Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:40 AM
Study NCT ID:
NCT07466004
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-12
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PERMA-Based Mobile Psychological Intervention With and Without Telephone Support for University Students
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092862', 'term': 'Psychological Well-Being'}], 'ancestors': [{'id': 'D010549', 'term': 'Personal Satisfaction'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 177}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-06', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-03-06', 'lastUpdatePostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline emotional well-being to post-intervention (5 weeks) and 6-month follow-up', 'timeFrame': 'Pre- and post -intervention (5 weeks) and 6-month follow-up', 'description': 'One of the primary outcomes of the study will be emotional well-being. This construct will be evaluated using the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS; Tennant et al., 2007).'}, {'measure': 'Change from baseline well-being to post-intervention (5 weeks) and 6-month follow-up', 'timeFrame': 'Pre- and post -intervention (5 weeks) and 6-month follow-up.', 'description': 'One of the primary outcomes of this study will be well-being (which comprises three elements, emotional, psychological and social well-being)l. This constructs will be evaluated using the Mental Health Continuum-Short Form (MHC-SF; Keyes, 2002).'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PERMA model', 'University students', 'Mobile intervention', 'Randomized controlled trial'], 'conditions': ['Psychological Well Being', 'Mental Health Promotion']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': 'Miltenberger, R. G. (2012). Behavior Modification: Principles and Procedures (5th ed). Wadsworth/Thomson Learning.'}, {'pmid': '11315248', 'type': 'BACKGROUND', 'citation': 'Fredrickson BL. The role of positive emotions in positive psychology. The broaden-and-build theory of positive emotions. Am Psychol. 2001 Mar;56(3):218-26. doi: 10.1037//0003-066x.56.3.218.'}, {'pmid': '12237980', 'type': 'BACKGROUND', 'citation': 'Locke EA, Latham GP. Building a practically useful theory of goal setting and task motivation. A 35-year odyssey. Am Psychol. 2002 Sep;57(9):705-17. doi: 10.1037//0003-066x.57.9.705.'}, {'pmid': '18042300', 'type': 'BACKGROUND', 'citation': 'Tennant R, Hiller L, Fishwick R, Platt S, Joseph S, Weich S, Parkinson J, Secker J, Stewart-Brown S. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS): development and UK validation. Health Qual Life Outcomes. 2007 Nov 27;5:63. doi: 10.1186/1477-7525-5-63.'}, {'pmid': '12096700', 'type': 'BACKGROUND', 'citation': 'Keyes CL. The mental health continuum: from languishing to flourishing in life. J Health Soc Behav. 2002 Jun;43(2):207-22.'}, {'type': 'BACKGROUND', 'citation': 'Dweck, C. S. (2006). Mindset: The new psychology of success. Random house.'}, {'type': 'BACKGROUND', 'citation': 'Steger, M. F. (2009). Meaning in life. In S. J. Lopez & C. R. Snyder (Eds.), The Oxford handbook of positive psychology (2nd ed., pp. 679-687). Oxford University Press.'}, {'type': 'BACKGROUND', 'citation': 'Reis, H. T., & Gable, S. L. (2003). Toward a positive psychology of relationships. In C. R. Snyder & S. J. Lopez (Eds.), Handbook of positive psychology (pp. 129-159). Oxford University Press.'}, {'type': 'BACKGROUND', 'citation': 'Peterson, C., & Seligman, M. E. P. (2004). Character strengths and virtues: A handbook and classification. Oxford University Press.'}, {'type': 'BACKGROUND', 'citation': 'Csikszentmihalyi, M. (1990). Flow: The psychology of optimal experience. Harper & Row.'}, {'type': 'BACKGROUND', 'citation': 'Seligman, M. E. (2011). Flourish: A visionary new understanding of happiness and well-being. Simon and Schuster.'}]}, 'descriptionModule': {'briefSummary': "University students face increasing academic and psychosocial demands that place them at risk of reduced psychological well-being. Positive psychology interventions have demonstrated efficacy in promoting mental health; however, few are grounded explicitly in Seligman's PERMA model and adherence to digital interventions remains limited. This randomized controlled trial aims to evaluate the efficacy of a brief PERMA-based psychological intervention delivered via a smartphone application, with and without supplementary telephone multiconference support, compared to a waiting list control group. The intervention consists of five weekly modules targeting Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment. Assessments will be conducted at baseline, post-intervention, and at six-month follow-up."