Discrimination, PerceivedNCT06909734
Trauma-Informed Motivational Interviewing in Rural Dwelling Samples
A study testing Trauma-Informed Motivational Interviewing in people with Discrimination, Perceived, run by Alexandria University at 1 site in Egypt.
Trial summary
Leprosy remains a profoundly stigmatized condition in many rural communities worldwide, fostering social exclusion, body image dissatisfaction, and diminished mental health outcomes. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Discrimination, Perceived
- What is being tested?
- Trauma-Informed Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2025to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals with a confirmed medical diagnosis of leprosy (current or past) experiencing physical, emotional, or social consequences.
Who cannot join
- Severe Cognitive or Psychiatric Impairments:
- Individuals with severe mental health conditions (e.g., untreated psychosis, severe intellectual disabilities) that impede the reflective, goal-setting nature of Motivational Interviewing.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Nursing
Alexandria, 21523
Rasha Eweida, 01286640701, rashapsych@alexu.edu.eg
About this study
Official title: Trauma-Informed Motivational Interviewing as a Frontrunner Paradigm for Addressing Leprosy-Related Discrimination, Body Image Dissatisfaction, Resilience, and Social Engagement in Rural Dwelling Samples
Leprosy remains a profoundly stigmatized condition in many rural communities worldwide, fostering social exclusion, body image dissatisfaction, and diminished mental health outcomes. TTrauma-Informed Motivational Interviewing (TIMI) emerges as a promising paradigm to address these psychosocial challenges, enhancing resilience, improving self-perception, and fostering social re-engagement.
Read the detailed description
Introduction
Leprosy remains a profoundly stigmatised condition in many rural communities worldwide, fostering social exclusion, body image dissatisfaction, and diminished mental health outcomes. Traditional biomedical approaches, while essential for physical recovery, often neglect the psychological and social ramifications of the disease. Trauma-Informed Motivational Interviewing (TIMI) emerges as a promising paradigm to address these psychosocial challenges, enhancing resilience, improving self-perception, and fostering social re-engagement.
Understanding the Psychological Impact of Leprosy
Leprosy-related stigma is multifaceted, rooted in cultural beliefs, misinformation, and visible physical impairments. Affected individuals frequently endure social rejection, which fosters feelings of shame, body image dissatisfaction, and emotional distress. These experiences, akin to trauma, may disrupt self-efficacy and hinder engagement with both healthcare systems and social networks.
Trauma-Informed Motivational Interviewing: Core Principles
TIMI integrates two evidence-based approaches: Trauma-Informed Care (TIC) and Motivational Interviewing (MI). TIC emphasises understanding and acknowledging the impact of trauma on individuals' behaviours and emotional well-being. MI, a client-centred approach, fosters intrinsic motivation for change by exploring ambivalence and strengthening personal autonomy.
The synergy of TIMI rests on five core principles:
Safety: Ensuring physical and emotional safety in all interactions.
Trustworthiness and Transparency: Building a collaborative, open relationship.
Peer Support and Empowerment: Encouraging individuals to harness personal and community strengths.
Collaboration and Mutuality: Shifting the power dynamic to promote shared decision-making.
Cultural, Historical, and Gender Awareness: Respecting cultural narratives and addressing systemic inequalities.
Addressing Key Psychosocial Challenges
Combatting Discrimination and Stigma: TIMI helps reframe self-perceptions, encouraging individuals to challenge internalised stigma and societal bias. By fostering empathy and understanding, community members may also engage in reducing discriminatory attitudes.
Improving Body Image and Self-Esteem: Acknowledging the emotional weight of physical changes, TIMI supports individuals in developing healthier self-concepts. Through guided dialogue, participants explore their strengths and redefine their value beyond appearance.
Building Resilience: TIMI fosters a growth mindset, promoting coping strategies that empower individuals to navigate adversity. This is crucial in rural settings where access to mental health services may be limited.
Enhancing Social Engagement: By empowering participants to explore their personal goals and values, TIMI helps identify pathways to meaningful social connections, promoting reintegration into community life.
Implementation in Rural Contexts
Adapting TIMI to rural environments necessitates a culturally sensitive approach. Training local healthcare providers, community leaders, and peer mentors in TIMI principles ensures sustainability. Additionally, integrating TIMI within existing community health frameworks, such as primary healthcare clinics or local support groups, facilitates accessibility.
