Ignite Creation Date:
2025-12-24 @ 7:52 PM
Ignite Modification Date:
2025-12-30 @ 5:21 PM
Study NCT ID:
NCT05686304
Status:
COMPLETED
Last Update Posted:
2024-02-28
First Post:
2023-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Internet-based Self-help Money Management Program Among Adult With Severe Mental Illness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 130}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-26', 'studyFirstSubmitDate': '2023-01-06', 'studyFirstSubmitQcDate': '2023-01-06', 'lastUpdatePostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-01-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Assessment in Financial Self-Efficacy on the Financial Self-Efficacy Scale at Post-Intervention Assessment and Follow-up Assessment', 'timeFrame': 'Before intervention, Immediately after intervention, and 4 weeks after intervention', 'description': 'The Financial Self-Efficacy Scale assess the change in a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).'}, {'measure': 'Change from Baseline Assessment in Financial Behaviour at Post-Intervention Assessment and Follow-up Assessment', 'timeFrame': 'Before intervention, Immediately after intervention, and 4 weeks after intervention', 'description': 'Change in financial behaviour is assessed by asking participants to indicate the extent to which they perform six positive financial behaviours in a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).'}, {'measure': 'Change from Baseline Assessment in Financial Attitude at Post-Intervention Assessment and Follow-up Assessment', 'timeFrame': 'Before intervention and Immediately after intervention, and 4 weeks after intervention', 'description': 'Change in financial attitude is assessed by asking participants to indicate their views about performing six positive financial behaviours in a 5-point Likert scale, ranging from 1 (strongly disagree) to 5 (strongly agree).'}, {'measure': 'Change from Baseline Assessment in Financial Well-Being on the CFPB Financial Well-Being Scale at Post-Intervention Assessment and Follow-up Assessment', 'timeFrame': 'Before intervention and Immediately after intervention, and 4 weeks after intervention', 'description': 'The CFPB Financial Well-Being Scale assess the change in a 5-point Likert scale, ranging from 0 (not at all) to 4 (completely).'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline Assessment in Psychological Wellbeing on the World Health Organisation-Five Well-Being Index (WHO-5) at Post-Intervention Assessment and Follow-up Assessment', 'timeFrame': 'Before intervention and Immediately after intervention, and 4 weeks after intervention', 'description': 'The WHO-5 assess the change in a 6-point Likert scale, ranging from 1 (at no time) to 6 (all of the time).'}, {'measure': 'Change from Baseline Assessment in Anxiety Symptom on the General Anxiety Disorder-7 (GAD-7) at Post-Intervention Assessment and Follow-up Assessment', 'timeFrame': 'Before intervention and Immediately after intervention, and 4 weeks after intervention', 'description': 'The GAD-7 assess the change in a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day).'}, {'measure': 'Change from Baseline Assessment in Depressive Symptom on the Patient Health Questionnaire-9 (PHQ-9) at Post-Intervention Assessment and Follow-up Assessment', 'timeFrame': 'Before intervention and Immediately after intervention, and 4 weeks after intervention', 'description': 'The PHQ-9 assess the change in a 4-point Likert scale, ranging from 0 (not at all) to 3 (nearly every day).'}, {'measure': 'Change from Baseline Assessment in Quality of Life on the Twelve-Item Short-Form (SF-12) Health Survey at Post-Intervention Assessment and Follow-up Assessment', 'timeFrame': 'Before intervention and Immediately after intervention, and 4 weeks after intervention', 'description': 'The SF-12 assess the change in a combination of 5-point and 3-point Likert scale, ranging respectively from 1 (poor/ never) to 5 (excellent/ very much), and 1 (never) to 3 (very much).'}, {'measure': 'Treatment adherence at the Interview after Post-Intervention Assessment', 'timeFrame': 'Immediately after Post-Intervention Assessment', 'description': 'Treatment adherence is assessed by asking participants to report the number of sessions they had read, how long they had spent on the program, and how far they had followed the instructions.'}, {'measure': 'Treatment satisfaction at the Interview after Post-Intervention Assessment', 'timeFrame': 'Immediately after Post-Intervention Assessment', 'description': 'Treatment satisfaction is assessed by asking participants to report whether they like the treatment and whether they found it useful in a 10-point Likert scale, ranging from not at all suitable to very suitable.'}, {'measure': 'Treatment satisfaction on the internet (Acceptability of the Internet for delivering online programs) at the Interview after Post-Intervention Assessment', 'timeFrame': 'Immediately after Post-Intervention Assessment', 'description': 'Acceptability of the Internet for delivering online programs is assessed by asking participants to report how suitable, how convenient, how much they liked, and how worried they were about their privacy in a 10-point Likert scale, ranging from not at all suitable to very suitable.