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| ID | Type | Description | Link |
|---|---|---|---|
| PZ00P1_208742 | Other Grant/Funding Number | Swiss National Science Foundation (SNSF) |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Social Support JITAI triggered based on Vulnerability | Experimental | The intervention will be delivered when at least one vulnerability indicator reaches a score of ≥ 5 on a 7-point scale. Original german wording can be found in on the repository of the Open Science Framework (OSF) at https://osf.io/r8mks. Vulnerability indicators Negative affect (single item): "To what extent are you currently experiencing negative emotions?" 7-point Likert-Scale (1 = "I do not experience any negative emotions" to 7 = "I experience very strong negative emotions") Stress (single item; self-developed): "I'm feeling stressed at the moment." 7-point Likert-Scale (1 = "strongly disagree" to 7 = "strongly agree") Loneliness (single item): "I feel lonely at the moment." 7-point Likert-Scale, as above Rumination (single item): "I notice that I keep having the same negative thoughts over and over again." 7-point Likert-Scale, as above Listlessness (single item; self-developed): "I don't feel like doing anything right now." 7-point Likert-Scale, as above |
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| Social Support JITAI triggered based on Vulnerability and Receptivity | Experimental | The intervention will be delivered when the vulnerability criterion (≥ 5) is met and the respondent answers "yes" to the receptivity item. The content of this intervention condition is slightly different to the other ones (conditions 1 + 3) as it allows for postponement of the intervention when one is not receptive. Original german wording can be found in on the repository of the Open Science Framework (OSF) at https://osf.io/r8mks. Receptivity (single item; self-developed) "I am currently open to receiving support from this app which could help me to feel better." 7-point Likert scale (1 = "strongly disagree" to 7 = "strongly agree") |
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| Social Support JITAI triggered based on Support Need | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Social Support Just-in-Time Adaptive Intervention | Behavioral | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Depressive Symptoms | 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") | Measured in the evening of study days 1-21 |
| Received Social Support | "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.)." | Measured in the evening of study days 1-21 |
| Measure | Description | Time Frame |
|---|---|---|
| Loneliness | "I felt lonely today" (5-point Likert scale with 1 = "strongly disagree" to 5 = "strongly agree") | Measured in the evening of study days 1-21 |
| Perceived Social Support | (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") |
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Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Zurich | Recruiting | Zurich | Canton of Zurich | 8050 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11058490 | Background | Hirschfeld RM, Williams JB, Spitzer RL, Calabrese JR, Flynn L, Keck PE Jr, Lewis L, McElroy SL, Post RM, Rapport DJ, Russell JM, Sachs GS, Zajecka J. Development and validation of a screening instrument for bipolar spectrum disorder: the Mood Disorder Questionnaire. Am J Psychiatry. 2000 Nov;157(11):1873-5. doi: 10.1176/appi.ajp.157.11.1873. | |
| 16832698 |
| Label | URL |
|---|---|
| Open Science Framework (OSF) Repository including OSF preregistration | View source |
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De-identified and anonmyized individual participant data that underlie the results reported in this study, will be made available on an Open Science Framework (OSF) repository to researchers for the purpose of reproducing the reported analyses.
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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.
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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.
The intervention will be delivered when the participants indicate "yes" in the support need item. Original german wording can be found in on the repository of the Open Science Framework (OSF) at https://osf.io/r8mks. Support need item (single item; self-developed) "Would it help you right now to talk to someone about how you're feeling?" (Yes / No) |
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| Control Condition | No Intervention | No interventions are delivered on the respective study days |
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| Measured in the evening of study days 1-21 |
| Kuhner C, Burger C, Keller F, Hautzinger M. [Reliability and validity of the Revised Beck Depression Inventory (BDI-II). Results from German samples]. Nervenarzt. 2007 Jun;78(6):651-6. doi: 10.1007/s00115-006-2098-7. German. |
| 25499982 | Background | Kliem S, Mossle T, Rehbein F, Hellmann DF, Zenger M, Brahler E. A brief form of the Perceived Social Support Questionnaire (F-SozU) was developed, validated, and standardized. J Clin Epidemiol. 2015 May;68(5):551-62. doi: 10.1016/j.jclinepi.2014.11.003. Epub 2014 Nov 13. |
| 38356901 | Background | Fried EI, Proppert RKK, Rieble CL. Building an Early Warning System for Depression: Rationale, Objectives, and Methods of the WARN-D Study. Clin Psychol Eur. 2023 Sep 29;5(3):e10075. doi: 10.32872/cpe.10075. eCollection 2023 Sep. |
| 33536986 | Background | Berli C, Schwaninger P, Scholz U. "We Feel Good": Daily Support Provision, Health Behavior, and Well-Being in Romantic Couples. Front Psychol. 2021 Jan 18;11:622492. doi: 10.3389/fpsyg.2020.622492. eCollection 2020. |
| 35246009 | Background | Mund M, Maes M, Drewke PM, Gutzeit A, Jaki I, Qualter P. Would the Real Loneliness Please Stand Up? The Validity of Loneliness Scores and the Reliability of Single-Item Scores. Assessment. 2023 Jun;30(4):1226-1248. doi: 10.1177/10731911221077227. Epub 2022 Mar 4. |
| 11138764 | Background | Bolger N, Zuckerman A, Kessler RC. Invisible support and adjustment to stress. J Pers Soc Psychol. 2000 Dec;79(6):953-61. doi: 10.1037//0022-3514.79.6.953. |
| 15820844 | Background | Lowe B, Kroenke K, Grafe K. Detecting and monitoring depression with a two-item questionnaire (PHQ-2). J Psychosom Res. 2005 Feb;58(2):163-71. doi: 10.1016/j.jpsychores.2004.09.006. |
| 36480406 | Background | Cloos L, Ceulemans E, Kuppens P. Development, validation, and comparison of self-report measures for positive and negative affect in intensive longitudinal research. Psychol Assess. 2023 Mar;35(3):189-204. doi: 10.1037/pas0001200. Epub 2022 Dec 8. |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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