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

Uppsala University14 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

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.

REACHBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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

Patient Health Questionnaire-9 (PHQ-9)

Score range 1-27, higher values mean worse outcomes.

Time frame: 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

5-item World Health Organization Well-Being Index (WHO-5)

Score range 20-100, higher values mean better outcomes

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.

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).