Effectiveness the Information Motivation Behavioral model intervention on risky sexual behaviour among patients with Severe Mental Illness: A randomized controlled trial

Participants were randomized in a 1:1 ratio to either the Information-Motivation-Behavioral Skills (IMB) intervention or Mental Health Education (MHE). The IMB group received six comprehensive sessions, each lasting 2-3 hours, facilitated by gender-matched mental health workers. These sessions included activities like educational videos, discussions on HIV/STIs, and practical demonstrations on condom usage. The MHE group received standard mental health education.
Participants were randomized to one of two interventions:
Information-Motivation-Behavioral Skills (IMB) Intervention: This group received six comprehensive sessions, each lasting 2-3 hours, facilitated by gender-matched mental health workers. The sessions included activities such as educational videos, discussions on HIV/STIs, and practical demonstrations on condom usage.
Mental Health Education (MHE) Intervention: This group received standard mental health education.
Participants
Participants were adults aged 18 and above, diagnosed with both risky sexual behavior (RSB, a score of ≥1 on the RSB scale) and severe mental illness (SMI) confirmed using the MINI 7.0. Participants were required to be established residents of the study area, attending the outpatient department (OPD) and stable on medication, conversant in English or Luganda, and able and willing to be home visited. Exclusion criteria included severe cognitive or sensory impairments (e.g., deafness, muteness, blindness), inability to give written informed consent, previous treatment for RSB, and alcohol abuse problems as assessed by the CAGE.
Outcomes
Primary outcomes included changes in Information, Motivation, and Behavior (IMB) scores, measured using a 69-item checklist. Secondary outcomes included the rate of remission from RSB at a 3-month follow-up. There were no changes to the trial outcomes after commencement.
Sample Size
The trial sample size was 213, calculated using Cochran's formula with adjustments for continuous outcomes, anticipated dropout rate, and clustering. Initially planned for 116 participants, the study expanded to 221 to enhance robustness using the design effect. The trial included criteria for potential cessation, including undue risk or adverse effects, significant negative impact on the control arm, and ineffectiveness of the IMB intervention. However, the trial proceeded without interruptions as none of these conditions were met.
Randomization
The study team generated a computer-based random allocation sequence. Participants were then randomized in a 1:1 ratio to either the IMB or MHE intervention groups. Allocation concealment was maintained by having participants select paper balls marked "I" or "C" from a container, with separate selections for male and female participants to ensure gender balance. The selection process was further refined by subdividing participants into smaller groups. This process ensured that the intervention assignment was concealed until the moment of selection, preserving the integrity of the randomization. Research assistants conducting baseline and follow-up assessments were blinded to the intervention assignments to prevent bias in outcome assessment.
Allocation Concealment Mechanism
The random allocation sequence was implemented through participant-driven selection from a container, ensuring concealment until intervention assignment. Participants selected paper balls marked "I" for IMB or "C" for MHE from a container. This procedure was carried out separately for male and female participants to ensure gender balance and further refined by subdividing them into smaller groups for optimal group dynamics.


Blinding
Research assistants and participants conducting assessments at baseline and follow-up were blinded to the participants' assigned intervention groups.

Study setting and context
This study was undertaken among SMI attending OPD care at Butabika and Masaka hospitals. The provision of sexual and reproductive services in these mental health facilities was not emphasized in the routine health education sessions held at the facilities and these services were not readily available to individuals with mental health disorders generally.
Trial design
The trial involved 116 individuals, 58 at Butabika (29will be in the control arm and 29 in the intervention arm) and 58 (29 in the control arm and 29 in the intervention arm) at Masaka hospitals. Systematic random sampling was done. Each was randomised in a 1:1 ratio to either the control arm (to received health education as usual) or the intervention arm (to received IMB modules). Every odd number was assigned to the intervention and the even numbers to the control until the required sample size was obtained. If a participant dropped out of the study for example due to death, loss to follow up, or loses interest in continuing with the study. There was no replacement made. In both arms, trained psychiatric clinical officers/ nurses and the principal investigator screened SMI/RSB that attended the study OPD for eligibility. A minimum of 7 and a maximum of 14 eligible SMI with RSB study participants were enrolled per participating health facility per day. Enrolled participants were interviewed by principal investigator and the trained research workers (psychiatric clinical officers and nurses) with validated measures that assessed RSB and were in position to conduct the IMB modules at baseline and at 3 months.
Inclusion criteria
(vii) Aged 18 years and over
(viii) SMI with the evidence of a hospital record and confirmed using the MINI 7.0.2
(ix) An established resident of the study area
(x) Attendedthe OPD and stable on medication.
(xi) Conversant in English or Luganda (the predominant language spoken in the study areas)
(xii) Screened positive for RSB (a score of ≥1 on the RSB scale)
(xiii) Able and willing to be home visited

