A Megastudy of Single-Session Interventions for Depression

NCT06856668 | Completed

• 2 other identifiers: STU 002201935T32MH115882-07
• Study Type: interventional
• Target: 7,505
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression - Major Depressive Disorder

Keywords

single-session intervention; depression; megastudy; digital mental health intervention; experiment; randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in Patient Health Questionnaire-9 at week 4 (PHQ-9; Kroenke et al., 2001)

  The Patient Health Questionnaire-9 is a validated and self-administered measure to assess depression symptom severity in the general population. Participants are asked to rate how often they are bothered by 9 items (e.g., Poor appetite or overeating) on a scale of 0 (Not at all) to 3 (Nearly every day). Total score can range from 0 to 27, with higher scores indicating higher symptom severity.

  Baseline to week 4

Secondary Outcomes (15)

• Change in Beck Hopelessness Scale at immediate post-intervention (BHS-4; Perczel Forintos et al., 2013)

  Baseline to immediate post-intervention

• Change in Beck Hopelessness Scale at week 4 (BHS-4; Perczel Forintos et al., 2013)

  Baseline to week 4

• Change in Pathways Subscale of the State Hope Scale at immediate post-intervention (Snyder et al., 1996)

  Baseline to immediate post-intervention

• Change in Pathways Subscale of the State Hope Scale at week 4 (Snyder et al., 1996)

  Baseline to week 4

• Change in Readiness for Change at immediate post-intervention

  Baseline to immediate post-intervention

Study Arms (13)

Passive control (All About Trout)

OTHER

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).

Behavioral: All about Trout

Behavioral Activation (Action Brings Change Project)

ACTIVE COMPARATOR

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.

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

SSI 1: Mindful Acceptance

EXPERIMENTAL

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

Behavioral: Mindful Acceptance

SSI 2: Moral Elevation

EXPERIMENTAL

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.

Behavioral: Moral Elevation

SSI 3: Mindful Attention Skills

EXPERIMENTAL

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

Behavioral: Mindful Attention Skills

SSI 4: 5 Habits to Beat Depression

EXPERIMENTAL

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

Behavioral: 5 Habits to Beat Depression

SSI 5: Interactive Cognitive Reappraisal

EXPERIMENTAL

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

Behavioral: Interactive Cognitive Reappraisal

SSI 6: Expressive Writing (AI-supported)

EXPERIMENTAL

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.

Behavioral: Expressive Writing (AI-supported)

SSI 7: Inner Child Healing Walk

EXPERIMENTAL

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

Behavioral: Inner Child Healing Walk

SSI 8: Savoring Strategies

EXPERIMENTAL

An SSI introducing savoring strategies to improve mood.

Behavioral: Savoring Strategies

SSI 9: Personalized Intervention Recommender

EXPERIMENTAL

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

Behavioral: Personalized Intervention Recommender

SSI 10: Dialectical Behavioral Therapy Skills

EXPERIMENTAL

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

Behavioral: Dialectical Behavioral Therapy Skills

SSI 11: Reframing Negative Thoughts

EXPERIMENTAL

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

Behavioral: Reframing Negative Thoughts

Interventions

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

Also known as: ABC Project

Behavioral Activation (Action Brings Change Project)

Mindful Acceptance BEHAVIORAL

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

SSI 1: Mindful Acceptance

Moral Elevation 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 2: Moral Elevation

Mindful Attention Skills BEHAVIORAL

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

SSI 3: Mindful Attention Skills

5 Habits to Beat Depression BEHAVIORAL

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

SSI 4: 5 Habits to Beat Depression

Interactive Cognitive Reappraisal BEHAVIORAL

An interactive SSI where participants learn how to reframe negative thoughts

SSI 5: Interactive Cognitive Reappraisal

Expressive Writing (AI-supported) 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 6: Expressive Writing (AI-supported)

Inner Child Healing Walk BEHAVIORAL

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

SSI 7: Inner Child Healing Walk

Savoring Strategies BEHAVIORAL

An SSI introducing savoring strategies to improve mood.

SSI 8: Savoring Strategies

Personalized Intervention Recommender BEHAVIORAL

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

SSI 9: Personalized Intervention Recommender

Dialectical Behavioral Therapy Skills BEHAVIORAL

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

SSI 10: Dialectical Behavioral Therapy Skills

All about Trout 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.

Also known as: Passive control activity

Passive control (All About Trout)

Reframing Negative Thoughts 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.

SSI 11: Reframing Negative Thoughts

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Northwestern University Medical Social Sciences

Chicago, Illinois, 60611, United States

Location

Related Publications (10)

• 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.

  PMID: 24379447 BACKGROUND

• 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.

  PMID: 26926484 BACKGROUND

• 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.

  PMID: 8636885 BACKGROUND

• 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.

  PMID: 23756722 BACKGROUND

• 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.

  PMID: 31759277 BACKGROUND

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 11483841 BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

• 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.

  PMID: 4436473 BACKGROUND

• 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.

  PMID: 40909806 DERIVED

Related Links

• Study Open Science Framework page with data and more information

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: All intervention conditions will be allocated approximately the same number of participants, while the control condition will be allocated three times that number.

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: March 4, 2025
• Study Start: March 11, 2025
• Primary Completion: June 24, 2025
• Study Completion: June 24, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: The IPD and supporting information will be available by July 30, 2025, with no end date.
• Access Criteria: The IPD will be publicly available online via the study open science framework (OSF) page (https://osf.io/agvh6)

Locations

US (1)