A Megastudy of Single-Session Interventions for Depression

NCT ID: NCT06856668

Last Updated: 2025-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-11

Study Completion Date

2025-06-24

Brief Summary

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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.

Detailed Description

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Conditions

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Depression - Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All intervention conditions will be allocated approximately the same number of participants, while the control condition will be allocated three times that number.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Passive control (All About Trout)

The passive control condition aims to hold one's attention for 8-10 minutes without influencing depressive symptoms or mood (a three-minute video, multiple-choice questions, two-minute reading passage, three-minute writing exercise, all about trout).

Group Type OTHER

All about Trout

Intervention Type BEHAVIORAL

An 8-10 minute educational program with information and interactive exercises about trout fish. Intended to capture one's attention and require some effort, while minimizing influence on depressive symptoms.

Behavioral Activation (Action Brings Change Project)

A behavioral activation SSI where users learn about negative thought spirals, share advice with an imagined peer, and create an "action plan" of helpful activities to engage in in the future.

Group Type ACTIVE_COMPARATOR

Behavioral Activation (Action Brings Change Project 10-Minute Version)

Intervention Type BEHAVIORAL

A behavioral activation SSI where users learn about negative thought spirals, give advice to an imagined peer, then create an "action plan" of helpful activities to do in the near future. This is a shorter version of the original 15-minute Action Brings Change SSI.

SSI 1: Mindful Acceptance

A clinical psychologist explains a few ways to use mindful acceptance to deal with difficult thoughts and feelings.

Group Type EXPERIMENTAL

Mindful Acceptance

Intervention Type BEHAVIORAL

A clinical psychologist explains a few ways to use mindful acceptance to deal with difficult thoughts and feelings.

SSI 2: Moral Elevation

Users learn about moral elevation, then watch a touching video where a man does good deeds for people in his community. Finally, they plan a positive action they can take to help others in their own life.

Group Type EXPERIMENTAL

Moral Elevation

Intervention Type BEHAVIORAL

Users learn about moral elevation, then watch a touching video where a man does good deeds for people in his community (originally a Thai life insurance advertisement). Finally, they plan a positive action they can take to help others in their own life.

SSI 3: Mindful Attention Skills

A series of videos teach mindfulness skills: how to release thoughts and re-evaluate.

Group Type EXPERIMENTAL

Mindful Attention Skills

Intervention Type BEHAVIORAL

A series of videos teach mindfulness skills: how to release thoughts and re-evaluate negative interpretations.

SSI 4: 5 Habits to Beat Depression

A clinical psychologist and science communicator describes his top 5 one-minute habits to beat depression.

Group Type EXPERIMENTAL

5 Habits to Beat Depression

Intervention Type BEHAVIORAL

A clinical psychologist and science communicator describes his top 5 one-minute habits to beat depression.

SSI 5: Interactive Cognitive Reappraisal

An interactive SSI where participants learn how to reframe negative thoughts.

Group Type EXPERIMENTAL

Interactive Cognitive Reappraisal

Intervention Type BEHAVIORAL

An interactive SSI where participants learn how to reframe negative thoughts

SSI 6: Expressive Writing (AI-supported)

Participants describe a persistent negative thought they struggle with and a large language model system helps them to consider a story in which someone learns to overcome that thought.

Group Type EXPERIMENTAL

Expressive Writing (AI-supported)

Intervention Type BEHAVIORAL

Participants describe a negative thought they struggle with and an LLM helps them to consider a story in which a peer overcomes that thought.

SSI 7: Inner Child Healing Walk

An interactive journey to reconnect and heal one's inner child through breathing exercises, positive affirmations, and supportive animal companions.

Group Type EXPERIMENTAL

Inner Child Healing Walk

Intervention Type BEHAVIORAL

An interactive journey to reconnect and heal one's inner child through breathing exercises, positive affirmations, and supportive animal companions.

SSI 8: Savoring Strategies

An SSI introducing savoring strategies to improve mood.

Group Type EXPERIMENTAL

Savoring Strategies

Intervention Type BEHAVIORAL

An SSI introducing savoring strategies to improve mood.

SSI 9: Personalized Intervention Recommender

Identifies the kinds of depression one struggles most with and offers a personalized recommendation for future depression support options.

Group Type EXPERIMENTAL

Personalized Intervention Recommender

Intervention Type BEHAVIORAL

Identifies the kinds of depression one struggles most with and offers a personalized recommendation for future depression support options

SSI 10: Dialectical Behavioral Therapy Skills

Presents videos from dialectical behavioral therapy on various ways to control negative emotions.