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Money Management Program'], 'conditions': ['Severe Mental Illness']}, 'descriptionModule': {'briefSummary': 'This experimental study aims to develop an internet-based self-help money management program that improve financial self-efficacy and its associated adverse outcomes among adult population with severe mental illness. In particular, this study compares the efficacy of the internet-delivered self-help money management program with the wait-list control group.\n\nThe online money management program course will consist of 4 weekly modules, incorporating the key components of money management and the Model of Human Occupation (MOHO). The program include the concept of money management, money management skill, and risk of financial exploitation. The main component of each module will be presented in video format, quiz, and homework. Materials will be presented interactively to facilitate engagement.', 'detailedDescription': 'Money management is necessary for people with severe mental illness (SMI) to live safely in the community. Collective evidence has suggested that mental disorder leads to drift into poverty, is strong. Most of them struggle to meet basic needs with their existing income. Financial instability has been consistently linked to an increased risk of relapse. This experimental study aims to develop an internet-based self-help money management program that improve financial self-efficacy and its associated adverse outcomes among adult population with severe mental illness. Its efficacy will be compared with the wait-list control group. We hypothesized that (1) participants who received a money management program will improve financial self-efficacy after the intervention as compared with the wait-list controls; (2) participants from the money management program will have better financial well-being after the intervention as compared with the wait-list controls.\n\nThe online money management program course will consist of 4 weekly modules, incorporating the key components of money management and the Model of Human Occupation (MOHO), including the concept of money management, money management skill, and risk of financial exploitation. Each module will consist of the main component presented in video format, quiz, and homework. Materials will be presented interactively to facilitate engagement.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hong Kong residents\n* Age ≥18 years\n* Carrying a diagnosis of mental illness\n* Being able to read Chinese\n* Have a computer, tablet and/or smartphone device with Internet access\n* Willing to give informed consent and comply with the trial protocol\n\nExclusion Criteria:\n\nNil'}, 'identificationModule': {'nctId': 'NCT05686304', 'briefTitle': 'Effectiveness of Internet-based Self-help Money Management Program Among Adult With Severe Mental Illness', 'organization': {'class': 'OTHER', 'fullName': 'Education University of Hong Kong'}, 'officialTitle': 'Effectiveness of Internet-based Self-help Money Management Program in Increasing in Financial Self-efficacy Among the Adult Population With Severe Mental Illness: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2021-2022-0425'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Money management group', 'description': 'Participants in the money management condition start the 4-week money management program immediately after randomization and complete the post-intervention assessment right after they finish the treatment. They will be invited to participate in an interview after completing the post-intervention assessment.', 'interventionNames': ['Behavioral: Internet-based self-help money management program']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist control group', 'description': 'Participants in the waitlist control group will wait for 4 weeks without the money management program and then complete the post-intervention assessment. The waitlist control participants will start a money management program (equivalent to that of the money management group) immediately after completing the post-intervention assessment.'}], 'interventions': [{'name': 'Internet-based self-help money management program', 'type': 'BEHAVIORAL', 'description': 'The online money management program course will consist of 4 weekly modules, incorporating the key components of money management and the Model of Human Occupation (MOHO), including the concept of money management, money management skill, and risk of financial exploitation.', 'armGroupLabels': ['Money management group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '999077', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'Baptist Oi Kwan Social Service', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'zip': '999077', 'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'The Education University of Hong Kong', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}], 'overallOfficials': [{'name': 'Kevin, Ka Shing CHAN', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Education University of Hong Kong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Education University of Hong Kong', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baptist Oi Kwan Social Service', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Head of Department of Psychology', 'investigatorFullName': 'CHAN Ka Shing Kevin', 'investigatorAffiliation': 'Education University of Hong Kong'}}}}