Ethical statement

This study was ratified by the ethics committee of The Second People’s Hospital of Guizhou Province (approval number: 2020018). Informed consent was signed by the families of all participating patients. This study was conducted in Guizhou, China.

General demographic characteristics

From September 2020 to October 2021, 78 schizophrenia patients admitted to The Second People’s Hospital of Guizhou Province were divided by the random number table method into a control group and an observation group with 39 cases each. The discrepancies of general demographic characteristics between the two groups were not significantly great (p>0.05), which was comparable (Table 1).

Table 1.

Comparison of general demographic characteristics between the two groups

Inclusion criteria

① Well-defined diagnostic criteria for schizophrenia (Dilling & Dittmann, Reference Dilling and Dittmann1990). ② Age ranging from 18 to 40 years old. ③ First episode, confirmed no issues with antipsychotic drug tolerance. ④ Stable basic vital signs of the patient, with no impediments in verbal expression and basic limb activities. ⑤ Assessed to have no severe suicidal ideation, aggressive behaviour, or acute mental symptoms. ⑥ The patient himself/herself or the legal guardian agreed to participate in the study and able to cooperate with the treatment and assessment process of the study. ⑦ Approved by hospital ethics.

Exclusion criteria

① Concurrent with other mental disorders, such as bipolar disorder, depression, anxiety disorder, mental retardation, drug dependence, etc. ② Complicated with severe neurological diseases, such as epilepsy, cerebral infarction, Parkinson’s disease, Alzheimer’s disease, and other neurological diseases that might significantly affect cognitive function. ③ Pregnancy or lactation period. ④ Poor adherence to medical advice or recent receipt of other psychological treatments. ⑤ Assessed to have severe cognitive deficits or inability to understand the treatment content and scale tests normally. ⑥ Presence of alcoholism, drug abuse, or psychotropic drug misuse. ⑦ Concurrent participation in other intervention studies or withdrawal due to various factors.

Methods

(1) Control group: Oral administration of aripiprazole (Shanghai Shangyao Chinese-Western Pharmaceutical Co., Ltd.; No. H20041506; Specifications: 5 mg). The initial dose was taken once daily, 5–10 mg each time. The dosage could be adjusted according to the patient’s condition, and the increased dosage should not exceed 30 mg/d. This treatment lasted for 3 months. Conventional interventions during the treatment period included enhancing communication with the patients after admission, providing understanding, support, and attention with a warm and empathetic attitude; increasing awareness of schizophrenia and helping patients normalise their individual situations, ensuring they fully understand and correctly recognise the psychotic symptoms they are experiencing, thereby reducing the impact on related functions and psychological well-being; encouraging family members to provide more understanding, care, and companionship to the patients; and assisting in improving the intimacy between the patients and their family members to boost their confidence in life.

(2) Observation group: Treatment of CBT combined with aripiprazole. CBT: A CBT team was established, consisting of one clinical doctor, one psychological counsellor, and three specialised nurses. All team members possessed relevant qualifications in psychological therapy, had received professional training, and passed the assessments. The team participated in weekly case supervision sessions. The team members provided CBT to the patients. ① Symptom education: Patients were guided to understand the characteristics, symptom types of the disease, and its impact on life. For example, the biological and psychological causes of schizophrenia were explained to the patients; patients were made aware that symptoms such as hallucinations and delusions were pathological rather than realistic events; the patient was empowered to better understand and feel less ashamed about the disease. ② Early symptom identification: Patients and their family members were guided to identify early signs of disease recurrence. For example, by recalling the medical history, patients were guided to discover early symptoms (such as depression, sleep disorders, or decreased attention). ③ Medication compliance intervention: Patients were educated to know better about the importance of medication and act in accordance with their doctors. For example, patients were told about the possible positive and side effects of drugs to eliminate misunderstandings or fears; patient’s medication was recorded, difficulties in the treatment were discussed, and problems were solved with joint efforts; a reasonable medication plan was formulated and reminder mechanisms (such as pill boxes or mobile phone alarms) were set up. ④ Intervention for hallucinations: Patients were helped to re-evaluate the source and meaning of the heard voices or other hallucinations. For example, patients were taught to use the ‘voice discrimination’ technique (distinguishing hallucinations from real sounds); patients were guided to record the frequency, time, and triggers of hallucinations so as to identify their regularity; patients were guided to view hallucinations as ‘bystanders’ to reduce emotional responses. ⑤ Intervention for delusions: Patients were helped to challenge and correct the unreasonable belief system (such as persecution delusions and grandiosity delusions). For example, patients were guided to discuss the specific content of their delusions and explore whether these beliefs were logical through questioning; patients were asked to list the evidence supporting and refuting the delusions to help them understand their cognitive biases through the evidence comparison method; patients were encouraged to use alternative explanations (such as thinking of ‘maybe a coincidence’ instead of ‘being monitored’). ⑥ Emotional regulation: Patients were helped to regulate adverse emotional states. For example, relaxation training, such as deep breathing, muscle relaxation, and mindfulness meditation, was conducted; skills of identifying and expressing emotions to avoid excessive suppression or intensification of emotions were taught; patients’ overly negative interpretations of setbacks or failures were corrected through cognitive restructuring. ⑦ Stress response: Patients were helped to improve their ability to cope with stressors and difficulties in daily life. For example, they were taught to develop problem-solving skills (e.g. breaking down and prioritising problems); coping strategies and emergency plans were made to help patients remain calm in high-pressure environments; training in social skills (e.g. interacting with others and asking for help) was provided. ⑧ Cognitive reconstruction: Patients were helped to change negative thinking patterns and enhance self-efficacy, such as identifying their negative automated thoughts (such as ‘I have no value’); patients were guided to correct these cognitive errors by showing the evidence about what proved oneself worthless; patients were assisted to replace negative thinking with positive and realistic beliefs. ⑨ Behavioural activation: Patients were guided to improve their passive or isolated living conditions and become more enthusiastic about life. For example, patients were encouraged to participate in meaningful activities (such as practising hobbies and volunteer services); specific and achievable small goals were set to increase patients’ sense of accomplishment; a daily schedule was established to increase the regularity and efficiency of activities. ❿ Social functional training: The patient’s social interaction ability and social adaptation ability were improved by such training as conducting scenario simulation training and teaching basic communication skills (such as how to start and end conversations); patients were guided to practice skills in handling interpersonal conflicts in a safe environment; simulation training of work scenarios was offered to help patients gradually adapt to employment. ⑪ Family interventions: Family members’ ability was enhanced to support patients and reduce the risk of relapse, such as teaching family members the skills of effective communication and emotional expression, and reducing conflicts; disease education was supplied to help family members understand patients’ symptoms and behaviours; a family support plan was put forward to assist patients in establishing a stable, safe living environment. ⑫ Relapse prevention and long-term planning: The risk of relapse was reduced. The patient’s long-term recovery was supported by teaching both the patient and his or her family to develop a relapse response plan (such as how to deal with early signs); regular return visits were paid to evaluate the patient’s psychological state and social function; patients were encouraged to participate in community rehabilitation programmes or support groups to maintain therapeutic outcomes. Each treatment session lasted 60 min, with a frequency of 1 session per week. This treatment with CBT lasted for 3 months. The usage and dosage of aripiprazole were the same as above. During the intervention period, the team members remained unchanged, and all patients successfully completed the treatment with no dropouts.

