Ignite Creation Date:
2025-12-25 @ 2:29 AM
Ignite Modification Date:
2025-12-28 @ 10:44 PM
Study NCT ID:
NCT06907134
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-12-02
First Post:
2024-12-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Purpose of the Study is to Investigate if a Smartphone App Combined With Internet Based Cognitive Behavioural Therapy (ICBT) Leads to Improved Symtoms in Depressive Adults on Antidepressive Medicine, Compared to a Wait-list Control Condition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'After the recruitment is finished, participants will be randomized to either ICBT treatment combined with a smartphone app or wait-list control condition.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-11-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-24', 'studyFirstSubmitDate': '2024-12-20', 'studyFirstSubmitQcDate': '2025-03-31', 'lastUpdatePostDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Patient Health Questionnaire - 4', 'timeFrame': 'From enrollment on a weekly basis through study completion 9 weeks later.', 'description': 'Brief measurer of depressive and anxiety symptoms. Consists of 4 items, scored from 0-3. A higher score indicates more symptoms.'}, {'measure': 'Client Satisfaction Questionnaire', 'timeFrame': 'At week 9 following enrollment.', 'description': 'CSQ is used to assess client satisfaction with health and human services. Total scores range from. 8 to 32, with the higher number indicating greater satisfaction.'}, {'measure': 'The Morisky Medication Adherence Scale', 'timeFrame': 'From enrollment to end of treament at 9 weeks.', 'description': 'The Morisky Medication Adherence Scale (MMAS-8) is an 8-item structured, self-report measure that assesses medication adherence. Higher scores indicates higher adherence'}], 'primaryOutcomes': [{'measure': 'Montgomery Asberg Depression Ranging Scale (MADRS)', 'timeFrame': 'From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.', 'description': 'MADRS-S is a questionnaire including nine questions about depressive mental states. The questions aslo address experienced worry, ability to concentrate and initiative. Each question gives between 0 and 6 points. Maximum score is 54 points. Higher scores indicate higher levels of depression.'}], 'secondaryOutcomes': [{'measure': 'Generalized Anxiety Disorder-7', 'timeFrame': 'From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.', 'description': 'Measures symptoms of anxiety. 7 items scored from 0-3, with a higher score indicating more anxiety symptom'}, {'measure': 'Brunnsviken Brief Quality of life scale', 'timeFrame': 'From enrollment to end of treament at 9 weeks. Follow-ups at 24 and 36 months after end of treatment.', 'description': 'Measures quality of life. 12 items scored from 0-4. A higher score indicates higher quality of life'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['depressive symtoms', 'smartphone app', 'mobile game', 'internet-based cognitive behavioural therapy'], 'conditions': ['Depressive Symptoms']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to investigate if a smartphone app combined with internet delivered cognitive behavioural therapy (ICBT) leads to improved symptoms in depressive adults on antidepressive mediation. The participants in the treatment group will get access to a smartphone app based on CBT-principles for 9 weeks. They will also get access to an internet platform with extra treatment material based on CBT and receive therapist support on demand. Participants will be recruited in Sweden with nationwide recruitment.', 'detailedDescription': 'This study is a randomized controlled trial with the aim to investigate if an smartphone app in combination with ICBT can help adults (+18) on antidepressant medication who still suffers from depressive symptoms. Participants will either be randomized to a treatment phase for 9 weeks or to a wait-list control. The treatment primarily contains the installation and usage of a smartphone app where the participants can engage in a serious mobile game based on CBT-principles. They will receive access to a secure internet platform where they can find general guidelines about the app, and extra treatment modules (to use if needed). They will receive support on demand from a therapist during the whole treatment period.\n\nPrimary outcome measure is depressive symptoms (measured on the MADRAS scale). Secondary outcome measures will include measures of anxiety and quality of life. Pre-treatment measurement, post-treatment measurement, weekly measure, and 24 \\& 36 months follow up is planned to be collected through an online survey.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ongoing drug treatment with an antidepressant mediated by an established care contact in (primary) care.\n* 18 years or older.\n* Be able to speak, read and write Swedish.\n* Have access to a computer, tablet or other device with internet connection and smartphone to download the app.\n\nExclusion Criteria:\n\n* Severe psychiatric or somatic problems that make participation difficult or impossible\n* Ongoing abuse (via Audit and during interview)\n* Acute suicidality\n* Other ongoing psychological treatment or planned investigation.\n* Planned dose change of medicine or change of medicine during pre-measurement.'}, 'identificationModule': {'nctId': 'NCT06907134', 'acronym': 'FIG', 'briefTitle': 'The Purpose of the Study is to Investigate if a Smartphone App Combined With Internet Based Cognitive Behavioural Therapy (ICBT) Leads to Improved Symtoms in Depressive Adults on Antidepressive Medicine, Compared to a Wait-list Control Condition', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'A Controlled Trial of Smartphone-delivered Cognitive Behavioral Therapy for Adults Treated With Medication for Depressive Symptoms', 'orgStudyIdInfo': {'id': 'FIG'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smartphone delivered Internet-based Cognitive Behavioural Therapy', 'description': 'The treatment consist of a 9 week long ICBT intervention based on an smartphone app with therapist support on demand.', 'interventionNames': ['Behavioral: Smartphone delivered internet-based Cognitive Behavioural Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention: Wait-list control condition', 'description': 'Wait-list control condition, participants have the option to contact the treatment team in case of worsened symptoms.'}], 'interventions': [{'name': 'Smartphone delivered internet-based Cognitive Behavioural Therapy', 'type': 'BEHAVIORAL', 'description': 'The intervention is 9 week long were partipants use an smartphone app based on CBT-principles with while having access to an internet platform where extra working material and therapist support is available on demand.', 'armGroupLabels': ['Smartphone delivered Internet-based Cognitive Behavioural Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58183', 'city': 'Linköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified individual participant data will be shared on request following initial publication of results.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, Professor', 'investigatorFullName': 'Gerhard Andersson', 'investigatorAffiliation': 'Linkoeping University'}}}}