- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07228260
Testi di Aiuto per l'Intervento sul Lutto per Studenti Universitari in Lutto
The proposed study aims to evaluate the effectiveness of Help Texts, a weekly text-based program, among bereaved students at UCLA. Specifically, the study will evaluate whether Help Texts reduces grief severity and symptoms of depression, and whether it improves academic functioning (e.g., graduation, grades, student enrollment retention).
The investigators hypothesize that bereaved UCLA students who receive a 12-month Help Texts weekly digital text intervention will have reduced grief severity and depressive symptoms and increased academic functioning compared to bereaved UCLA students in a waitlist control condition receiving treatment as usual (i.e., list of resources for grief).
Participants will complete surveys at four timepoints: baseline and 3 months, 6 months, and 12 months following enrollment. They will be randomly assigned to either the treatment condition (receive 12-month Help Texts subscription at enrollment) or the waitlist control condition (receive list of resources for grief at enrollment, and receive 12-month Help Texts subscription at 6 months following enrollment). The Help Texts program involves texts offering psychoeducation related to grief and coping strategies, delivered twice weekly.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Grief and loss are common occurrences among students on college campuses but are inadequately addressed and associated with a number of negative outcomes. A mixed methods study of grieving students on a large campus found that 60% of those surveyed within a 3-year period at UCLA reported experiencing the loss of a loved one, but only 8% reported using campus resources to aid them during their grief, and only 38% sought resources off-campus (e.g., therapy, support groups, psychiatry). Numerous barriers to accessing grief support resources have been identified, including not knowing about them or perceiving them to be inadequate. Moreover, over one-third of participants interviewed in the study noted stigma associated with help-seeking. Despite a high prevalence of experiences of grief among students, resource utilization for supporting bereavement remains low.
Help Texts offers text message-based grief support, overcoming the barriers of access and stigma by providing up to a year of private, evidence-based grief support developed by clinical psychologists. Help Texts is an established company (specifically, a Public Benefit Corporation) and is currently in use. It was founded in 2018 and comprises a fully remote, 7-person team with over 100+ additional Expert Contributors providing expertise on different types of loss (e.g., the loss of a sibling, child, parent, partner; loss to cancer, dementia, suicide, COVID-19, etc); and the unique risks associated with being a caregiver, veteran, or member of the LGBTQIA2S+ or Black, Indigenous, and People of Color (BIPOC) communities. Help Texts is delivering support in 57 countries, in all 50 states in the U.S., and in 27 languages.
Help Texts provides twice-weekly, one-way texts offering basic grief education by normalizing and validating the grief experience and then offering tips for coping within various themes around grief. Preliminary evidence suggests that bereaved users of HelpTexts have found it supportive; 95% of all users rated their satisfaction with HelpTexts as a 4 or 5 out of 5 and found the text messages helpful. The proposed study is a randomized control trial that aims to evaluate the effectiveness of Help Texts to grieving students at UCLA in reducing grief severity and symptoms of depression, preventing prolonged grief and major depressive disorder, and in improving quality of life and occupational functioning (e.g., graduation, grades, student enrollment retention).
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Michelle Chang, M.A., C.Phil
- Numero di telefono: (323) 284-4695
- Email: changmichelle@g.ucla.edu
Backup dei contatti dello studio
- Nome: Theodore F. Robles, Ph.D.
- Numero di telefono: (310) 794-9362
- Email: robles@psych.ucla.edu
Luoghi di studio
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California
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Los Angeles, California, Stati Uniti, 90095
- Reclutamento
- Franz Hall
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Contatto:
- Michelle Chang, M.A.
- Numero di telefono: 3232844695
- Email: griefstudy@ucla.edu
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Investigatore principale:
- Theodore Robles, Ph.D.
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Enrolled UCLA student
- At least 18 years old
- Experienced death of a close person in the past 12 months
- Able to read English
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Altro: Waitlist Control with Treatment as Usual
At study enrollment, participants receive treatment as usual--a list of resources relevant to grief. At 6 months following study enrollment, participants will receive a 12-month subscription to Help Texts, a text-based intervention that delivers two texts per week providing bereavement psychoeducation, validation, and coping strategies. |
Participants will receive treatment as usual, consisting of a list of resources for coping with grief both on-campus and off-campus Help Texts delivers texts twice a week over a period of 12-months to provide psychoeducation, validation, and coping strategies relevant to bereavement. The The texts offer some customization in specifying the name of the participant and their deceased loved one, as well as providing texts relevant to the participants' cause of bereavement and relationship to their deceased loved one.
