Feasibility, Acceptability and Preliminary Clinical Outcome Signals Following a Digital Things You Do (TYD) Intervention in Primary Care: A Single-case Study

NCT07721870 | Completed

• 2 other identifiers: 2025-04878-012024-01873
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Anxiety; Depression

Keywords

Digital intervention; Primary care; Pilot study; Acceptability; Adherence; Feasibility; Retention; Single-case experimental design

Outcome Measures

Primary Outcomes (1)

• Daily Mood Assessment

  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.

Secondary Outcomes (5)

• Patient Health Questionnaire-9 (PHQ-9)

  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)

  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)

  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)

  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

  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.

Other Outcomes (2)

• Internet Evaluation and Utility Questionnaire (IEUQ)

  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

  Completed at the end of individual participant data collection; i.e., prior to 14-week follow-up in the event of participant attrition.

Study Arms (2)

TYD choice

OTHER

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.

Behavioral: Things You Do (TYD)

Choice of REACH intervention

OTHER

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.

Behavioral: REACH

Interventions

Things You Do (TYD) BEHAVIORAL

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.

Also known as: Big Five

TYD choice

REACH BEHAVIORAL

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.

Choice of REACH intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Uppsala University: lead
• Forte: collaborator

Study Sites (1)

Halland Primary Care

Varberg, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders; Depression

Condition Hierarchy (Ancestors)

Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Anne H Berman, MSc, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 13, 2026
• First Posted: July 23, 2026
• Study Start: October 25, 2025
• Primary Completion: February 2, 2026
• Study Completion: March 31, 2026
• Last Updated: July 23, 2026

Record last verified: 2026-07

Locations

SE (1)