Group Type EXPERIMENTAL

Dialectical Behavioral Therapy Skills

Intervention Type BEHAVIORAL

Presents videos from dialectical behavioral therapy on various ways to control negative emotions.

SSI 11: Reframing Negative Thoughts

An audio-only program in which users are guided to reflect on how they might challenge negative automatic thoughts and beliefs they struggle with.

Group Type EXPERIMENTAL

Reframing Negative Thoughts

Intervention Type BEHAVIORAL

An audio-only program in which users are guided to reflect on how they might challenge negative automatic thoughts and beliefs they struggle with.

Interventions

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Behavioral Activation (Action Brings Change Project 10-Minute Version)

A behavioral activation SSI where users learn about negative thought spirals, give advice to an imagined peer, then create an "action plan" of helpful activities to do in the near future. This is a shorter version of the original 15-minute Action Brings Change SSI.

Intervention Type BEHAVIORAL

Mindful Acceptance

A clinical psychologist explains a few ways to use mindful acceptance to deal with difficult thoughts and feelings.

Intervention Type BEHAVIORAL

Moral Elevation

Users learn about moral elevation, then watch a touching video where a man does good deeds for people in his community (originally a Thai life insurance advertisement). Finally, they plan a positive action they can take to help others in their own life.

Intervention Type BEHAVIORAL

Mindful Attention Skills

A series of videos teach mindfulness skills: how to release thoughts and re-evaluate negative interpretations.

Intervention Type BEHAVIORAL

5 Habits to Beat Depression

A clinical psychologist and science communicator describes his top 5 one-minute habits to beat depression.

Intervention Type BEHAVIORAL

Interactive Cognitive Reappraisal

An interactive SSI where participants learn how to reframe negative thoughts

Intervention Type BEHAVIORAL

Expressive Writing (AI-supported)

Participants describe a negative thought they struggle with and an LLM helps them to consider a story in which a peer overcomes that thought.

Intervention Type BEHAVIORAL

Inner Child Healing Walk

An interactive journey to reconnect and heal one's inner child through breathing exercises, positive affirmations, and supportive animal companions.

Intervention Type BEHAVIORAL

Savoring Strategies

An SSI introducing savoring strategies to improve mood.

Intervention Type BEHAVIORAL

Personalized Intervention Recommender

Identifies the kinds of depression one struggles most with and offers a personalized recommendation for future depression support options

Intervention Type BEHAVIORAL

Dialectical Behavioral Therapy Skills

Presents videos from dialectical behavioral therapy on various ways to control negative emotions.

Intervention Type BEHAVIORAL

All about Trout

An 8-10 minute educational program with information and interactive exercises about trout fish. Intended to capture one's attention and require some effort, while minimizing influence on depressive symptoms.

Intervention Type BEHAVIORAL

Reframing Negative Thoughts

An audio-only program in which users are guided to reflect on how they might challenge negative automatic thoughts and beliefs they struggle with.

Intervention Type BEHAVIORAL

Other Intervention Names

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ABC Project Passive control activity

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Jessica Schleider

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Northwestern University Medical Social Sciences

Chicago, Illinois, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 24379447 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26926484 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8636885 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23756722 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31759277 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11556941 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11483841 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11132119 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 4436473 (View on PubMed)

Kaveladze B, Voelkel J, Stagnaro M, Huang M, Smock A, Sullivan E, Xu Y, McCall M, Zapata JP, Ishtiaque S, Bhattacharjee A, Georgieva I, Hernandez-Ramos R, Huber K, Jennings J, Kirk A, Kornfield R, Knowles R, Lind M, Liu M, Liut M, Mariakakis A, Mattu A, McGuire A, Meyerhoff J, Mrazek A, Mrazek M, Mohr D, Morris R, Mosunic C, Nip H, Olson-Urtecho A, Podell J, Ransom D, Rizvi S, Southward M, Stoeckl SE, Taylor M, Texter A, Trotter A, Tower C, Williams J, Woodson E, Wislocki K, Protzko J, Lorenzo-Luaces L, Schueller S, Nock M, Schleider J. A Crowdsourced Megastudy of 12 Digital Single-Session Interventions for Depression in American Adults. Res Sq [Preprint]. 2025 Aug 25:rs.3.rs-7236847. doi: 10.21203/rs.3.rs-7236847/v1.

Reference Type DERIVED
PMID: 40909806 (View on PubMed)

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Related Links

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https://osf.io/agvh6

Study Open Science Framework page with data and more information

Other Identifiers

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5T32MH115882-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STU 00220193

Identifier Type: -

Identifier Source: org_study_id

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