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Feasibility, Acceptability and Preliminary Clinical Outcome Signals Following a Digital Things You Do (TYD) Intervention in Primary Care: A Single-case Study

22. července 2026 aktualizováno: Anne H Berman, Uppsala University

Meeting Psychiatric Challenges in Primary Care Via Low-Threshold Digital Mental Health Interventions

This study evaluates potential help for mild to moderate psychological distress in primary care patients. The study offers a choice between two interventions, both offered online (in a digital format). One intervention targets five key daily behaviors found to reduce depression and anxiety in earlier studies. The second intervention, also found to reduce depression and anxiety in earlier studies, targets relationship issues through a forgiveness process.

The study is designed as a single-case study where each individual is followed in detail over a period of 10 weeks, with a one-week follow-up after 3 months. In the first two weeks, participants fill in daily mood assessments and answer a brief questionnaire once every week. Then, participants start the intervention they chose, and continue to fill in the same questions, both daily and once a week. The intervention phase lasts five weeks. Then participants continue to fill in the daily mood assessments and weekly questionnaire for three more weeks. After three months, participants do the daily and weekly assessments for one final week.

The results will be analyzed at the individual level and, if enough participants join, at a group level. No one will be personally identified in any way when results are reported.

The study is exploratory, meaning that the researchers want to know which interventions participants tend to choose most often, whether the interventions appeal to participants, how long they stay in the study, and how they use the intervention material. The researchers also want to know what changes participants think would be needed for future studies or implementation in primary care clinics.

Přehled studie

Postavení

Dokončeno

Podmínky

Typ studie

Intervenční

Zápis (Aktuální)

14

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

      • Varberg, Švédsko
        • Halland Primary Care

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

Inclusion Criteria:

  • Mild to moderate self-reported depression (score of <20 and >4 on the PHQ-9) AND/OR
  • Mild to moderate anxiety symptoms (score of >4 on the GAD-7)

Exclusion Criteria:

  • Ongoing psychological treatment
  • Recently initiated medication for regulating mood or emotions (past 3 weeks)
  • Scores of >19 or <5 on the PHQ-9
  • Scores of <5 on the GAD-7
  • Current suicidal thoughts or plans according to item 9 of the PHQ-9.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: Nerandomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Jiný: TYD choice
Choosing Things You Do (TYD) means option to participate in a mini-course online and then aim to perform the five TYD behaviors as much as possible. More specifically, the TYD intervention begins with three brief modules covering psychoeducational content regarding mental health, the TYD framework and the identification of personally relevant behaviors. The intervention then entails completing app-based daily tasks, including a daily activity diary, daily inspirational notes and weekly reflection prompts.
The TYD intervention begins with three brief modules covering psychoeducational content regarding mental health, the TYD framework and the identification of personally relevant behaviors. The intervention then entails completing app-based daily tasks, including a daily activity diary, daily inspirational notes and weekly reflection prompts. The length of the intervention period is set at five weeks in this study.
Ostatní jména:
  • Big Five
Jiný: Choice of REACH intervention
Participants choose the REACH forgiveness of others intervention. This choice means completing an online workbook with 12 lessons focusing in sequence on the five REACH components.
This choice means completing an online workbook with 12 lessons focusing in sequence on the five REACH components, intended to alleviate feelings associated with a past hurt that the participant has experienced, usually from another person.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Daily Mood Assessment
Časové okno: Daily during 2-week baseline phase/daily during 5-week intervention period/daily during 3-week post-intervention period/daily during one-week follow-up at 14 weeks after study inclusion.
The main repeated outcome is a daily mood composite derived from six questions developed specifically for this study (daytime mood, interest or pleasure in activities, sleep, energy, anxiety level and anxiety control) rated on 1-10 visual analogue scales (VAS), with higher scores on the scale indicating better mood. Specific questions were developed for this study and are available on request.
Daily during 2-week baseline phase/daily during 5-week intervention period/daily during 3-week post-intervention period/daily during one-week follow-up at 14 weeks after study inclusion.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Patient Health Questionnaire-9 (PHQ-9)
Časové okno: Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
Score range 1-27, higher values mean worse outcomes.
Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
Generalized Anxiety Disorder (GAD-7)
Časové okno: Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
Score range 1-21, higher values mean worse outcomes
Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
5-item World Health Organization Well-Being Index (WHO-5)
Časové okno: Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
Score range 20-100, higher values mean better outcomes
Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
Trait Forgivingness Scale (TFS)
Časové okno: Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
The 10-item TFS measures the personality trait of being a forgiving person (Berry' Worthington' O'Connor' Parrott' & Wade' 2005). Score range 5-50 (items 1, 3, 6, 7 and 8 are reversed). Higher scores mean higher levels of forgivingness.
Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
Things You Do (TYD) Questionnaire
Časové okno: Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.
The TYD-15 questionnaire includes 15 items that measure the frequency of TYD behaviors during the past week. Participants respond on a five-point Likert scale from 'Not at all' (0) to 'Every day' (4), with a score range of 0-60. Higher scores indicate greater engagement in TYD behaviors. TYD-15 shows good internal consistency with Cronbach's alpha between 0.87 and 0.90 (Bisby et al, 2024).
Weekly during 2-week baseline phase/weekly during 5-week intervention period/weekly during 3-week post-intervention period/once during one-week follow-up at 14 weeks after study inclusion.

Další výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Internet Evaluation and Utility Questionnaire (IEUQ)
Časové okno: Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
The IEUQ is a "16-item measure designed to assess usability, likeability, usefulness, understandability, and convenience of the Internet intervention." (Thorndike et al 2008, p. 6). Score range of 0-64; higher scores mean better intervention utility. Reference: Thorndike FP, Saylor DK, Bailey ET, Gonder-Frederick L, Morin CM, Ritterband LM. Development and Perceived Utility and Impact of an Internet Intervention for Insomnia. E J Appl Psychol. 2008;4(2):32-42.
Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
Additional intervention experiences
Časové okno: Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
Study-developed question: How would you describe your overall experience with the intervention, including any specific benefits, challenges or outcomes?
Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Spolupracovníci

Vyšetřovatelé

  • Vrchní vyšetřovatel: Anne H Berman, MSc, PhD, Uppsala University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

25. října 2025

Primární dokončení (Aktuální)

2. února 2026

Dokončení studie (Aktuální)

31. března 2026

Termíny zápisu do studia

První předloženo

13. července 2026

První předloženo, které splnilo kritéria kontroly kvality

22. července 2026

První zveřejněno (Aktuální)

23. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

23. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

22. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Další identifikační čísla studie

  • 2025-04878-01
  • 2024-01873 (Jiné číslo grantu/financování: FORTE)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NEROZHODNÝ

Popis plánu IPD

The data set contains sensitive personal health data from a small regional sample and is not publicly available. De-identified data may be available from the corresponding author on reasonable request, subject to applicable ethical, legal and data-protection requirements.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

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Klinické studie na Things You Do (TYD)

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