Observation indicators

1. (1) Brief Psychiatric Rating Scale (BPRS): Before and after treatment in the two groups, the BPRS was used to assess the symptom severity of patients. This scale generally consisted of five symptom factors, namely, anxiety and depression (4 questions), lack of vigour (4 questions), thought disorder (4 questions), activation (3 questions), and hostility and suspiciousness (3 questions), with a score of 1–7 points for each query, and a total of 18–126 points. It stipulated that the higher total score means being associated with the worse the symptom (Morlan & Tan, Reference Morlan and Tan1998).

2. (2) Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): Before and after treatment in the two groups, the RBANS was adopted to evaluate the cognitive function of patients. This scale generally included five cognitive dimensions, namely immediate memory, Visual-spatial competence, language, attention, and delayed memory. The scores of each dimension were converted from the original scores to the standardised scores, with a mean of 100 points and a standard deviation of 15 points. The higher the total score, the better the cognitive function (Novitski et al., Reference Novitski, Steele, Karantzoulis and Randolph2012).

3. (3) Positive and Negative Syndrome Scale (PANSS): Before and after treatment in the two groups, PANSS was utilised to assess the mental state of patients. This scale generally included three sub-scales, namely, negative symptoms (7 questions), positive symptoms (7 questions), and general pathological symptoms (16 questions). Each question was scored 1–7 points, totalling 30–210 points. The higher the total score, the worse the mental state (Kay et al., Reference Kay, Fiszbein and Opler1987).

4. (4) Generalised Self-Efficacy Scale (GSES): Before and after treatment in both groups, the GSES was used to assess the psychological state of patients. This scale included 10 questions, each with a score of 1–4 points and a total score of 10–40 points. The higher the total score, the better the psychological state (Luszczynska et al., Reference Luszczynska, Scholz and Schwarzer2005).

5. (5) Generic Quality of Life Inventory 74 (GQOLI-74): Before and after treatment in the two groups, the GQOLI-74 was implemented to assess the quality of life of patients. This scale generally included four dimensions: material life, physical function, psychological function, and social relationship. The total score of each dimension was 0 ∼ 100 points. The higher the total score, the better the quality of life (Hou et al., Reference Hou, Xu, Dai and Yang2021).

6. (6) Efficacy: After treatment, the clinical efficacy of the two groups of patients was evaluated by the reduction rate of score reduction of the PANSS (Kay et al., Reference Kay, Fiszbein and Opler1987). A reduction rate of ≥50% denoted significant improvement, and a reduction rate of 25∼49% indicated partial improvement, while a reduction rate <25% suggested no improvement. The reduction rate was calculated as (total score before treatment – total score after treatment)/total score before treatment × 100%, and the overall improvement rate was determined as (number of cases showing significant improvement + number of cases showing partial improvement)/total number of cases × 100%.

7. (7) Complications: Statistical analysis of complications was made during treatment in the two groups, including those common complications related to the central nervous system, gastrointestinal tract, endocrine and metabolic systems, extrapyramidal symptoms, and cardiovascular system.

Statistical methods

Statistical analysis was carried out by SPSS 26.0 (Loffing, Reference Loffing2022). Qualitative data were described by [n (%)] for χ ² tests. Normally distributed quantitative data were described by $\overline{x}$ ± s for independent sample or paired t tests, and skewed quantitative data were described by M(p25, p75) for Mann–Whitney U tests. When a difference equalling P < 0.05 occurred, it was considered statistically significant.