ClinicalTrials.gg
RecruitingNCT06909734Updated Apr 23, 2025

Trauma-Informed Motivational Interviewing in Rural Dwelling Samples

An interventional study of Trauma-Informed Motivational Interviewing in Discrimination, Perceived, sponsored by Alexandria University. Recruiting at 1 site in Egypt. Open to participants aged 25 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-04-23.

Sponsored by Alexandria University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Mar 2025; still recruiting 1 year 8 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Discrimination, Perceived

Browse trials for

Keywords

  • Leprosy
  • Discrimination
  • Body Image
  • Resilience
  • Social
03

In context

Leprosy

52 studies on the registry are indexed under Leprosy; 13 are open to participants now.

This study's planned enrollment of 70 is close to the median of 70 across 41 interventional studies indexed under Leprosy.

Browse Leprosy studies →

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Individuals with a confirmed medical diagnosis of leprosy (current or past) experiencing physical, emotional, or social consequences.

Exclusion criteria

Exclusion Criteria:

  • 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.

05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    interventional group

    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.

    Behavioral: Trauma-Informed Motivational Interviewing

  • Placebo comparator
    control group

    traditional standardized care such as Group Therapy/ peer support.

    Behavioral: Trauma-Informed Motivational Interviewing

Interventions

  • BehavioralTrauma-Informed Motivational Interviewing

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 1 month and half

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2025 (actual). Primary completion is estimated for Sep 2025, 6 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 22, 2025
First posted
Apr 3, 2025
StartActual
Mar 1, 2025
Primary completionEst.
Sep 20, 2025
CompletionEst.
Dec 30, 2025
Last update
Apr 23, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06909734
Responsible party
Rasha salah elsayed eweida (Rasha Eweida, Alexandria University) — Principal investigator
First posted
Apr 3, 2025
Start date
Mar 1, 2025
Primary completion
Sep 20, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Apr 23, 2025

Study contacts

rasha eweida
Contact
rashapsych@alexu.edu.eg
+201286640701
rasha eweida
principal investigator · Alexandria University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion