Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2026-01-01 @ 2:55 AM
Study NCT ID:
NCT05768308
Status:
UNKNOWN
Last Update Posted:
2023-03-21
First Post:
2023-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Online CBT Intervention for Students With Adjustment Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000275', 'term': 'Adjustment Disorders'}], 'ancestors': [{'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 216}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2023-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-16', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-03-02', 'lastUpdatePostDateStruct': {'date': '2023-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Adjustment disorder', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Adjustment disorder - The Adjustment Disorder New Module 20 (ADNM-20)'}], 'secondaryOutcomes': [{'measure': 'Change in Depression', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'The patient health questionnaire-9 (PHQ-9)'}, {'measure': 'Change in General Anxiety Disorder', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'General Anxiety Disorder-7 (GAD-7)'}, {'measure': 'Change in Stress', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Scale of experienced stress (PSS-10)'}, {'measure': 'Change in Satisfaction with life', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Satisfaction with life scale (SWLS)'}, {'measure': 'Change in Academic Adjustment', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Academic adjustment scale (AAS)'}, {'measure': 'Change in Experiential Avoidance', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Acceptance and Action Questionnaire'}, {'measure': 'Change in Cognitive Fusion', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Cognitive Fusion Questionnaire (CFQ)'}, {'measure': 'Change in Self-compassion', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Self Compassion Scale - Short Form (SCS-SF)'}, {'measure': 'Change in Mindfulness', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Five Facet Mindfulness Questionnaire (FFMQ-15)'}, {'measure': 'Change in Persevative thinking', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Perseverative Thinking Questionnaire (PTQ)'}, {'measure': 'Change in Mental well-being', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Warwick-Edinburgh Mental Well-being Scale (WEMWBS)'}, {'measure': 'Change in Cognitive functioning', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'Stroop Task (color-word)'}, {'measure': 'Change in Academic performance', 'timeFrame': 'measured at baseline, immediately after the interventions and 1 month follow up', 'description': 'This index will be based on a three recently received grades. The mean will be assessed.'}, {'measure': 'Change in Daily Depressogenic adjustment', 'timeFrame': '7 days during the first week of the intervention and 7 days during the sixth week of the intervention time', 'description': 'Measured in daily diaries. It will be measured by three items based on Becks triad.'}, {'measure': 'Change in Daily negative thinking', 'timeFrame': '7 days during the first week of the intervention and 7 days during the sixth week of the intervention time', 'description': 'Measured in daily diaries. Rumination and worrying. Daily worry measures will be measured with three items taken from Meyer et al. (1990).'}, {'measure': 'Change in Emotional regulation', 'timeFrame': '7 days during the first week of the intervention and 7 days during the sixth week of the intervention time', 'description': 'Measured in daily diaries. cognitive restructuring and emotional supression. This variables will be measured using one item (each scale) from Emotional Regulation Questionnaire (ERQ).'}, {'measure': 'Change in Self-compassion', 'timeFrame': '7 days during the first week of the intervention and 7 days during the sixth week of the intervention time', 'description': 'Measured in daily diaries, by three items from Self Compassion Scale (SCS).'}, {'measure': 'Change in Daily-affect', 'timeFrame': '7 days during the first week of the intervention and 7 days during the sixth week of the intervention time', 'description': 'Measured in daily diaries, based on circumplex model.'}, {'measure': 'Change in Procrastination', 'timeFrame': '7 days during the first week of the intervention and 7 days during the sixth week of the intervention time', 'description': 'Measured in daily diaries, by three items from The Pure Procrastination scale.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['adjustment disorder', 'students', 'internet psychological interventions', 'cognitive behavioural therapy'], 'conditions': ['Adjustment Disorders']}, 'referencesModule': {'references': [{'pmid': '38041148', 'type': 'DERIVED', 'citation': 'Juszczyk-Kalina A, Holas P, Farchione TJ. Effectiveness and mediators of change of an online CBT intervention for students with adjustment disorder-study protocol for a randomized controlled trial. Trials. 2023 Dec 1;24(1):777. doi: 10.1186/s13063-023-07744-9.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of online cognitive-behavioral intervention based on Unified Protocol and mediators of obtained changes among polish students with adjustment disorder. The intervention is fully self-helped and based on Unified Protocol principles. Control conditions contain of online progressive muscle relaxation group and waiting list.', 'detailedDescription': 'Adjustment problems are highly prevalent among students around the world (Conley et.al., 2013). Unfortunately only half of students in need receive psychological help (Eisenberg et al., 2018). For these reasons, there is a need to develop and evaluate new, more scalable forms of treatment for students with adjustment disorder - such as internet therapeutic programs. Therefore the aim of the present research is to evaluate the effectiveness of online cognitive-behavioural therapy intervention. Mediators of obtained changes will also be evaluated. The present study has a potential for the development of a scalable, well researched treatment option for students experiencing adjustment disorder - internet psychological intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* having a student status\n* 18 years old or older,\n* having access to the internet and using computer or smartphone,\n* meeting the diagnostic criteria of adjustment disorder based on a total sum score \\> 47,5 in ADNM-20 questionnaire\n* meeting diagnostic criteria for AjD in MINI Interview.\n\nExclusion Criteria:\n\n* an increased risk of suicidality intent or ideation (at least moderate scores on the MINI and/or a score \\> 2 on item 9 from the PHQ-9),\n* psychotic disorder, eating disorder, anti-social personality disorder and/or alcohol/substance use disorder as indicated by the MINI\n* receiving another psychological treatment at the start of the study\n* having no time for participation in program\n* receiving pharmacological psychiatric treatment not stabilized 6 weeks prior the start of the study'}, 'identificationModule': {'nctId': 'NCT05768308', 'acronym': 'Online CBT', 'briefTitle': 'Online CBT Intervention for Students With Adjustment Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University of Warsaw'}, 'officialTitle': 'Effectiveness and Mediators of Change of an Online CBT Intervention for Students With Adjustment Disorder - Study Protocol for a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '08/01/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Internet CBT-UP intervention (iCBT-UP)', 'description': 'Patricipants in the experimental group will receive online cbt intervention for students with adjustment disorder (iCBT-UP).', 'interventionNames': ['Behavioral: Internet CBT-UP intervention iCBT-UP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Internet Progressive Muscle Realxation Training (iPMR)', 'description': 'Participants from the active control group will receive progressive muscle relaxation training (iPMR).', 'interventionNames': ['Behavioral: Internet Progressive Muscle Realxation Training (iPMR)']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting List', 'description': 'Participants from the waiting list condition will receive access to the choosen intervention after 6-weeks waiting period.'}], 'interventions': [{'name': 'Internet CBT-UP intervention iCBT-UP', 'type': 'BEHAVIORAL', 'description': 'The self-helped internet intervention for students experiencing emotional difficulties, especially adjustment disorder. This intervention is based on transdiagnostic cbt principles - unified protocol (Barlow et al., 2018). It is a modular intervention consisting of six modules teaching different skills of dealing with emotions. Intervention is interactive and contains of video materials, quizes, texts and audio materials.', 'armGroupLabels': ['Internet CBT-UP intervention (iCBT-UP)']}, {'name': 'Internet Progressive Muscle Realxation Training (iPMR)', 'type': 'BEHAVIORAL', 'description': 'Participants from the active control group will receive progressive muscle relaxation training (iPMR) (Bernstein, Borkovec, Hazlett-Stevens, 2000). It is also a modular intervention and, similar to the i-cbt condition, consists of 5 modules. During the intervention, participants learn how to progressively tighten and relax different muscle groups.The first module is planned for two weeks and the rest of them for one week each. Intervention consists of video materials and audio guided relaxations. Participants are encouraged to train these relaxations once a day.', 'armGroupLabels': ['Internet Progressive Muscle Realxation Training (iPMR)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Aleksandra Juszczyk-Kalina, Msc', 'role': 'CONTACT', 'email': 'a.juszczyk@uw.edu.pl', 'phone': '22 554 97 05', 'phoneExt': '+48'}], 'overallOfficials': [{'name': 'Aleksandra Juszczyk-Kalina, Msc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Warsaw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Msc Aleksandra Juszczyk-Kalina', 'investigatorFullName': 'Aleksandra Juszczyk', 'investigatorAffiliation': 'University of Warsaw'}}}}