Exclusion criteria
(iv) Having severe cognitive or sensory impairments (i.e., is deaf, dumb, blind) which hindered engagement with the research procedures
(v) Unable to give written informed consent to participate in the trial
(vi) Already receiving treatment for RSB before the trial
(vii) Had an alcohol abuse problem (as assessed by the CAGE)

Study outcomes measures
The co-primary outcome measures:
i) Risky sexual behaviour (RSB) scores (assessed using the IMB scale) at 3 months a questionnaire assessing the three constructs (Information, motivation and behaviour) of individuals with RSB was administered as well The RSB scale has previously been validated in the HIV care situation of Uganda.
ii) Proportion of participants who failed to achieve remission from RSB (proportion on the IMB with high or the same scores) at 3 months
The secondary outcome measures;
i) Mean RSB scores (assessed using the IMB) at 3 months
ii) Proportion of participants who failed to achieve remission from RSB (proportion with IMB high or same scores) using the IMB questionnaire at 3 months
3.2.6 Randomisation and allocation
The 2 health care facilities were systematically randomised on a 1:1 ratio using a computer-generated list of codes and assignment.

 

Screening for study participants
A health talk about RSB was given by the PI and research assistants to individuals with SMI sitting in the triage area of the participating study sites. Using the generated numbers, the research assistants wereselectesd each participant accordingly, the odd numbers were in the intervention and the even number in the control arm (a total of 7-14 with RSB per day) and then invite them to participate in the study. The selected individuals with SMI were given details about the study objective, what would be expected of them if they enrolled in the study and. Those who has a positive score of 1 and above (From study I) were invited to undergo further evaluation by the PI and research assistants for study eligibility criteria.
Treatment allocation
The Usual Care
The government of Uganda adopted the WHO Mental Health Gap Action Programme (mhGAP) as the standard for mental health care in primary care facilities. However, the implementation of these guidelines is still a challenge in many African countries including Uganda. The research assistants in this arm were trained and supported to deliver the mhGAP Programme to SMI/ RSB study participants. The Usual Care arm therefore comprised of provision of screening results and health education which comprised of the different mental disorders, the medications, their side effects and the need to keep clinic appointments.
The IMB Intervention
The design of the IMB intervention above was guided by three principles: i) the intervention addressed the health system challenges in mental health care in Uganda and based on best global practices (hence the selection of the IMB intervention ii) the selected. The overall goal of the intervention was recovery from RSB as defined by being symptom free for at least one assessment at least two months apart. This was guided by two rules: the allocation to the different arms based on decision rules defined by severity of symptoms and response; and planned reviews of response at regular intervals (monthly for 3 months).
The IMB intervention was delivered by the PI and the research assistants. The intervention was coordinated by the PI.
The IMB intervention (Figure) will involved 3 steps:
Step 1 (Initiation of intervention): Patients with RSB-12 scores of 1-12 were advised about their scores, were given a pre-test assessment to establish where their knowledge gaps are and offered Psychoeducation (IMB modules). 10 sessions conducted (Undertaken by PI)
Step 2: Assessed at 3 months we did a post-test evaluatde whether the knowledge gaps had been addressed by the PI using the IMB questionnaire.
Step 3: (Referral to Mental Health Specialist/ Clinician in charge of facility): Those who required further help were referred to the specialists on duty. Treatment monitoring
Particpants were followed up after three Months to monitor IMB scores.


Treatment discharge
Discharge from treatment was considered at the end of the 3 months follow up. If a participant was lost to follow up, they were not replaced.
Reporting serious adverse events (SAEs)
There were no Serious adverse events (SAEs) by definition result in death, hospitalisation or significant disability and are therefore particularly important to report during a clinical trial because of their potential impacts on patient safety. SAEs would have been reported as soon as possible and within 72 hours of the knowledge of the event in accordance with the recommended Standard Operating Procedures of the Uganda National council of science and technology.
Sample size and power considerations
Sample size calculation:
n= (Z α/2+Z β) 2 2 Ṗ¯q¯
(P1-P2)2
α= 0.005
Z α/2 = 1.96
Β=0.2 (power), 80% Z β= .84
Ṗ¯= P1-P2
2
q¯= 1- Ṗ¯
d= p1-p2
Using our initial prevalence value of 45.7%, P1= 0.2865 in both the intervention and control arm at baseline and we assumed that after 3 months, the prevalence in the intervention would be 41.1% and in the control it remained 45.7%, assumeda 10% reduction in RSB at 3 months based on studies (Swarni et al 2017, Ybarra et al 2015, Chang et al 2014).
n= (1.96+.84)2 2(0.345x0.655) = 1.4970392
(0.23)2 0.0529
= 28.3
N= 2xn= 56.6
Adjustments
Assumed a dropout rate of R0= 20% and a drop-in rate of R1= 2%
The adjusted sample size will be 56.6 = 56.6 = 56.6 = 93
(1-0.20-0.02)2 (0.78)2 0.6084