Altri nomi:
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Comparatore attivo: Treatment
At study enrollment, participants will receive a 12-month subscription to Help Texts, a text- based intervention that delivers two texts per week providing bereavement psychoeducation, validation, and coping strategies. |
Help Texts delivers texts twice a week over a period of 12-months to provide psychoeducation, validation, and coping strategies relevant to bereavement. The The texts offer some customization in specifying the name of the participant and their deceased loved one, as well as providing texts relevant to the participants' cause of bereavement and relationship to their deceased loved one.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Prolonged Grief Disorder-Revised (PG-13-R)
Lasso di tempo: 0 months, 3 months, 6 months, 12 months following enrollment
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PG-13-R measures symptoms of Prolonged Grief Disorder (PGD) mapping onto the Diagnostic and Statistical Manual's conceptualization of clinical grief. The measure assesses symptoms such as yearning for the deceased close person, avoiding reminders of their death, and feelings of loneliness in relation to the death. Each item is rated from 1 (Not at all) to 5 (Overwhelmingly). Total scores range from 10 to 50, with higher scores representing more severe prolonged grief. |
0 months, 3 months, 6 months, 12 months following enrollment
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Patient Health Questionnaire (PHQ-3)
Lasso di tempo: 0 months, 3 months, 6 months, 12 months following enrollment
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The PHQ-3 measures symptoms of depression over the last 2 weeks, including loss of interest in things, feeling down or hopeless, and feeling tired. Each item is rated from 0 (Not at all) to 3 (Nearly every day). Total scores range from 0 to 9, with higher scores representing more severe symptoms of depression. |
0 months, 3 months, 6 months, 12 months following enrollment
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Academic Functioning - GPA
Lasso di tempo: 0 months, 3 months, 6 months, 12 months following enrollment
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Participants' current overall GPA will be measured. From highest to lowest, the GPA options will be the following: A+, A, A-, B+, B, B-, C+, C, C-, D+ or below, with A+ representing the highest possible current overall GPA. |
0 months, 3 months, 6 months, 12 months following enrollment
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Academic Functioning - Negative Impacts to Academic Performance
Lasso di tempo: 0 months, 3 months, 6 months, 12 months following enrollment
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The investigators will assess the number of days that participants felt that emotional or mental difficulties hurt their academic performance. Participants can select the following options: None (0), 1-2 days (1), 3-5 days (2), 6 or more days (3), with scores ranging from 0 to 3. Higher scores indicate more days that participants felt their academic performance was hurt by their emotional or mental difficulties. |
0 months, 3 months, 6 months, 12 months following enrollment
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Academic Functioning - Class Enrollment Status
Lasso di tempo: 0 months, 3 months, 6 months, 12 months following enrollment
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Participants will indicate whether or not they are currently registered for classes at UCLA. They will respond Yes (1) or No (0), with a higher score indicating that they are currently registered for classes. |
0 months, 3 months, 6 months, 12 months following enrollment
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Academic Functioning - Dropped Course
Lasso di tempo: 0 months, 3 months, 6 months, 12 months following enrollment
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Another academic outcome measured will be whether or not participants dropped a course in the past quarter. This will be dichotomously scored as Yes (1) or No (0), with a higher score indicating endorsement of having dropped a course in the past quarter. |
0 months, 3 months, 6 months, 12 months following enrollment
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Generalized Anxiety Disorder-7 (GAD-7)
Lasso di tempo: 0 months, 3 months, 6 months, 12 months following enrollment
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The GAD-7 will assess symptoms of generalized anxiety over the past 2 weeks consistent with the Diagnostic and Statistical Manual's conceptualization of generalized anxiety. It will assess symptoms such as being unable to control worrying and having difficulty relaxing. Items will be scored from 0 (Not at all) to 3 (Nearly every day). Total scores will range from 0 to 21, with higher scores indicating more severe symptoms of generalized anxiety. |
0 months, 3 months, 6 months, 12 months following enrollment
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Collaboratori e investigatori
Pubblicazioni e link utili
Pubblicazioni generali
- Levesque DA, Lunardini MM, Adams SN, Payne EL, Neumann BG. Grief Coach: Feasibility and acceptability of a text message program for bereavement support among grievers in the United Kingdom. Death Stud. 2025;49(4):391-402. doi: 10.1080/07481187.2024.2334080. Epub 2024 Apr 4.
- Chang M, Panda S, Tajrian M, Kim WI, Dunkel Schetter C, Robles TF. Bereavement, resource utilization, and collective grieving since the COVID pandemic: Mixed-methods study of university students and staff. 2024.
- Varga MA, Lanier B, Biber D, Stewart B. Holistic Grief Effects, Mental Health, and Counseling Support in Bereaved College Students. College Student Affairs Journal. 2021;39(1):1-13. doi: 10.1353/csj.2021.0000.
- Sirrine EH, Kliner O, Gollery TJ. College Student Experiences of Grief and Loss Amid the COVID-19 Global Pandemic. Omega (Westport). 2023 Aug;87(3):745-764. doi: 10.1177/00302228211027461. Epub 2021 Jun 23.
- Jones S, Martini M. Sense of self, depression and adaption to grief, in emerging adults who suffered parental loss. Current Psychology. 2023;42(7):5212-25. doi: 10.1007/s12144-021-01843-z.
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Completamento dello studio (Stimato)
Date di iscrizione allo studio
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Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
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Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- IRB-25-0709
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
Our data will be securely managed by members of our research team and will not be shared with members outside of our research team. Findings from our research will be summarized and shared such that participants are not individually identifiable. Should other collaborators desire to access our data, they will need to be aligned with the goals of our research and added and approved to our IRB protocol.
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .