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

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.

Study Overview

• Status: Completed
• Conditions: Depression; Anxiety
• Intervention / Treatment: Behavioral: Things You Do (TYD); Behavioral: REACH

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Varberg, Sweden
    • Halland Primary Care

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Behavioral: 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.; Other Names: Big Five
Other: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-9 (PHQ-9)	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)	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)	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)	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	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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Internet Evaluation and Utility Questionnaire (IEUQ)	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	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.

Collaborators and Investigators

• Sponsor: Uppsala University
• Collaborators: Forte
• Investigators: Principal Investigator: Anne H Berman, MSc, PhD, Uppsala University

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2025
• Primary Completion (Actual): February 2, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: July 13, 2026
• First Submitted That Met QC Criteria: July 22, 2026
• First Posted (Actual): July 23, 2026

Study Record Updates

• Last Update Posted (Actual): July 23, 2026
• Last Update Submitted That Met QC Criteria: July 22, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Adherence; Feasibility; Primary care; Retention; Acceptability; Pilot study; Digital intervention; Single-case experimental design
• Additional Relevant MeSH Terms: Mental Disorders; Behavioral Symptoms; Behavior; Anxiety Disorders; Depression
• Other Study ID Numbers: 2025-04878-01; 2024-01873 (Other Grant/Funding Number: FORTE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No