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 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
14
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Varberg, Sverige
- Halland Primary Care
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Övrig: 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.
Andra namn:
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Övrig: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Daily Mood Assessment
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Patient Health Questionnaire-9 (PHQ-9)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Internet Evaluation and Utility Questionnaire (IEUQ)
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Anne H Berman, MSc, PhD, Uppsala University
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
25 oktober 2025
Primärt slutförande (Faktisk)
2 februari 2026
Avslutad studie (Faktisk)
31 mars 2026
Studieregistreringsdatum
Först inskickad
13 juli 2026
Först inskickad som uppfyllde QC-kriterierna
22 juli 2026
Första postat (Faktisk)
23 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 juli 2026
Senast verifierad
1 juli 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-04878-01
- 2024-01873 (Annat bidrag/finansieringsnummer: FORTE)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
OBESLUTSAM
IPD-planbeskrivning
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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