Ignite Creation Date:
2025-12-24 @ 3:40 PM
Ignite Modification Date:
2025-12-27 @ 4:09 AM
Study NCT ID:
NCT07258992
Status:
COMPLETED
Last Update Posted:
2025-12-02
First Post:
2025-10-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of a Stress Management Program on Stress and Coping Styles in Emotionally Abused Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The program aimed to enhance participants' stress management and emotional regulation skills while fostering psychological empowerment. Conducted by a psychiatric nurse with a PhD, the program consisted of six weekly sessions (40-50 minutes each) delivered via Zoom."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-21', 'studyFirstSubmitDate': '2025-10-01', 'studyFirstSubmitQcDate': '2025-11-21', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in Perceived Stress Levels at Emotionally Abused Women Receiving the Online Stress Management Program', 'timeFrame': 'From enrollment to to the end of treatment at 6 weeks, one-month post-intervention, and three months post-intervention.', 'description': 'The scale is based on a 5-point Likert format, with scores ranging from 0 to 56'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Perceived Stress Levels at Emotionally Abused Women Receiving the Online Stress Management Program.', 'timeFrame': 'From enrollment to the end of treatment at 6 weeks, one-month post-intervention, and three months post-intervention.', 'description': 'The scale includes five subscales: Self-confident, Optimistic, Submissive, Helpless and Seeking of social support. Higher scores on each subscale indicate more frequent use of that coping strategy. The minimum and maximum possible scores for each subscale are as follows: Self-confident: 0-21 points, Optimistic: 0-15 points, Helpless: 0-24 points, Submissive: 0-18 points, and Seeking of Social Support: 0-12 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['emotionally abused', 'women', 'stress', 'stress management program', 'coping styles', 'randomized controlled tria'], 'conditions': ['Abused Women']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to examine the effectiveness of a structured stress management intervention in promoting healthier coping mechanisms and reducing perceived stress levels among emotionally abused young women. The main questions it aims to answer are:\n\nH1: Women who participate in the OSM program will show a significant reduction in perceived stress levels compared to the control group.\n\nH2: Women who participate in the OSM program will show a significant improvement in coping style levels compared to the control group.\n\nResearchers will compare a structured stress management program to usual conditions to see if it promotes healthier coping mechanisms and reduces perceived stress levels among emotionally abused young women.\n\nParticipants will:\n\nReceive a 6-week Online Stress Management Program Attend six weekly sessions (40-50 minutes each) delivered via Zoom'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Emotionally Abused Women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being female\n* over 18 years of age\n* scoring above the mean on the Emotional Abuse Perceived Scale\n* being a student at the university where the study was conducted\n* having internet access\n* not having any physical or mental health condition that could prevent participation\n\nExclusion Criteria:\n\n* being male\n* not over 18 years of age\n* scoring lower the mean on the Emotional Abuse Perceived Scale\n* having any physical or mental health condition that could prevent participation'}, 'identificationModule': {'nctId': 'NCT07258992', 'briefTitle': 'Effects of a Stress Management Program on Stress and Coping Styles in Emotionally Abused Women', 'organization': {'class': 'OTHER', 'fullName': 'Manisa Celal Bayar University'}, 'officialTitle': 'Strengthening the Psyche: An Online Stress Management Program on Stress and Coping Styles in Emotionally Abused Young Women', 'orgStudyIdInfo': {'id': '76988455-050.04-175123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'experimental group', 'description': 'The intervention group received a six-week Online Stress Management Program delivered via Zoom, consisting of weekly sessions lasting 40-50 minutes each.', 'interventionNames': ['Behavioral: Stress Management Program']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'No intervention was applied to 26 participants'}], 'interventions': [{'name': 'Stress Management Program', 'type': 'BEHAVIORAL', 'description': "The Stress Management Program was implemented with participants who met the eligibility criteria and completed the pretest. The program aimed to enhance participants' stress management and emotional regulation skills while fostering psychological empowerment. Conducted by a psychiatric nurse with a PhD, the program consisted of six weekly sessions (40-50 minutes each) delivered via Zoom.", 'armGroupLabels': ['experimental group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05100', 'city': 'Amasya', 'country': 'Turkey (Türkiye)', 'facility': 'Amasya University', 'geoPoint': {'lat': 40.65333, 'lon': 35.83306}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD will not be shared because of ethical considerations, privacy protection, and the sensitive nature of the data collected'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Manisa Celal Bayar University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Nihan Durgu', 'investigatorAffiliation': 'Manisa Celal Bayar University'}}}}