Step 2: N adjusted = 93 = 116 (Final sample size)
1-NR 0.8
Design effect
It is the ratio of variance of the estimate under multistage sampling method to simple random sampling. Usually design effect lies between 2 to 4(Penh et al, 2011, WHO 2015). In the World Health Organization Vaccination Coverage Cluster Surveys: Reference Manual" version 3, we estimated it from previous surveys and the recommended cluster size was between 400-1000 individuals), so the expected RSB prevalence was best guess, πg = 364 per 100,000, variation is k=0.5 and we chose m= 550
The formula is DEEF= 1+ (m-1) k2 πg
1-πg

k=0.5, m=550, πg= 0.00364

DEEF = 1-(550-1) x0.52x0.00364
1-0.00364

DEEF= 1.501, rounded up, to give 2, this meant our final sample size was 119x2=238.
Mode of analysis
We adjusted for loss to follow up and for cross over
There was no cross over; dropouts (a proportion of those randomized to intervention who will refuse or will not take up the intervention, R0) as well as drop in s (a proportion of those randomized to control that may end up getting the intervention, R1).

1. We used intention to analysis where everyone was analysed in the arm that they will be randomized.
2. We assessed for the effect of randomization by comparing the two groups with regard to baseline characteristics. the variables which will not be balancing (accidental bias), these will be adjusted for in the final model.
3. Final conclusions were made on the difference in proportions of IMB at the end of the study between the two groups and not the difference of differences. This wa because the follow up period was short and it wasunlikely that the behavior would change within 3 months

2020-01-13

2020-01-14

Reduction in risky sexual behaviour

Primary outcomes included changes in Information, Motivation, and Behavior (IMB) scores, measured using a 69-item checklist

Secondary outcomes included the rate of remission from RSB at a 3-month follow-up. There were no changes to the trial outcomes after commencement.

Secondary outcomes included the rate of remission from RSB at a 3-month follow-up. There were no changes to the trial outcomes after commencement.

Between January 13, 2020, and April 30, 2020, we conducted a parallel randomized controlled clinical trial at Butabika National Referral Hospital and Masaka Regional Referral Hospital. Patients were randomized 1:1 to either the intervention or control arm. The intervention group comprised 117 participants, while the control group included 104 participants. These hospitals were purposively selected due to their focus on mental health patients and the observed deficiency in addressing sexual and reproductive health services within routine health education sessions for individuals with mental health disorders.
Interventions
Participants were randomized to one of two interventions:
Information-Motivation-Behavioral Skills (IMB) Intervention: This group received six comprehensive sessions, each lasting 2-3 hours, facilitated by gender-matched mental health workers. The sessions included activities such as educational videos, discussions on HIV/STIs, and practical demonstrations on condom usage.
Mental Health Education (MHE) Intervention: This group received standard mental health education.
Participants
Participants were adults aged 18 and above, diagnosed with both risky sexual behavior (RSB, a score of ≥1 on the RSB scale) and severe mental illness (SMI) confirmed using the MINI 7.0. Participants were required to be established residents of the study area, attending the outpatient department (OPD) and stable on medication, conversant in English or Luganda, and able and willing to be home visited. Exclusion criteria included severe cognitive or sensory impairments (e.g., deafness, muteness, blindness), inability to give written informed consent, previous treatment for RSB, and alcohol abuse problems as assessed by the CAGE.

Sample Size
The trial sample size was 213, calculated using Cochran's formula with adjustments for continuous outcomes, anticipated dropout rate, and clustering. Initially planned for 116 participants, the study expanded to 221 to enhance robustness using the design effect. The trial included criteria for potential cessation, including undue risk or adverse effects, significant negative impact on the control arm, and ineffectiveness of the IMB intervention. However, the trial proceeded without interruptions as none of these conditions were met.
Randomization
The study team generated a computer-based random allocation sequence. Participants were then randomized in a 1:1 ratio to either the IMB or MHE intervention groups. Allocation concealment was maintained by having participants select paper balls marked "I" or "C" from a container, with separate selections for male and female participants to ensure gender balance. The selection process was further refined by subdividing participants into smaller groups. This process ensured that the intervention assignment was concealed until the moment of selection, preserving the integrity of the randomization. Research assistants conducting baseline and follow-up assessments were blinded to the intervention assignments to prevent bias in outcome assessment.
Allocation Concealment Mechanism
The random allocation sequence was implemented through participant-driven selection from a container, ensuring concealment until intervention assignment. Participants selected paper balls marked "I" for IMB or "C" for MHE from a container. This procedure was carried out separately for male and female participants to ensure gender balance and further refined by subdividing them into smaller groups for optimal group dynamics.


