes of the intervention itself (including the online sessions) a focus group with stakeholders was conducted. This panel consisted of 12 experts including four (clinical) neuropsychologists, one neurologist, two rehabilitation physicians, two patients, one significant other, and two implementation experts. During this focus group experts told their vision about themes such as online treatment sessions, recognizing social cognitive impairments, and the influence of COVID-19, using a semi-structured focus group script. The outcomes of the discussion were supplemented and supported with literature.

Barriers and implementation strategies

The identified barriers were grouped into three categories including the intervention itself, the end-users, and ‘the organisation’ as in the institutions that facilitate the treatment. The results of the compact barrier analysis based on the previous study, the results of the focus group, and the literature, led to tailored implementation strategies. It is described in which way the barriers and or strategies are taken into account within the process evaluation.

Intervention

Online sessions

Experts in the focus group mentioned two important barriers considering this theme: digital skills and motivation. Regarding the first aspect of computer ignorance, not all people are embedded in the new digital world. Besides, patients with brain damage and their cognitive and physical consequences such as problems with sight, speed of information processing, or attention can experience difficulties using a computer. Regarding the second aspect, motivation, experts mentioned that patients can have diminished motivation when they have to start a treatment session themselves. Motivation plays a key role in e-learning [33]. Especially patients with social cognitive problems can experience motivational difficulties [3].

Based on these two concerns we decided that it is an option to replace the online sessions with live sessions when needed. In addition, the online sessions are scheduled in patients’ calendars as regular sessions. During this one-hour session, therapists are standby at a distance to assist by phone or video call when needed. In addition, patients can borrow a tabled, if necessary, and have to bring and discuss the results of the online sessions with the therapist which may contribute to enhancing an extrinsic motivation.

In the process evaluation, we will monitor if and how many online sessions were performed and if patients made use of the standby position of the therapist. After the treatment, we will ask each patient in a semi-structured interview how they experienced the online sessions or if patients would have preferred live sessions. Furthermore, the therapists will be asked about their experience with online treatment.

COVID-19

The expert panel discussed the impact of the COVID-19 restrictions on the treatment. The experts mentioned that facemasks make it hard for patients to practice the module on emotion recognition. They miss emotional facial expressions made by their therapist but also in real-life practice. Besides, physical restrictions and quarantine rules make it difficult to follow a 20-week during treatment in a hospital. On the other hand, due to the COVID-19 pandemic, it has become more common to create a videocall which creates more possibilities for practicing T-ScEmo online. The benefit of an online treatment session is that the patient is in his own surroundings. Where a clinical setting can create a bias in which people have to behave a certain way, patients often show more of their daily behaviour in their own environment. This could lead to more insight into the patient’s behaviour and more specific guidance.

In the process evaluation, we will monitor how many patients follow treatment during COVID-19 restrictions, what restrictions are valid at that time, and how this influences the treatment. Patients and therapists will be asked about their experiences while following and giving the treatment during the pandemic.

End-Users

The expert panel mentioned that an important barrier to referral to this treatment is the recognition of social cognition impairments. These impairments are often not properly recognized by referring neurologists and rehabilitation physicians. Recognizing or assessing social cognitive impairments can be challenging for clinical neuropsychologists as well [34]. When these social cognitive impairments remain unnoticed patients will lose treatment opportunities which can lead to social isolation [10,11,12,13]. It is, for this reason, important that these problems are acknowledged in the rehabilitation process.

Therefore, a social cognition impairments identification list will be redesigned and will be shared with physicians and neuropsychologists during the current study period. In the process evaluation, we will evaluate whether the social cognitive impairments identification list helps the referring neurologists, rehabilitation physicians, and psychologists in recognizing social cognitive problems within their patient population by semi-structured interviews and if or which improvements of the list are needed.

