1. Identify the specific sampling method used for the study (i.e. bringing subjects into the study). Discuss how well this sampling method produces a sample representative of the population.

1. Identify and evaluate the inclusion and exclusion criteria used in the study. Describe any missing criteria that you believe should be there.

1. Discuss how the planned sample size was determined (including power analysis & consideration of potential attrition if included).

1. Discuss actual sample size attained for the study, including acceptance rate or refusal rate, and attrition rate if provided, or if you calculated them.

1. Describe the study setting [hospital, clinic, home, or other] and its appropriateness for the study.Study setting

The study was conducted at the Main University Hospi- tal's psychiatric outpatient clinics affiliated with Alexan- dria University's Faculty of Medicine. The clinics offer free treatment to clients with mental diseases. These treatments include mental health evaluation and diag- nosis, pharmaceutical prescriptions, and counseling. The intervention took place in the outpatient clinic, which was equipped with various rooms to accommodate the different needs of the patients. The researchers chose a rehabilitation room with a quiet, welcoming, comfort- able environment and a private and confidential space to demonstrate client therapy sessions. The clinics are open three days a week (Sunday, Monday, and Tuesday) for cli- ents with mental illnesses from 8 a.m. to 2 p.m.

Participants: sample size calculation and sampling technique The number of clients with bipolar disorders who regu- larly visit psychiatric outpatient clinics ranges from one to four every day (216 to 864 clients/6 months), accord- ing to hospital statistics for 2021-2022. The sample size was determined using the G*Power Windows 3.1.9.7 pro- gram, with the following criteria: effect size=0.25, err prob=0.05, power (1-err prob)=0.85, number of groups examined=2, and the number of measurements=3, fol- lowing Sim, and Lewis (2012) [20]. Thus, the study group contained 30 clients with a DSM-5 bipolar diagnosis, and the control group had a similar number.

Inclusion criteria

Specific eligibility criteria were established to ensure par- ticipants' suitability for the study. These criteria included the requirement that clients must be at least 18 years old, able to communicate coherently and meaningfully, pos- sess reading and writing abilities, and not have an ill- ness that has persisted for over 10 years. Their medical records were retrieved and reviewed to confirm the cli- ent's eligibility. Outpatients who met the criteria for type I or II bipolar disorder as outlined in the Diagnostic and

Statistical Manual for Mental Disorders, Fifth Edition (DSM-V) were selected as subjects for the study through a random selection process [4].

Exclusion criteria

To ensure that bipolar disorders were not influenced by comorbid conditions, clients who exhibited chronic psy- chotic symptoms, were diagnosed with psychotic comor- bidity, or were found under the influence of drugs or alcohol were excluded from participation in this study. The eligibility of potential participants was confirmed through a combination of direct questioning and review- ing their medical records.

Random allocation

Using Research Randomizer version 4.0, eligible clients with BD were given ACT therapy at a 1:1 ratio chosen randomly. A software application generated random integers with a predefined group code. After getting written consent from eligible participants, a structured interview to investigate each client's mood symptoms was conducted; the enrolling investigators asked the clients to choose a number between 1 and 60 to deter- mine their group assignment. The trained researcher who prepared the software program and the enrolling inves- tigators were not involved in any other trial operations; therefore, the allocation was kept secret. Throughout the trial, trained outcome assessors were blinded to group assignments. The ACT intervention will consist of eight sessions delivered over eight weeks, with evaluations of outcomes at baseline, study completion, and two-month follow-up.

The flow chart for BD (Fig. 1) shows that participants (n=30) got acceptance and commitment therapy (ACT) face-to-face for 8 weeks. The immediate post-treatment assessments were performed with all BD clients in the intervention and control groups (n=60). All participants completed the two-month follow-up posttest (30 from the intervention group and 30 from the control group).

Tools for data collection

The data for the current study was gathered using the fol- lowing tools:

Tool I: sociodemographic and clinical data, structured interview schedule The researchers developed this tool to elicit data from clients' sociodemographic characteristics, such as age and marital status. It was also used to collect information about the person's level of education, the length of their first psychiatric visit, the length of their illness, the causes of previous episodes, and the medicines they were given.Tool II: acceptance and action questionnaire-ii (AAQII)

AAQII consists of seven items on a Likert-type self- report scale to measure psychological flexibility [21]. Defusion, acceptance, and commitment to action are fundamental processes. Following each item is a Likert scale with the options never true [1] to always true [7]. Greater psychological inflexibility is indicated by higher scores, which fall within the 7-49 total score range, determined from the sum of the item responses. Cron- bach's alpha was 0.93, according to earlier studies [22]. The scale we employed had a standard Arabic translation, and Cronbach's alpha was 0.81, indicating good internal consistency.

