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

Last registered on October 07, 2024

Pre-Trial

Trial Information

General Information

Title
Effectiveness the Information Motivation Behavioral model intervention on risky sexual behaviour among patients with Severe Mental Illness: A randomized controlled trial
RCT ID
AEARCTR-0013666
Initial registration date
September 27, 2024

Initial registration date is when the trial was registered.

It corresponds to when the registration was submitted to the Registry to be reviewed for publication.

First published
October 07, 2024, 7:07 PM EDT

First published corresponds to when the trial was first made public on the Registry after being reviewed.

Locations

Region

Primary Investigator

Affiliation
Medical reserach council, Entebbe

Other Primary Investigator(s)

Additional Trial Information

Status
Completed
Start date
2020-01-13
End date
2020-04-30
Secondary IDs
Prior work
This trial does not extend or rely on any prior RCTs.
Abstract
Trial Design and Methods: This randomized controlled trial in Uganda evaluated the Information Motivation Behavioral (IMB) model's impact on reducing risky sexual behavior (RSB) among 213 participants with severe mental illness (SMI). Participants were divided into two groups: one receiving standard health education (control group) and the other receiving IMB model interventions (intervention group).
Results: The trial showed no significant difference in information scores between the groups post-intervention. However, there was a notable increase in motivation scores in the intervention group, suggesting the potential effectiveness of the IMB model.
Conclusions: Integrating the IMB model into mental health care services could improve sexual health education and promote safer sexual behaviors among individuals with SMI. The study recommends healthcare workers to incorporate sexual health discussions in routine care and calls for further research on the IMB model's integration into mental health care.
External Link(s)

Registration Citation

Citation
Birungi, Caroline. 2024. "Effectiveness the Information Motivation Behavioral model intervention on risky sexual behaviour among patients with Severe Mental Illness: A randomized controlled trial." AEA RCT Registry. October 07. https://doi.org/10.1257/rct.13666-1.0
Experimental Details

Interventions

Intervention(s)
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.
Intervention Start Date
2020-01-13
Intervention End Date
2020-01-14

Primary Outcomes

Primary Outcomes (end points)
Reduction in risky sexual behaviour
Primary Outcomes (explanation)
Primary outcomes included changes in Information, Motivation, and Behavior (IMB) scores, measured using a 69-item checklist

Secondary Outcomes

Secondary Outcomes (end points)
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 (explanation)
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.

Experimental Design

Experimental Design
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.
Experimental Design Details
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.
Randomization Method
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.
Randomization Unit
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.
Was the treatment clustered?
No

Experiment Characteristics

Sample size: planned number of clusters
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.
Sample size: planned number of observations
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.
Sample size (or number of clusters) by treatment arms
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.
Minimum detectable effect size for main outcomes (accounting for sample design and clustering)
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
Supporting Documents and Materials

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IRB

Institutional Review Boards (IRBs)

IRB Name
IRB Approval Date
IRB Approval Number

Post-Trial

Post Trial Information

Study Withdrawal

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Intervention

Is the intervention completed?
Yes
Intervention Completion Date
April 30, 2020, 12:00 +00:00
Data Collection Complete
Yes
Data Collection Completion Date
April 30, 2020, 12:00 +00:00
Final Sample Size: Number of Clusters (Unit of Randomization)
213
Was attrition correlated with treatment status?
Yes
Final Sample Size: Total Number of Observations
213
Final Sample Size (or Number of Clusters) by Treatment Arms
At enrollment we had 117 in the intervention, 104 in the control arms, after 3 months, in the intervention we remained with 113 and 100 respectively
Data Publication

Data Publication

Is public data available?
No

Program Files

Program Files
Reports, Papers & Other Materials

Relevant Paper(s)

Reports & Other Materials