Ignite Creation Date:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-27 @ 8:38 AM
Study NCT ID:
NCT06909734
Status:
RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trauma-Informed Motivational Interviewing in Rural Dwelling Samples
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000091563', 'term': 'Perceived Discrimination'}, {'id': 'D007918', 'term': 'Leprosy'}], 'ancestors': [{'id': 'D063508', 'term': 'Social Discrimination'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D009165', 'term': 'Mycobacterium Infections, Nontuberculous'}, {'id': 'D009164', 'term': 'Mycobacterium Infections'}, {'id': 'D000193', 'term': 'Actinomycetales Infections'}, {'id': 'D016908', 'term': 'Gram-Positive Bacterial Infections'}, {'id': 'D001424', 'term': 'Bacterial Infections'}, {'id': 'D001423', 'term': 'Bacterial Infections and Mycoses'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2025-03-22', 'studyFirstSubmitQcDate': '2025-03-27', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Leprosy-Related Discrimination', 'timeFrame': '1 month and half', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Body Image Psychological Inflexibility Scale (BIPIS).', 'timeFrame': '1 month and half', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Leprosy', 'Discrimination', 'Body Image', 'Resilience', 'Social'], 'conditions': ['Discrimination, Perceived']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "Introduction\n\nLeprosy 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.\n\nUnderstanding the Psychological Impact of Leprosy\n\nLeprosy-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.\n\nTrauma-Informed Motivational Interviewing: Core Principles\n\nTIMI 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.\n\nThe synergy of TIMI rests on five core principles:\n\nSafety: Ensuring physical and emotional safety in all interactions.\n\nTrustworthiness and Transparency: Building a collaborative, open relationship.\n\nPeer Support and Empowerment: Encouraging individuals to harness personal and community strengths.\n\nCollaboration and Mutuality: Shifting the power dynamic to promote shared decision-making.\n\nCultural, Historical, and Gender Awareness: Respecting cultural narratives and addressing systemic inequalities.\n\nAddressing Key Psychosocial Challenges\n\nCombatting 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.\n\nImproving 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.\n\nBuilding 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.\n\nEnhancing 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.\n\nImplementation in Rural Contexts\n\nAdapting 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals with a confirmed medical diagnosis of leprosy (current or past) experiencing physical, emotional, or social consequences.\n\nExclusion Criteria:\n\n* Severe Cognitive or Psychiatric Impairments:\n\nIndividuals with severe mental health conditions (e.g., untreated psychosis, severe intellectual disabilities) that impede the reflective, goal-setting nature of Motivational Interviewing.'}, 'identificationModule': {'nctId': 'NCT06909734', 'briefTitle': 'Trauma-Informed Motivational Interviewing in Rural Dwelling Samples', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Trauma-Informed Motivational Interviewing as a Frontrunner Paradigm for Addressing Leprosy-Related Discrimination, Body Image Dissatisfaction, Resilience, and Social Engagement in Rural Dwelling Samples', 'orgStudyIdInfo': {'id': '2232025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'interventional group', 'description': '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.', 'interventionNames': ['Behavioral: Trauma-Informed Motivational Interviewing']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'control group', 'description': 'traditional standardized care such as Group Therapy/ peer support.', 'interventionNames': ['Behavioral: Trauma-Informed Motivational Interviewing']}], 'interventions': [{'name': 'Trauma-Informed Motivational Interviewing', 'type': 'BEHAVIORAL', 'description': "Trauma-Informed Motivational Interviewing: Core Principles\n\nTIMI 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.", 'armGroupLabels': ['control group', 'interventional group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21523', 'city': 'Alexandria', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Rasha Eweida', 'role': 'CONTACT', 'email': 'rashapsych@alexu.edu.eg', 'phone': '01286640701'}], 'facility': 'Faculty of Nursing', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'centralContacts': [{'name': 'rasha eweida', 'role': 'CONTACT', 'email': 'rashapsych@alexu.edu.eg', 'phone': '+201286640701'}], 'overallOfficials': [{'name': 'rasha eweida', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Rasha Eweida', 'investigatorFullName': 'Rasha salah elsayed eweida', 'investigatorAffiliation': 'Alexandria University'}}}}