Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2026-01-05 @ 2:49 AM
Study NCT ID:
NCT02532504
Status:
COMPLETED
Last Update Posted:
2017-01-16
First Post:
2015-08-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Change Your Life With Seven Sheets of Paper
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-13', 'studyFirstSubmitDate': '2015-08-15', 'studyFirstSubmitQcDate': '2015-08-22', 'lastUpdatePostDateStruct': {'date': '2017-01-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-08-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edinburgh Postnatal Depression Scale (EPDS)', 'timeFrame': 'Change in scores from baseline to 3rd month', 'description': 'EPDS will be used to assess postnatal depression'}], 'secondaryOutcomes': [{'measure': 'Patient health Questionnaire-9', 'timeFrame': 'Change in scores from baseline to 3rd month', 'description': 'PHQ-9 will be used to assess severity of depression'}, {'measure': 'World Health Organization Quality of Life', 'timeFrame': 'Change in scoares from baseline to 3rd month'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['postnatal depression', 'Cognitive behaviour Therapy', 'Traditional Birth Attendants', 'low income country'], 'conditions': ['Postnatal Depression']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to deliver CBT based intervention called "Change your life with 7 Sheets of paper" to women with mild to moderate postnatal depression (PND) through trained traditional birth attendants (TBAs). Participants will be recruited from low income area in Karachi Pakistan. Edinburg Postnatal Depression scale (EPDS) will be used to screen mothers having children between birth till 12 months. Group intervention will be delivered through trained TBAs.', 'detailedDescription': 'The prevalence rate of PND in Pakistani women and its effect on the growth and development of young children and child mortality is very high. Despite availability of interventions to improve maternal health, the major issue in implementation of those interventions is because of limited availability of trained health professionals . Therefore the aim of this study is to train TBAs in delivering Cognitive Behaviour Therapy (CBT) based intervention called "Changing your life with seven sheets of paper". Participants will be recruited from low income area in Karachi. Total 36 participants will be recruited and randomized into 2 groups; intervention and Treatment As Usual (TAU) group. Total 8 sessions will be delivered by trained TBAs over the period of 3 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Mothers with a child between 0-12 months\n* Women who score 14 or above on Edinburgh Postnatal Depression scale (EPDS)\n* Age range between 18 to 45 years\n* Women able to provide written informed consent.\n\nExclusion Criteria:\n\n* Severe depression or any other major psychiatric disorder\n* Severe suicidal ideation\n* Currently receiving any psychiatric or psychological treatment\n* Intellectual disability in mother\n* Chronic medical condition\n* Having children with intellectual or physical disability'}, 'identificationModule': {'nctId': 'NCT02532504', 'acronym': 'CREATOR', 'briefTitle': 'Change Your Life With Seven Sheets of Paper', 'organization': {'class': 'OTHER', 'fullName': 'Pakistan Institute of Living and Learning'}, 'officialTitle': 'Change Your Life With Seven Sheets of Paper: A Pilot Randomized Controlled Trial for Postnatal Depression: A Pilot Randomized Controlled Trial for Postnatal Depression', 'orgStudyIdInfo': {'id': 'CREATOR001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBT seven sheets', 'description': '8 sessions of CBT based intervention called "change your life with seven sheets of paper"', 'interventionNames': ['Other: CBT']}, {'type': 'NO_INTERVENTION', 'label': 'Treatment As Usual', 'description': 'Treatment As Usual'}], 'interventions': [{'name': 'CBT', 'type': 'OTHER', 'description': '8 sessions of CBT based intervention called "change your life with seven sheets of paper by Prof. Chris Williams. These sheets cover key skills of CBT that are;\n\n1. Five Areas vicious circle\n2. Bad thought spotter\n3. Amazing Bad thought Busting Programme (ABTPB)\n4. Easy 4 Step plan\n5. Things you do that mess you up/Confidence sheet\n6. Happy List/ Things you do that boost how you feel sheet\n7. Planner and Review sheets', 'armGroupLabels': ['CBT seven sheets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Karachi', 'country': 'Pakistan', 'facility': 'Orangi Town', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Batool Fatima', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pakistan Institute of Living and Learning'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pakistan Institute of Living and Learning', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}