Feasibility, Acceptability and Preliminary Clinical Outcome Signals Following a Digital Things You Do (TYD) Intervention in Primary Care: A Single-case Study
22. juli 2026 oppdatert av: 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.
Studieoversikt
Status
Fullført
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
14
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Varberg, Sverige
- Halland Primary Care
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Ikke-randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Annen: 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.
Andre navn:
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Annen: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Daily Mood Assessment
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Internet Evaluation and Utility Questionnaire (IEUQ)
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Anne H Berman, MSc, PhD, Uppsala University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
25. oktober 2025
Primær fullføring (Faktiske)
2. februar 2026
Studiet fullført (Faktiske)
31. mars 2026
Datoer for studieregistrering
Først innsendt
13. juli 2026
Først innsendt som oppfylte QC-kriteriene
22. juli 2026
Først lagt ut (Faktiske)
23. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
23. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
22. juli 2026
Sist bekreftet
1. juli 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-04878-01
- 2024-01873 (Annet stipend/finansieringsnummer: FORTE)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
UBESLUTTE
IPD-planbeskrivelse
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.
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