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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 lipca 2026 zaktualizowane przez: 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.

Przegląd badań

Status

Zakończony

Warunki

Interwencja / Leczenie

Typ studiów

Interwencyjne

Zapisy (Rzeczywisty)

14

Faza

  • Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

  • Szwecja
      • Varberg, Szwecja
        • Halland Primary Care

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

  • Dorosły
  • Starszy dorosły

Akceptuje zdrowych ochotników

Nie

Opis

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.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Leczenie podtrzymujące
  • Przydział: Nielosowe
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Brak (otwarta etykieta)

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Inny: 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.
Behawioralne: Things You Do (TYD)
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.
Inne nazwy:
  • Big Five
Inny: 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.
Behawioralne: REACH
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 mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Daily Mood Assessment
Ramy czasowe: 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.

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Patient Health Questionnaire-9 (PHQ-9)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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)
Ramy czasowe: 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
Ramy czasowe: 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.

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Internet Evaluation and Utility Questionnaire (IEUQ)
Ramy czasowe: 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
Ramy czasowe: 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.

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Uppsala University

Współpracownicy

Forte

Śledczy

  • Główny śledczy: Anne H Berman, MSc, PhD, Uppsala University

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

25 października 2025

Zakończenie podstawowe (Rzeczywisty)

2 lutego 2026

Ukończenie studiów (Rzeczywisty)

31 marca 2026

Daty rejestracji na studia

Pierwszy przesłany

13 lipca 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

22 lipca 2026

Pierwszy wysłany (Rzeczywisty)

23 lipca 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 lipca 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

22 lipca 2026

Ostatnia weryfikacja

1 lipca 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • 2025-04878-01
  • 2024-01873 (Inny numer grantu/finansowania: FORTE)

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIEZDECYDOWANY

Opis planu 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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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