Tool III: the short Arabic version of the UPPS-P impulsivity behaviour scale SUPPS-P consists of 20 items, initially developed by Whiteside & Lynam (2001) [23], to assess five aspects of impulsivity: Positive Urgency, Negative Urgency, Lack of Perseverance, Lack of Premeditation, and Sensation- Seeking. Every one of the five aspects is evaluated using a 4-point Likert scale. The Arabic version of SUPPS-P was first back-translated into Arabic by the writers Bteich, Berbiche, and Khazaal (2017) [24] after being profession- ally translated from French into Arabic. Based on Cron- bach's coefficients, the results showed that the scale was reliable, ranging from 0.58 to 0.81. Moreover, the authors use confirmatory factor analysis (CFA) to examine the covariance matrix. S-UPPS-P subscales showed statis- tically significant associations. Moreover, variations in the significance of the correlations ranged from.18 to.29, showing that the Arab short UPPS-P is a reliable evalu- ation tool with strong psychometric properties. In our study, the scale showed good internal consistency with = 0.80.

Tool IV: the Arabic versions of the Beck scale for suicide ideation (BSSI) Beck et al. (1979) developed the BSSI, a 19-item scale that measures how strong suicidal thoughts were the week before the test [25]. Beck et al. (1988) introduced the self- reporting edition of the measure. Each item is rated on an ordinal scale of 0 to 2; the total score ranges from 0

Table 1 Time Plan of the Session

to 38 [26]. Individuals respond to the first five things that are excerpted. If an individual replies positively to the fifth item (scores 1 and 2), he or she answers the remain- ing items; otherwise, the questionnaire is finished.As a result, for data analysis, we used overall scale scores. With a Cronbach's alpha range between 0.89 and 0.94 and a test-retest coefficient of 0.79, we used the study of Alsalman & Alansari (2019) to demonstrate satisfactory reliability [27]. Also, the internal consistency of the scale in this study reveals its reliability with = 0.82.

Procedure

Ethics approval and consent to participate

The Ethical Committee of Alexandria University's Faculty of Nursing reviewed and accepted the study proposal. An agreement from the head of the psychiatric outpa- tient clinics at the Main Alexandria University Hospital for Psychiatric Medicine and the Patients' Rights Protec- tion Committee of the Ministry of Health and Popula- tion's General Secretariat of Mental Health in Cairo was obtained to conduct the trial. Following an explanation of the therapy's aims, each client participating in the ther- apy provided informed written permission. It was pro- tected by keeping the client's identity and personal data confidential. The client's right to decline or withdraw from the research at any moment was underlined.

Preparation: A structured interview took 10 to 15 min to collect the baseline assessment data using the study scales SUPPS-P and BSSI.

Pilot study: In this study, five clients with BD were chosen randomly to determine clarity and any barriers encountered during data collection; those individuals were eliminated from the main study. The instruments were clear, intelligible, and valuable in the pilot study. The Alpha Cronbach's test was used to determine the internal consistency of the study instrument.

Intervention phase: The ACT intervention consists of five groups, each with six clients [28, 29]. The ACT ses- sions were 90 min long and held weekly for eight weeks. During ACT, all clients continued their usual care (TAU), including receiving one or more mood stabilizers pre- scribed by their usual psychiatrist, expert care coordina- tion, and emotional support. ACT therapy group sessions were face-to-face with two certified ACT psychiatric nurse researchers for five consecutive groups to design a framework for each session and, at the same time, work through exercises in response to the direct experiences of each group. The sessions comprised two psychoeduca- tional sessions and six skill-training sessions in which cli- ents acquired skills (see Table 1 for the session time plan).

Phase I consisted of two sessions, with the first focus- ing on the ACT session's general goals and expectations of participants. The second session concentrated on psychoeducation; topics concerning drugs, symptoms,

Session time plan (90 min)

5 min: practicing mindfulness, examining the self and the external world. 15 min: Review previous concepts and challenges encountered by BD clients during skill demonstration. 30 min: The trained researcher will apply and dem- onstrate the session's new concepts through videos.

30 min: Discussed the session's objective and skills with the clients and asked them to demonstrate the strategies they learned throughout the session. 10 min: homework assignments.

El-Sayed et al. BMC Nursing (2023) 22:271

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and the history of the illness were thoroughly addressed to equip clients with the essential information required to comprehend BD. Based on a treatment manual and applications of ACT developed by Hayes et al. (1999), Bach & Hayes (2002), Bloy, Oliver, & Morris (2011), El- Ashry et al. (2021) [16, 30-32] on clients with psychosis, and O'Donoghue et al. (2018) on clients with BD, the researchers created a psychoeducational module of the ACT strategy [28].

In Phase II, clients attended six skill-training sessions to learn ACT and therapy skills. After cultural adaptation to the Egyptian context, a structured manual was given to the clients. So, each session's main aims and materials were translated into Arabic. Accordingly, each ACT ses- sion's general and specific goals were established. Accord- ing to the ACT approach, the goal of the intervention was to help the person become more psychologically flexible (have a more accepting, thoughtful, and calm response to BD symptoms and related emotions and thoughts) so that they could act in line with their values. The ACT intervention emphasizes psychoeducational methods for bipolar and mood disorders. Each session focuses on a unique aspect of bipolar disorders, such as mania, stress, impulsivity, sadness, medication, talking with loved ones, and suicide. Each session presents ACT techniques as an alternative response to bipolar disorder symptoms. The ACT groups are meant to be collaborative, involv- ing experiential activities throughout, a commitment to working towards a valued goal, and mindfulness exercises between sessions.

The intervention's exercises (such as brief mindful- ness, defusion, and value clarification) highlight how participants may accidentally become "caught up" in struggling with their BD symptoms and distress and thus adopt maladaptive coping strategies such as impulsiv- ity and suicide. Activities were brief, and learning points were timed and structured to meet challenges. Particular emphasis was placed on encouraging practice at home. A prepared film of an actor portraying a man expressing obstacles in his life was used to demonstrate the meta- phor's real-world relevance and broad applicability. We recognize that eight weeks is a relatively brief period for evaluating change. This period is adequate for the practi- cal aims of this study, as we are more concerned with the possible usefulness of the intervention than with its last- ing consequences (see Table 2).

The posttest phase was performed twice immediately following the end of all sessions and a two-month follow- up using S-UPPS-P and BSSI.

The control group

As a control group, clients were randomly assigned to their respective groups and continued to receive their usual care (TAU), which included receiving one or more

mood stabilizers and antipsychotics as recommended by their psychiatrist from the outpatient clinic. Assessments and evaluations were conducted concurrently with the intervention group on the screening day and two months later at the end of the study. It was worth mentioning that the control group was on a waiting list, as they received the same intervention as the study group after the trial finished. The researchers contacted the clients through their phones and What's Up groups.

Data processing and analysis

Data were put into the computer, and the IBM SPSS soft- ware package, version 23.0, was used to analyze the data. To compare two categories of normally distributed quan- titative variables, the Student t-test was used. ANOVA with repeated measures followed by Bonferroni adjust- ment for multiple comparisons between the three periods in each group. The Shapiro-Wilk test was used to verify the variable distribution's normality. The Chi-square test is used when categorical variables are compared between groups (Monte Carlo or Fisher Exact). A 5% level of sig- nificance was applied to the obtained results.

Results

The study found that most clients in the intervention group (56.7%) and the control group (40%) were between 30 and 39. Over half of the clients in both groups (63.3% in the intervention group and 56.7% in the control group) held a university degree. Single clients accounted for 56.7% of the intervention group and 46.7% of the control group. More than half of the clients in both groups had families with 2 to 4 members (53%). Additionally, most clients in both groups (63.3% in the intervention group and 53.3% in the control group) considered their income sufficient (Table 3).

In the intervention group, 36.7% of clients experienced bipolar disorder symptoms for less than a year, while only 20% were in the control group. More than half of the par- ticipants in both groups had been hospitalized one to five times (76.7% in the study group and 53.3% in the control group). Most clients in both groups reported no physical illnesses (70% in the intervention group and 60% in the control group). Treatment methods included ECT ses- sions for 30% of participants in both groups and phar- maceutical treatment for 70%. There were no significant differences in sociodemographic and clinical character- istics between the intervention and control groups, indi- cating they were well-matched (see Table 4).

The baseline mean score of the AAQ-II was 31.81 (SD=6.08) for the intervention group and 32.73 (SD=4.98) for the control group. After the intervention, the intervention group's mean AAQ-II score decreased significantly to 22.05 (SD=5.72), while the control group's mean score increased slightly to 33.43 (SD = 5.26).