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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 juillet 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Type d'étude

Interventionnel

Inscription (Réel)

14

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Suède
      • Varberg, Suède
        • Halland Primary Care

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: 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.
Comportemental: 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.
Autres noms:
  • Big Five
Autre: 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.
Comportemental: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Daily Mood Assessment
Délai: 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.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient Health Questionnaire-9 (PHQ-9)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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.

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Internet Evaluation and Utility Questionnaire (IEUQ)
Délai: 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
Délai: 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.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Uppsala University

Collaborateurs

Forte

Les enquêteurs

  • Chercheur principal: Anne H Berman, MSc, PhD, Uppsala University

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

25 octobre 2025

Achèvement primaire (Réel)

2 février 2026

Achèvement de l'étude (Réel)

31 mars 2026

Dates d'inscription aux études

Première soumission

13 juillet 2026

Première soumission répondant aux critères de contrôle qualité

22 juillet 2026

Première publication (Réel)

23 juillet 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 juillet 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 juillet 2026

Dernière vérification

1 juillet 2026

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 2025-04878-01
  • 2024-01873 (Autre subvention/numéro de financement: FORTE)

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

INDÉCIS

Description du régime 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.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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