- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07471529
Activating Social Resources in Psychotherapy-Seeking Individuals: Effectiveness and Timing of a Social Support Just-in-Time Adaptive Intervention
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Canton of Zurich
-
Zurich, Canton of Zurich, Switzerland, 8050
- Recruiting
- University of Zurich
-
Contact:
- Timon Elmer, PhD
- Phone Number: +41 44 635 72 65
- Email: timon.elmer@uzh.ch
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Social Support JITAI triggered based on Vulnerability
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 |
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
|
|
Experimental: Social Support JITAI triggered based on Vulnerability and Receptivity
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") |
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
|
|
Experimental: Social Support JITAI triggered based on Support Need
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) |
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
|
|
No Intervention: Control Condition
No interventions are delivered on the respective study days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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") |
Measured in the evening of study days 1-21
|
|
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.)." |
Measured in the evening of study days 1-21
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Loneliness
Time Frame: 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")
|
Measured in the evening of study days 1-21
|
|
Perceived Social Support
Time Frame: 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")
|
Measured in the evening of study days 1-21
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 25.09.06
- PZ00P1_208742 (Other Grant/Funding Number: Swiss National Science Foundation (SNSF))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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