Depressive Symptoms, Loneliness, Social Support
Conditions
Keywords
Social Support, Loneliness, Just-in-Time Adaptive Intervention, JITAI, Ecological Momentary Intervention, Depressive Symptoms
Brief summary
This study evaluates a Just-In-Time Adaptive Intervention (JITAI) aiming to foster social support processes for adults with elevated depressive symptoms awaiting outpatient psychotherapy. Utilizing a daily-level micro-randomized trial (MRT) design conducted over 21 days, participants are assessed six times daily. Participants are randomized across four conditions: (1) vulnerability-triggered, (2) vulnerability and receptivity-triggered, (3) support-need-triggered, and (4) a no-intervention control. The primary objective of this study is to evaluate the effectiveness of the JITAI in reducing daily depressive symptoms and increasing received social support (primary outcomes), as well as reducing daily loneliness and enhancing perceived social support (secondary outcomes). Furthermore, the study aims to compare the relative efficacy of three distinct triggering strategies to identify the most effective timing for intervention delivery.
Interventions
BEHAVIORALSocial Support Just-in-Time Adaptive Intervention
The intervention is a smartphone-based system designed to encourage the activation of social support networks during critical moments. Triggers are based on real-time Ecological Momentary Assessment (EMA) data. When a condition is met, the app prompts participants to identify a specific type of support needed and a person from their social network to contact. It then provides one of three evidence-based recommendations to facilitate effective support-seeking behavior (direct communication, solution-focused discussion, and reframing the situation). If no social contact is available, the app suggests alternative self-help activities. Detailed information can be found on the OSF project page: https://osf.io/4e8gz
Sponsors
University of Zurich
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Due to the micro-randomized trial design, randomization occurs automatically and daily within the smartphone application. Consequently, participants are masked as they are not informed of which triggering strategy is active on any given day. Furthermore, because the intervention is delivered entirely through the app without human mediation, study personnel who interact with participants remain unaware of the specific experimental allocations at any given timepoint.
Intervention model description
On each study day, participants will be randomly assigned to one of three experimental conditions or the control condition (ratio 1:1:1:1; micro-randomized trial design). The four conditions are described further below. Given the within-person randomization, each participant goes through all conditions multiple times. This evaluation is conducted through a 21-day intervention phase where participants are assessed six times daily via Ecological Momentary Assessments (EMA). The first five EMA questionnaires occur at pre-specified time windows throughout the day to capture vulnerability, receptivity, and support need and potentially present the social support JITAI (depending on the condition and the EMA responses). The sixth EMA is a specific evening questionnaire and measures the outcome variables.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* indicating to seek outpatient psychotherapy * elevated levels of self-reported depressive symptoms (Beck Depression Inventory-II (BDI) score \> 13 (out of 63); Kühner et al., 2007) * owning a smartphone * signing the informed consent form
Exclusion criteria
* first session for outpatient psychotherapy is scheduled within four weeks * suicidal ideation (values \> 2 in BDI item 9) * presence of manic symptoms (Mood Disorder Questionnaire (MDQ) score \> 7), - shift work * age below 18 or above 70
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Depressive Symptoms | Measured in the evening of study days 1-21 | PHQ-2, adapted for daily measurement "Today, I felt down, depressed, or hopeless." "Today, I had little interest or pleasure in my activities." (7-point Likert scale with 1 = "strongly disagree" to 7 = "strongly agree") |
| Received Social Support | Measured in the evening of study days 1-21 | "Today, I received emotional support from others." "Today, I received practical help from others." (7-point Likert scale with 1 = "strongly disagree" to 7 = "strongly agree") Before that the participants were shown a definition of emotional and practical support: "Support can be emotional (e.g., listening, offering comfort, encouraging, etc.) or involve practical assistance (e.g., giving advice, gathering information, running errands, etc.)." |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Loneliness | Measured in the evening of study days 1-21 | "I felt lonely today" (5-point Likert scale with 1 = "strongly disagree" to 5 = "strongly agree") |
| Perceived Social Support | Measured in the evening of study days 1-21 | (i) "If I had fallen ill today, I could have asked friends/relatives to take care of important things for me without hesitation." (ii) "If I were feeling very depressed right now, I would know who I could easily turn to." (7-point Likert scale with 1 = "strongly disagree" to 7 = "strongly agree") |
Countries
Switzerland
Outcome results
None listed