Before the T-ScEmo study can be performed the therapist needs to be informed and trained in the T-ScEmo protocol because of the multi-faceted aspects of the protocol. It is important that the therapist knows about the opportunities that the treatment can bring and the path to choose that fits best with the various types of patients. Therefore, training in the current treatment protocol is arranged for the clinical neuropsychologists who participate in the current study. Halfway through the study an evaluation moment will be organised to make sure that the therapist keeps following the treatment protocol and performing the treatment in the same way.

Organisation

The T-ScEmo protocol has been shortened in the current version. Still, it encompasses 15 to 20 treatment sessions. This could be a barrier for some institutions in which T-ScEmo could be implemented. Due to the restricted available time per patient, it can be expensive for the organisation to perform a long treatment protocol.

One result will be a paper that will analyse the effectiveness of T-ScEmo, which patients benefit most and which patients will not benefit from the treatment. Moreover, to measure the average time and most efficient use of the treatment it will be monitored which specific treatment sessions are chosen the most and what the average duration (time in months) of the treatment will be. In this way, we will provide valuable information which health care professionals can use to prioritise what combination of sessions can be used in the restricted time given. With this information and profile per patient, it is possible to choose T-ScEmo as a well-considered treatment option.

Process evaluation

For the process evaluation we will monitor and evaluate quantitative and qualitative data during and after the implementation process [30]. Quantitative data that we will evaluate exist of the mean duration of the treatment procedure, the most followed treatment sessions, how many online sessions were followed, if and how many times help was needed during an online session, how many times a close other was involved, et cetera. Qualitative data include interviews with patients, therapists, other healthcare professionals and the focus group about recognizing social cognitive impairments, online treatment sessions, progression and intensity.

Discussion

Up to now no effective evidence-based treatment for neurological patients with social cognitive impairments other than TBI is available. This current study protocol is the first to investigate the efficacy of a multi-faceted social cognition treatment in several neurological patient groups. Since the study of Westerhof-Evers et al. [9, 10] proved the effectivity of T-ScEmo in TBI patients and social cognitive impairments are disorder-transcending, comparable results are expected.

Compared to the previous study [9] one minor, though important, change to the treatment protocol has been made. By turning 5 out of 20 sessions into online e-health sessions the treatment will hopefully be less intensive while the content of the treatment does not differ from its origin. However, no statements can yet be made about the online sessions and their influence on the effectiveness of the T-ScEmo protocol. To control for the effects of this adjustment TBI patients are included in the current study. In this way, we are able to analyse the effectiveness of the renewed treatment protocol.

A difference regarding the study protocol compared to the study of Westerhof-Evers et al. [9] is the waiting list condition. Where the previous study used a control treatment to compare with T-ScEmo, the current study compares the expected effects to a waiting list condition in which patients receive no specific treatment or therapist contact. It could be argued that comparing treatment to a waiting list could lead to a bias. However, in this study design a waiting list was chosen because other treatment approaches for social cognition have not been found to be effective in generalisation to daily life [9, 10, 14]. It would be ethically unjustified to let patients commit to a control treatment for 20 weeks which is known to be unsuccessful. Therefore, we argue that the waiting list condition is the best solution for this study.

Although we consider social cognitive impairments to be disorder transcending, patients with different aetiologies might still diverge in the way that other (such as cognitive, physical, and energetic) symptoms present. Hence, the effectiveness of the protocol may vary within and between patient groups. Therefore, disease-specific characteristics and how this influence treatment participation are monitored during the study. Hopefully, this results in a protocol that can be adapted for specific social cognitive impairments and also for patients’ specific situations.

Regarding the implementation of the treatment protocol, there are some barriers to keep in mind during this study. We are aware of these barriers and are actively working to anticipate solutions that we incorporate and monitor throughout this study. Data of the process evaluation during and after the trial will be used to try to understand the outcome of effectiveness of the study and to provide recommendations for wider implementation.

In summary, the goal of this study is to evaluate the multi-faceted T-ScEmo treatment in various neurological patient groups that are eligible for rehabilitation treatment and to determine which factors influence the efficacy of T-ScEmo. This hopefully will lead to a fitting and evidence-based treatment option for social cognitive impairments in various neurological patient groups.