- Conditions
- Discrimination, Perceived
- Being tested
- Trauma-Informed Motivational Interviewing
- Keywords
- Leprosy, Discrimination, Body Image, Resilience, Social
- Medical subject headings
- Perceived Discrimination, Leprosy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trauma-Informed Motivational InterviewingBehavioural
Trauma-Informed Motivational Interviewing: Core Principles
TIMI integrates two evidence-based approaches: Trauma-Informed Care (TIC) and Motivational Interviewing (MI). TIC emphasises understanding and acknowledging the impact of trauma on individuals' behaviours and emotional well-being. MI, a client-centred approach, fosters intrinsic motivation for change by exploring ambivalence and strengthening personal autonomy.
| Study group | Role | What they receive |
|---|---|---|
| interventional group | Experimental | This investigation will draw upon existing literature exploring the intersection of TIMI in Leprosy-Related Discrimination, Body Image Dissatisfaction, Resilience, and Social Engagement in Rural Dwelling Samples. By understanding how Threat to Identity and Meaning in Illness (TIMI) influences the psychological and social impact of leprosy-related discrimination. It explores how body image dissatisfaction affects self-perception and mental health while assessing resilience as a coping mechanism. Additionally, it examines social engagement in rural settings, where stigma may lead to isolation. The findings can inform targeted mental health interventions and stigma-reduction strategies to support affected individuals. Receives: Behavioral: Trauma-Informed Motivational Interviewing |
| control group | Placebo comparator | traditional standardized care such as Group Therapy/ peer support. Receives: Behavioral: Trauma-Informed Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leprosy-Related Discrimination
To assess the stigma surrounding leprosy, this scale comprises four domains: Experienced stigma, Disclosure concerns, Internalized stigma, and Anticipated stigma. Each domain aims to capture different facets of the stigma experienced by individuals affected by leprosy. With a total of 21 questions, the SARI Stigma Scale explores how patients encounter stigma in their daily lives. The scoring method used is that if the patient answers no, do not know, or it is not relevant, they will be given a score of zero, whereas if they answer yes, the patient will receive a score ranging from one to three depending on the frequency the patient experiences.
Measured: 1 month and half
Secondary outcomes (1)
Body Image Psychological Inflexibility Scale (BIPIS).
Body Image Psychological Inflexibility Scale (BIPIS). The BIPIS was developed by the Callaghan et al., (2015) and is the scale under investigation. The tool resulted in 16-item scale had high internal consistency (%0.93). Scores on the BIPIS are calculated by summing the total (item 9 is reverse scored); higher scores indicate greater psychological inflexibility. Each item is rated on a Likert-type scale ranging from 1 (never true) to 7 (always true). All BIPIS items are summed for a total, and higher scores are indicative of higher levels of psychological inflexibility in body image.
Measured: 1 month and half
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2025
- Study start1 Mar 2025
- Primary completion20 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discrimination, PerceivedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rasha salah elsayed eweida, Alexandria University
- Investigators
- rasha eweida, Principal investigator, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06909734
- Sponsor's protocol ID
- 2232025
- Status last verified
- Apr 2025
- First submitted
- 22 Mar 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trauma-Informed Motivational Interviewing as a Frontrunner Paradigm for Addressing Leprosy-Related Discrimination, Body Image Dissatisfaction, Resilience, and Social Engagement in Rural Dwelling Samples
- ClinicalTrials.gov ID
- NCT06909734
- Acronym / sponsor ID
- 2232025
- Conditions
- Discrimination, Perceived
- Keywords
- Leprosy, Discrimination, Body Image, Resilience, Social
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 20 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Leprosy remains a profoundly stigmatized condition in many rural communities worldwide, fostering social exclusion, body image dissatisfaction, and diminished mental health outcomes. TTrauma-Informed Motivational Interviewing (TIMI) emerges as a promising paradigm to address these psychosocial challenges, enhancing resilience, improving self-perception, and fostering social re-engagement.
Detailed description
Introduction
Leprosy remains a profoundly stigmatised condition in many rural communities worldwide, fostering social exclusion, body image dissatisfaction, and diminished mental health outcomes. Traditional biomedical approaches, while essential for physical recovery, often neglect the psychological and social ramifications of the disease. Trauma-Informed Motivational Interviewing (TIMI) emerges as a promising paradigm to address these psychosocial challenges, enhancing resilience, improving self-perception, and fostering social re-engagement.
Understanding the Psychological Impact of Leprosy
Leprosy-related stigma is multifaceted, rooted in cultural beliefs, misinformation, and visible physical impairments. Affected individuals frequently endure social rejection, which fosters feelings of shame, body image dissatisfaction, and emotional distress. These experiences, akin to trauma, may disrupt self-efficacy and hinder engagement with both healthcare systems and social networks.