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being an actively enrolled university student at the University of Santiago de Compostela (USC)\n* Having access to a smartphone with an internet connection.\n\nExclusion Criteria:\n\n* Having a current diagnosis of severe psychiatric disorder, including major depressive disorder with psychotic features, bipolar disorder, schizophrenia, severe cognitive impairment, dissociative disorders, or active substance dependence\n* Having started psychological or psychopharmacological treatment within the two months prior to the study or participating in another mental health-related study\n* Having insufficient proficiency in Spanish, or presenting sensory, cognitive, or physical impairments that would prevent engagement with the intervention\n* Planning to move out of Galicia within the next 12 months.'}, 'identificationModule': {'nctId': 'NCT07466004', 'briefTitle': 'PERMA-Based Mobile Psychological Intervention With and Without Telephone Support for University Students', 'organization': {'class': 'OTHER', 'fullName': 'University of Santiago de Compostela'}, 'officialTitle': 'Efficacy of a Positive Psychology-Based Psychological Intervention Grounded in the PERMA Model Delivered Via Smartphone App, With and Without Telephone Multiconference Support, for the Promotion of Psychological Well-Being in University Students', 'orgStudyIdInfo': {'id': 'USC-003/2026-H'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'App-based PERMA intervention (PPIA)', 'description': 'Behavioral intervention delivered via smartphone app. Five weekly modules corresponding to the PERMA domains.', 'interventionNames': ['Behavioral: App Based PERMA intervention']}, {'type': 'EXPERIMENTAL', 'label': 'App-based PERMA intervention plus telephone multiconference (PPIA+M)', 'description': 'Same app-based intervention supplemented by weekly 30-minute group telephone multiconference sessions.', 'interventionNames': ['Behavioral: App Based PERMA intervention plus telephone multiconference']}, {'type': 'NO_INTERVENTION', 'label': 'Waiting List Control Group (WLCG)', 'description': 'Participants receive no intervention during the study period and are granted access after completion.'}], 'interventions': [{'name': 'App Based PERMA intervention', 'type': 'BEHAVIORAL', 'description': 'The PPIA intervention is a structured psychological program grounded in the PERMA model of well-being (Seligman, 2011). This model proposes that long-term flourishing depends on developing five pillars: Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment. The intervention is further supported by the broaden-and-build theory of positive emotions (Fredrickson, 2001), flow theory (Csikszentmihalyi, 1990), research on character strengths and positive relationships (Peterson \\& Seligman, 2004; Reis \\& Gable, 2003), meaning in life (Steger, 2009), the goal-setting theory (Locke \\& Latham, 2002) and growth mindset principles (Dweck, 2006).', 'armGroupLabels': ['App-based PERMA intervention (PPIA)']}, {'name': 'App Based PERMA intervention plus telephone multiconference', 'type': 'BEHAVIORAL', 'description': "The PPIA intervention is a structured psychological program grounded in the PERMA model of well-being (Seligman, 2011). This model proposes that long-term flourishing depends on developing five pillars: Positive Emotion, Engagement, Relationships, Meaning, and Accomplishment. The intervention is further supported by the broaden-and-build theory of positive emotions (Fredrickson, 2001), flow theory (Csikszentmihalyi,1990), research on character strengths and positive relationships (Peterson \\& Seligman, 2004; Reis \\& Gable, 2003), meaning in life (Steger, 2009), the goalsetting theory (Locke \\& Latham, 2002) and growth mindset principles (Dweck, 2006). Additionally, the multiconference component will consist of weekly 30-minute telephone-based multiconference sessions. During these sessions, positive or corrective feedback will be delivered in accordance with Miltenberger's guidelines (Miltenberger, 2012) after reviewing the completed homework.", 'armGroupLabels': ['App-based PERMA intervention plus telephone multiconference (PPIA+M)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vanessa Blanco, Professor', 'role': 'CONTACT', 'email': 'vanessa.blanco@usc.es', 'phone': '+34 881813744'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Researchers will report study results through publications. The data supporting these findings will be presented in the main publications, and the datasets used during the study can be obtained from the corresponding author on reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Santiago de Compostela', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Vanessa Blanco Seoane', 'investigatorAffiliation': 'University of Santiago de Compostela'}}}}