LonelinessNCT07471529

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

A study testing Social Support Just-in-Time Adaptive Intervention in people with Loneliness and Social Support, run by University of Zurich at 1 site in Switzerland.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Loneliness, Social Support, Depressive Symptoms
What is being tested?: Social Support Just-in-Time Adaptive Intervention
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteSwitzerland
Study dates: 22 Apr 2026to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Switzerland1 site, 1 recruiting

University of Zurich
Zurich, Canton of Zurich, 8050
Timon Elmer, PhD, +41 44 635 72 65, timon.elmer@uzh.ch
Recruiting

Other trials in Switzerland

About this study

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.

Conditions: Loneliness, Social Support, Depressive Symptoms
Being tested: Social Support Just-in-Time Adaptive Intervention
Keywords: Social Support, Loneliness, Just-in-Time Adaptive Intervention, JITAI, Ecological Momentary Intervention, Depressive Symptoms
Medical subject headings: Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Social Support Just-in-Time Adaptive InterventionBehavioural
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

Study groups in NCT07471529
Study group	Role	What they receive
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 Receives: Behavioral: Social Support Just-in-Time Adaptive Intervention
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") Receives: Behavioral: Social Support Just-in-Time Adaptive Intervention
Social Support JITAI triggered based on Support Need	Experimental	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) Receives: Behavioral: Social Support Just-in-Time Adaptive Intervention
Control Condition	No intervention	No interventions are delivered on the respective study days

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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: Measured in the evening of study days 1-21

Secondary outcomes (2)

Loneliness
"I felt lonely today" (5-point Likert scale with 1 = "strongly disagree" to 5 = "strongly agree")
Measured: 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")
Measured: Measured in the evening of study days 1-21

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Apr 2026Dec 2026

First posted13 Mar 2026
Study start22 Apr 2026
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (9)Papers the sponsor has linked to this study.
Other trials for LonelinessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
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.
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 120 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07471529
Sponsor's protocol ID: 25.09.06
Other IDs: PZ00P1_208742
Status last verified: Apr 2026
First submitted: 3 Mar 2026
Last updated: 30 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 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.
PubMed 15820844
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.
PubMed 36480406

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention
ClinicalTrials.gov ID: NCT07471529
Acronym / sponsor ID: 25.09.06
Conditions: Loneliness, Social Support, Depressive Symptoms
Keywords: Social Support, Loneliness, Just-in-Time Adaptive Intervention, JITAI, Ecological Momentary Intervention, Depressive Symptoms
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 120 participants (estimated)
Lead sponsor: University of ZurichUniversity, hospital or other
Study start: 22 Apr 2026 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 13 Mar 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4
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.

Arm	Type	Receives
Social Support JITAI triggered based on Vulnerability	Experimental	Behavioral: Social Support Just-in-Time Adaptive InterventionThe 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
Social Support JITAI triggered based on Vulnerability and Receptivity	Experimental	Behavioral: Social Support Just-in-Time Adaptive InterventionThe 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")
Social Support JITAI triggered based on Support Need	Experimental	Behavioral: Social Support Just-in-Time Adaptive InterventionThe 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)
Control Condition	No intervention	–No interventions are delivered on the respective study days

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Social Support Just-in-Time Adaptive InterventionThe 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	Behavioural	Social Support JITAI triggered based on Support Need, Social Support JITAI triggered based on Vulnerability, Social Support JITAI triggered based on Vulnerability and Receptivity

Primary outcome

Depressive Symptoms
Time frame: 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
Time frame: 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.)."

2 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
Background: PubMed 11058490Hirschfeld 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.
Background: PubMed 16832698Kuhner 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.
Background: PubMed 25499982Kliem 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.
Background: PubMed 38356901Fried 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.
Background: PubMed 33536986Berli 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.
Background: PubMed 35246009Mund 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.
Background: PubMed 11138764Bolger 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.
Background: PubMed 15820844Lowe 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.
Background: PubMed 36480406Cloos 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.
Open Science Framework (OSF) Repository including OSF preregistrationLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

University of Zurich

Zurich, Switzerland

+41 44 635 72 65

timon.elmer@uzh.ch

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Social Support Just-in-Time Adaptive Intervention in people with Loneliness and Social Support, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Depressive Symptoms (time frame: Measured in the evening of study days 1-21). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07471529, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.