Blinding
Research assistants conducting assessments at baseline and follow-up were blinded to the participants' assigned intervention groups.
Data collection and management
A parallel randomized controlled clinical trial was conducted at Butabika and Masaka hospitals from January 13th to 24th, 2020. The study utilized a mixed-methods approach for data collection and management, encompassing both quantitative and qualitative elements. It involved adult outpatients diagnosed with both Risky Sexual Behavior (RSB) and Severe Mental Illness (SMI) who were systematically randomized into either the Information-Motivation-Behavioral Skills (IMB) intervention group or the Mental Health Education (MHE) control group. Allocation concealment was ensured through a participant-driven selection process, and research assistants were blinded to group assignments. The IMB group received six comprehensive sessions incorporating educational videos, discussions, and demonstrations, while the MHE group received standard mental health education. Participants were followed up three months later from April 15th to 30th, 2020. Participants were subjected to a comprehensive 69-item reproductive health checklist, encompassing information, behavior, and motivation constructs, was administered to assess participants' reproductive health knowledge, attitudes, and practices. Data collection involved interviewer-administered face-to-face paper questionnaires, which were stored securely and reviewed for completeness and accuracy. A study database was designed in OpenClinica, with unique identifiers for each participant. Data underwent double entry and regular quality checks, with any discrepancies resolved promptly. Once validated, the data was exported to Stata for statistical analysis. The master database was maintained on a secure server with password-protected copies accessible to authorized personnel. A detailed data dictionary was prepared to facilitate data curation.
Data analysis
Data were summarized using descriptive statistics, including frequencies and proportions for categorical variables, and means and standard deviations for continuous variables. The primary analysis employed intention-to-treat (ITT) principles, utilizing random effects linear regression models to evaluate the intervention's effect on the continuous outcome variable while adjusting for baseline imbalances. Subgroup and sensitivity analyses were conducted to assess the robustness of the findings and explore potential effect modifiers.
The analysis accounted for potential biases, such as attrition and missing data, and explicitly stated model assumptions and limitations. All statistical analyses were performed using Stata version 17, with detailed documentation of syntax and commands to ensure reproducibility.

The study team generated a computer-based random allocation sequence. Participants were then randomized in a 1:1 ratio to either the IMB or MHE intervention groups. Allocation concealment was maintained by having participants select paper balls marked "I" or "C" from a container, with separate selections for male and female participants to ensure gender balance. The selection process was further refined by subdividing participants into smaller groups. This process ensured that the intervention assignment was concealed until the moment of selection, preserving the integrity of the randomization. Research assistants conducting baseline and follow-up assessments were blinded to the intervention assignments to prevent bias in outcome assessment.

The randomization unit in this study is the individual participant. Participants were randomized in a 1:1 ratio to either the IMB (Information-Motivation-Behavioral Skills Model) or MHE (Mental Health Education) intervention groups. The process of having participants individually select paper balls from a container indicates that randomization occurred at the individual level, with efforts to ensure gender balance and maintain allocation concealment.

No

The trial sample size was 213, calculated using Cochran's formula with adjustments for continuous outcomes, anticipated dropout rate, and clustering. Initially planned for 116 participants, the study expanded to 221 to enhance robustness using the design effect. The trial included criteria for potential cessation, including undue risk or adverse effects, significant negative impact on the control arm, and ineffectiveness of the IMB intervention. However, the trial proceeded without interruptions as none of these conditions were met.

The planned number of observations in the trial was originally 116 participants, as stated. However, this was later expanded to 221 participants to enhance the study's robustness, considering factors like dropout rate and clustering using the design effect. So, while the planned number of observations was 116, the actual number of observations became 221 participants, allowing for more comprehensive data collection and analysis.

The randomized clinical trial included 213 participants, with 100 in the control group and 113 in the intervention group. Participant flow was as follows: initially, 221 individuals were assessed for eligibility, out of which 213 were randomized in a 1:1 ratio into either the control arm (receiving standard health education) or the intervention arm (receiving IMB modules). The trial employed systematic random sampling, and participants were not replaced if they dropped out for various reasons. The intervention phase involved six comprehensive sessions, each lasting approximately 2-3 hours, tailored to address self-management, coping with stigma, and enhancing assertiveness and communication skills. In the control arm, 4 participants were lost to follow-up, (I, was nursing a sick relative away from home, 2 had traveled to visit relatives, 1 the phone number was off and directions to home were not clear) and similarly, 4 in the intervention arm were lost to follow up (2 their phone numbers were off, directions were not clear, 2 had traveled away from home.

The calculated power of the study is approximately 95.21%. This indicates a strong likelihood that the study would detect a true effect, if one exists, given the sample sizes and the assumed effect size