Feasibility, Acceptability and Preliminary Clinical Outcome Signals Following a Digital Things You Do (TYD) Intervention in Primary Care: A Single-case Study
22 de julho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Concluído
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
14
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Varberg, Suécia
- Halland Primary Care
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Cuidados de suporte
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Outro: 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.
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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.
Outros nomes:
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Outro: 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.
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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.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Daily Mood Assessment
Prazo: 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.
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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.
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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.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Prazo: 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.
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Score range 1-27, higher values mean worse outcomes.
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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.
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Generalized Anxiety Disorder (GAD-7)
Prazo: 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.
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Score range 1-21, higher values mean worse outcomes
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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.
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5-item World Health Organization Well-Being Index (WHO-5)
Prazo: 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.
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Score range 20-100, higher values mean better outcomes
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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.
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Trait Forgivingness Scale (TFS)
Prazo: 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.
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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.
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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.
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Things You Do (TYD) Questionnaire
Prazo: 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.
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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).
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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.
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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
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Internet Evaluation and Utility Questionnaire (IEUQ)
Prazo: Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
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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.
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Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
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Additional intervention experiences
Prazo: Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
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Study-developed question: How would you describe your overall experience with the intervention, including any specific benefits, challenges or outcomes?
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Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anne H Berman, MSc, PhD, Uppsala University
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
25 de outubro de 2025
Conclusão Primária (Real)
2 de fevereiro de 2026
Conclusão do estudo (Real)
31 de março de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
13 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
22 de julho de 2026
Primeira postagem (Real)
23 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
23 de julho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
22 de julho de 2026
Última verificação
1 de julho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-04878-01
- 2024-01873 (Número de outro subsídio/financiamento: FORTE)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
INDECISO
Descrição do plano 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.
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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