Trauma-Informed Motivational Interviewing: Core Principles
TIMI integrates two evidence-based approaches: Trauma-Informed Care (TIC) and Motivational Interviewing (MI). TIC emphasises understanding and acknowledging the impact of trauma on individuals' behaviours and emotional well-being. MI, a client-centred approach, fosters intrinsic motivation for change by exploring ambivalence and strengthening personal autonomy.
The synergy of TIMI rests on five core principles:
Safety: Ensuring physical and emotional safety in all interactions.
Trustworthiness and Transparency: Building a collaborative, open relationship.
Peer Support and Empowerment: Encouraging individuals to harness personal and community strengths.
Collaboration and Mutuality: Shifting the power dynamic to promote shared decision-making.
Cultural, Historical, and Gender Awareness: Respecting cultural narratives and addressing systemic inequalities.
Addressing Key Psychosocial Challenges
Combatting Discrimination and Stigma: TIMI helps reframe self-perceptions, encouraging individuals to challenge internalised stigma and societal bias. By fostering empathy and understanding, community members may also engage in reducing discriminatory attitudes.
Improving Body Image and Self-Esteem: Acknowledging the emotional weight of physical changes, TIMI supports individuals in developing healthier self-concepts. Through guided dialogue, participants explore their strengths and redefine their value beyond appearance.
Building Resilience: TIMI fosters a growth mindset, promoting coping strategies that empower individuals to navigate adversity. This is crucial in rural settings where access to mental health services may be limited.
Enhancing Social Engagement: By empowering participants to explore their personal goals and values, TIMI helps identify pathways to meaningful social connections, promoting reintegration into community life.
Implementation in Rural Contexts
Adapting TIMI to rural environments necessitates a culturally sensitive approach. Training local healthcare providers, community leaders, and peer mentors in TIMI principles ensures sustainability. Additionally, integrating TIMI within existing community health frameworks, such as primary healthcare clinics or local support groups, facilitates accessibility.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional group | Experimental | Behavioral: Trauma-Informed Motivational InterviewingThis investigation will draw upon existing literature exploring the intersection of TIMI in Leprosy-Related Discrimination, Body Image Dissatisfaction, Resilience, and Social Engagement in Rural Dwelling Samples. By understanding how Threat to Identity and Meaning in Illness (TIMI) influences the psychological and social impact of leprosy-related discrimination. It explores how body image dissatisfaction affects self-perception and mental health while assessing resilience as a coping mechanism. Additionally, it examines social engagement in rural settings, where stigma may lead to isolation. The findings can inform targeted mental health interventions and stigma-reduction strategies to support affected individuals. |
| control group | Placebo comparator | Behavioral: Trauma-Informed Motivational Interviewingtraditional standardized care such as Group Therapy/ peer support. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals with a confirmed medical diagnosis of leprosy (current or past) experiencing physical, emotional, or social consequences.
Key exclusion criteria (2 listed)
- Severe Cognitive or Psychiatric Impairments:
- Individuals with severe mental health conditions (e.g., untreated psychosis, severe intellectual disabilities) that impede the reflective, goal-setting nature of Motivational Interviewing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trauma-Informed Motivational InterviewingTrauma-Informed Motivational Interviewing: Core Principles TIMI integrates two evidence-based approaches: Trauma-Informed Care (TIC) and Motivational Interviewing (MI). TIC emphasises understanding and acknowledging the impact of trauma on individuals' behaviours and emotional well-being. MI, a client-centred approach, fosters intrinsic motivation for change by exploring ambivalence and strengthening personal autonomy. | Behavioural | control group, interventional group |
Primary outcome
Leprosy-Related Discrimination
Time frame: 1 month and half
To assess the stigma surrounding leprosy, this scale comprises four domains: Experienced stigma, Disclosure concerns, Internalized stigma, and Anticipated stigma. Each domain aims to capture different facets of the stigma experienced by individuals affected by leprosy. With a total of 21 questions, the SARI Stigma Scale explores how patients encounter stigma in their daily lives. The scoring method used is that if the patient answers no, do not know, or it is not relevant, they will be given a score of zero, whereas if they answer yes, the patient will receive a score ranging from one to three depending on the frequency the patient experiences.
1 secondary outcome
Body Image Psychological Inflexibility Scale (BIPIS).
Time frame: 1 month and half
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
rasha eweida principal investigator
Alexandria University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trauma-Informed Motivational Interviewing in people with Discrimination, Perceived, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rasha eweida (+201286640701, rashapsych@alexu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Leprosy-Related Discrimination (time frame: 1 month and half). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.