Menu
Recruiting NCT07471529

Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention

No phase Interventional Loneliness Social Support Depressive Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Social Support Just-in-Time Adaptive Intervention.
Who it may be relevant to
Registry conditions: Loneliness, Social Support, Depressive Symptoms. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Behavioral Social 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, solut

Primary outcome measures

  • Depressive Symptoms [Time frame: Measured in the evening of study days 1-21]
  • Received Social Support [Time frame: Measured in the evening of study days 1-21]
Secondary outcome measures (2)
  • Loneliness [Time frame: Measured in the evening of study days 1-21]
  • Perceived Social Support [Time frame: Measured in the evening of study days 1-21]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Other

Study locations

Switzerland · 1 center
  • University of Zurich — Zurich

Publications

  • 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. PMID 11058490
  • 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. PMID 16832698
  • 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. PMID 25499982
  • 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. PMID 38356901
  • 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. PMID 33536986
  • 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. PMID 35246009
  • 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. PMID 11138764
  • 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. PMID 15820844

Identifiers

NCT: NCT07471529 · 25.09.06 · PZ00P1_208742

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