Clinical trial NCT06856668: A Megastudy of Single-Session Interventions for Depression
Official title: A Megastudy of Single-Session Interventions to Challenge Depression in American Adults
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Depression - Major Depressive Disorder
Keywords: single-session intervention
depression
megastudy
digital mental health intervention
experiment
randomized clinical trial
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2025-03-04
Enrollment: 7500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This project aims to learn if new kinds of digital single-session interventions (SSIs) for depression could be effective for American adults. Many existing SSIs are delivered in a simple text-based format. However, it might be that different kinds of SSIs (in terms of both content and style) also have potential for scalable impact. Specifically, this study will investigate the effectiveness of 11 innovative SSIs by comparing them to a passive control and to an existing SSI with established efficacy.


Eligibility criteria: Inclusion criteria:

* At least 18 years old
* Able to read and write fluently in English
* Have enough access to the internet to complete two sessions over four weeks
* Score at least 10 on the PHQ-9 screen (suggesting moderate depression; Kroenke et al., 2001)
* Pass the bot check during the screening survey

All participants who are randomized to an experimental condition (and therefore completed all baseline measures) will be included in analyses, except for participants who indicate at the end of either the baseline or week 4 session that they did not participate in the study seriously. Researchers will only keep data from the first survey session a participant begins.

Primary outcomes:
measure: Change in Patient Health Questionnaire-9 at week 4 (PHQ-9; Kroenke et al., 2001)
timeFrame: Baseline to week 4
Secondary outcomes:
measure: Change in Beck Hopelessness Scale at immediate post-intervention (BHS-4; Perczel Forintos et al., 2013)
timeFrame: Baseline to immediate post-intervention
measure: Change in Beck Hopelessness Scale at week 4 (BHS-4; Perczel Forintos et al., 2013)
timeFrame: Baseline to week 4
measure: Change in Pathways Subscale of the State Hope Scale at immediate post-intervention (Snyder et al., 1996)
timeFrame: Baseline to immediate post-intervention
measure: Change in Pathways Subscale of the State Hope Scale at week 4 (Snyder et al., 1996)
timeFrame: Baseline to week 4
measure: Change in Readiness for Change at immediate post-intervention
timeFrame: Baseline to immediate post-intervention
measure: Change in Readiness for Change at week 4
timeFrame: Baseline to week 4
measure: Change in Depression Expectancies for Change at immediate post-intervention (Eddington et al., 2014)
timeFrame: Baseline to immediate post-intervention
measure: Change in Depression Expectancies for Change at week 4 (Eddington et al., 2014)
timeFrame: Baseline to week 4
measure: Change in Frequency of Actions and Thoughts Scale at immediate post-intervention (FATS; Terides et al., 2016).
timeFrame: Baseline to immediate post-intervention
measure: Change in Frequency of Actions and Thoughts Scale at week 4 (FATS; Terides et al., 2016).
timeFrame: Baseline to week 4
measure: Credibility and Expectancy Questionnaire at immediate post-intervention (CEQ; Devilly & Borkovec; 2000)
timeFrame: immediate post-intervention
measure: Insight Experience at immediate post-intervention
timeFrame: immediate post-intervention
measure: Insight Experience at week four
timeFrame: week 4
measure: Star rating at immediate post-intervention
timeFrame: immediate post-intervention
measure: Star rating at week 4
timeFrame: week 4
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Medical Social Sciences
state: Illinois
Study officials:
References:
citation: Eddington KM, Dozois DJ, Backs-Dermott BJ. Evaluation of the internal consistency, factor structure, and validity of the Depression Change Expectancy Scale. Assessment. 2014 Oct;21(5):607-17. doi: 10.1177/1073191113517929. Epub 2013 Dec 30.
citation: Terides MD, Dear BF, Karin E, Jones MP, Gandy M, Fogliati VJ, Kayrouz R, Staples LG, Titov N. The frequency of actions and thoughts scale: development and psychometric validation of a measure of adaptive behaviours and cognitions. Cogn Behav Ther. 2016 Apr;45(3):196-216. doi: 10.1080/16506073.2016.1149876. Epub 2016 Feb 29.
citation: Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.
citation: Perczel Forintos D, Rozsa S, Pilling J, Kopp M. Proposal for a short version of the Beck Hopelessness Scale based on a national representative survey in Hungary. Community Ment Health J. 2013 Dec;49(6):822-30. doi: 10.1007/s10597-013-9619-1. Epub 2013 Jun 12.
citation: Laukkonen RE, Kaveladze BT, Tangen JM, Schooler JW. The dark side of Eureka: Artificially induced Aha moments make facts feel true. Cognition. 2020 Mar;196:104122. doi: 10.1016/j.cognition.2019.104122. Epub 2019 Nov 20.
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Goodman E, Adler NE, Kawachi I, Frazier AL, Huang B, Colditz GA. Adolescents' perceptions of social status: development and evaluation of a new indicator. Pediatrics. 2001 Aug;108(2):E31. doi: 10.1542/peds.108.2.e31.
citation: Devilly GJ, Borkovec TD. Psychometric properties of the credibility/expectancy questionnaire. J Behav Ther Exp Psychiatry. 2000 Jun;31(2):73-86. doi: 10.1016/s0005-7916(00)00012-4.
citation: Beck AT, Weissman A, Lester D, Trexler L. The measurement of pessimism: the hopelessness scale. J Consult Clin Psychol. 1974 Dec;42(6):861-5. doi: 10.1037/h0037562. No abstract available.