Ignite Creation Date:
2025-12-24 @ 11:50 PM
Ignite Modification Date:
2025-12-25 @ 9:45 PM
Study NCT ID:
NCT06825351
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-13
First Post:
2025-02-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059020', 'term': 'Suicidal Ideation'}], 'ancestors': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-09', 'studyFirstSubmitDate': '2025-02-09', 'studyFirstSubmitQcDate': '2025-02-09', 'lastUpdatePostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Suicidal Ideation Attributes Scale', 'timeFrame': '3 months', 'description': 'It is a brief and reliable tool for assessing the severity of suicidal ideation over the past month, was developed by Van Spijker et al, (2014). It comprises five items that evaluate the frequency of suicidal thoughts, the level of control over these thoughts, proximity to a suicide attempt, the distress caused by the thoughts, and their impact on daily functioning.'}, {'measure': 'The Attitudes Toward Seeking Professional Psychological Help-Short Form', 'timeFrame': '3 months', 'description': 'It is a 10-item scale to evaluate attitudes toward seeking psychological help. Responses are rated on a 4-point Likert scale ranging from 0 to 3, with higher scores indicating more favourable attitudes and lower stigma associated with mental illness'}, {'measure': 'Perception of Academic Stress Scale', 'timeFrame': '3 months', 'description': 'It was developed by Bedewy, D., \\& Gabriel, A. (2015), to measure sources of academic stress among university students. PAS IS an 18-item, 5-point Likert-type questionnaire designed, with a higher score indicating higher academic stress.'}, {'measure': 'The Brief Resilience Scale', 'timeFrame': '3 months', 'description': "It is a six-item self-report measure designed to assess resilience by Smith et al. (2008), specifically focusing on an individual's ability to bounce back or recover from stress. Unlike other resilience scales emphasizing resources or traits promoting resilience, the BRS directly evaluates recovery and adaptability following stressful events."}, {'measure': 'The Self-Compassion Scale', 'timeFrame': '3 months', 'description': 'It was developed by Dr. Kristin Neff, is a widely recognized tool designed to measure self-compassion, which encompasses being kind and understanding toward oneself in times of difficulty.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Suicidal Ideation']}, 'descriptionModule': {'briefSummary': 'his feasibility study aims to compare the effectiveness of Psychological First Aid (PFA) and Dialectical Behavior Therapy (DBT) interventions in reducing suicide risk among undergraduate students. The study employs a crossover randomized controlled trial design, allowing participants to experience both interventions at different times.', 'detailedDescription': 'Suicide risk among undergraduate students is a pressing mental health concern, exacerbated by academic pressures and social isolation. Psychological First Aid (PFA) is a supportive intervention designed to reduce distress and foster coping in the immediate aftermath of a crisis. Conversely, Dialectical Behavior Therapy (DBT) is a structured, evidence-based therapy that focuses on emotional regulation, interpersonal effectiveness, and distress tolerance. This study explores the feasibility and effectiveness of these two interventions in a university setting.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '27 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nParticipants in this feasibility study must be undergraduate students aged 18-25 years who are identified as at risk for suicide based on a validated screening tool. They must be currently enrolled in a degree program, able to provide informed consent, and proficient in English.\n\nExclusion Criteria:\n\nIndividuals with severe mental illnesses (e.g., schizophrenia, bipolar disorder), those in acute crisis requiring immediate intervention, current substance abuse issues, significant cognitive impairments, prior experience with DBT or similar therapies within the last year, and physical health conditions that could complicate participation.'}, 'identificationModule': {'nctId': 'NCT06825351', 'briefTitle': 'A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'A Feasibility Study of Psychological First Aid Versus Dialectal Behavioral Intervention in Undergraduate Students With Suicide Risk: A Comparative Crossover Randomized ControlledTrial', 'orgStudyIdInfo': {'id': '2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Participants: Undergraduate students identified as at risk for suicide. Interventions: Participants will receive both PFA and DBT at different times. PFA: Focuses on immediate emotional support and connecting students to resources.\n\nDBT: A structured program that teaches coping skills, emotional regulation, and interpersonal effectiveness.', 'interventionNames': ['Behavioral: Psychological First Aid versus Dialectal behavioral Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Group A: Begins with PFA followed by DBT. Group B: Begins with DBT followed by PFA.', 'interventionNames': ['Behavioral: Psychological First Aid versus Dialectal behavioral Intervention']}], 'interventions': [{'name': 'Psychological First Aid versus Dialectal behavioral Intervention', 'type': 'BEHAVIORAL', 'description': "PFA is an immediate, supportive intervention aimed at helping individuals in distress. It focuses on providing emotional support and practical assistance in the aftermath of a crisis.\n\nKey Components:\n\nSafety and Comfort: Ensuring that participants feel safe and secure in their environment.\n\nActive Listening: Engaging in empathetic listening to validate participants' feelings and experiences.\n\nAssessment of Needs: Identifying immediate needs and concerns, including emotional and practical aspects.\n\nInformation and Resources: Providing clear information about available resources, such as mental health services and coping strategies.\n\nEncouragement of Social Support: Guiding participants to connect with friends, family, or support groups.", 'armGroupLabels': ['Control', 'Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Qina', 'country': 'Egypt', 'facility': 'South Valley Committee', 'geoPoint': {'lat': 26.16418, 'lon': 32.72671}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr Mahmoud Khedr', 'investigatorFullName': 'Mahmoud Khedr', 'investigatorAffiliation': 'Alexandria University'}}}}