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Depression - Major Depressive DisorderNCT06856668

A Megastudy of Single-Session Interventions for Depression

A study testing Behavioral Activation (Action Brings Change Project 10-Minute Version), Mindful Acceptance and Moral Elevation in people with Depression - Major Depressive Disorder, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression - Major Depressive Disorder
What is being tested?
Behavioral Activation (Action Brings Change Project 10-Minute Version), Mindful Acceptance and Moral Elevation
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,505 participants
Where
1 siteUnited States
Study dates
11 Mar 2025to 24 Jun 2025
Phase
Interventional
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

None listed.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Northwestern University Medical Social Sciences

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: A Megastudy of Single-Session Interventions to Challenge Depression in American Adults

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.

Being tested
Behavioral Activation (Action Brings Change Project 10-Minute Version), Mindful Acceptance, Moral Elevation, Mindful Attention Skills, 5 Habits to Beat Depression
Keywords
single-session intervention, depression, megastudy, digital mental health intervention, experiment, randomized clinical trial
Medical subject headings
Depression

What participants receive

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

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

    Also called ABC Project

    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.

  • Mindful AcceptanceBehavioural

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

  • Moral ElevationBehavioural

    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.

  • Mindful Attention SkillsBehavioural

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

  • 5 Habits to Beat DepressionBehavioural

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

  • Interactive Cognitive ReappraisalBehavioural

    An interactive SSI where participants learn how to reframe negative thoughts

  • Expressive Writing (AI-supported)Behavioural

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

  • Inner Child Healing WalkBehavioural

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

  • Savoring StrategiesBehavioural

    An SSI introducing savoring strategies to improve mood.

  • Personalized Intervention RecommenderBehavioural

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

  • Dialectical Behavioral Therapy SkillsBehavioural

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

  • All about TroutBehavioural

    Also called Passive control activity

    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.

  • Reframing Negative ThoughtsBehavioural

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

Study groups in NCT06856668
Study groupRoleWhat they receive
Passive control (All About Trout)OtherThe 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).
Receives: Behavioral: All about Trout
Behavioral Activation (Action Brings Change Project)Active comparatorA 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.
Receives: Behavioral: Behavioral Activation (Action Brings Change Project 10-Minute Version)
SSI 1: Mindful AcceptanceExperimentalA clinical psychologist explains a few ways to use mindful acceptance to deal with difficult thoughts and feelings.
Receives: Behavioral: Mindful Acceptance
SSI 2: Moral ElevationExperimentalUsers 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.
Receives: Behavioral: Moral Elevation
SSI 3: Mindful Attention SkillsExperimentalA series of videos teach mindfulness skills: how to release thoughts and re-evaluate.
Receives: Behavioral: Mindful Attention Skills
SSI 4: 5 Habits to Beat DepressionExperimentalA clinical psychologist and science communicator describes his top 5 one-minute habits to beat depression.
Receives: Behavioral: 5 Habits to Beat Depression
SSI 5: Interactive Cognitive ReappraisalExperimentalAn interactive SSI where participants learn how to reframe negative thoughts.
Receives: Behavioral: Interactive Cognitive Reappraisal
SSI 6: Expressive Writing (AI-supported)ExperimentalParticipants 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.
Receives: Behavioral: Expressive Writing (AI-supported)
SSI 7: Inner Child Healing WalkExperimentalAn interactive journey to reconnect and heal one's inner child through breathing exercises, positive affirmations, and supportive animal companions.
Receives: Behavioral: Inner Child Healing Walk
SSI 8: Savoring StrategiesExperimentalAn SSI introducing savoring strategies to improve mood.
Receives: Behavioral: Savoring Strategies
SSI 9: Personalized Intervention RecommenderExperimentalIdentifies the kinds of depression one struggles most with and offers a personalized recommendation for future depression support options.
Receives: Behavioral: Personalized Intervention Recommender
SSI 10: Dialectical Behavioral Therapy SkillsExperimentalPresents videos from dialectical behavioral therapy on various ways to control negative emotions.
Receives: Behavioral: Dialectical Behavioral Therapy Skills
SSI 11: Reframing Negative ThoughtsExperimentalAn audio-only program in which users are guided to reflect on how they might challenge negative automatic thoughts and beliefs they struggle with.
Receives: Behavioral: Reframing Negative Thoughts

What is being measured

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

  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.

    Measured: Baseline to week 4

Secondary outcomes (15)
  1. Change in Beck Hopelessness Scale at immediate post-intervention (BHS-4; Perczel Forintos et al., 2013)

    Beck Hopelessness Scale-4 is the 4-item version of the 20-item Beck Hopelessness scale (Beck et al. 1974). Participants will be asked to rate 4 items assessing different aspects of hopelessness (e.g., My future seems dark to me) on a scale of 0 (Absolutely disagree) to 3 (Absolutely agree). Total score can range between 0 to 12 with higher scores indicating higher hopelessness.

    Measured: Baseline to immediate post-intervention

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

    Beck Hopelessness Scale-4 is the 4-item version of the 20-item Beck Hopelessness scale (Beck et al. 1974). Participants will be asked to rate 4 items assessing different aspects of hopelessness (e.g., My future seems dark to me) on a scale of 0 (Absolutely disagree) to 3 (Absolutely agree). Total score can range between 0 to 12 with higher scores indicating higher hopelessness.

    Measured: Baseline to week 4

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

    The "pathways" subscale reflects perceived success in meeting one's goals (eg, "At this time, I am meeting the goals I have set for myself"). Immediately pre- and post-intervention, participants rate each of 3 statements to reflect how they felt about themselves right now on an 8-point Likert scale.

    Measured: Baseline to immediate post-intervention

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

    The "pathways" subscale reflects perceived success in meeting one's goals (eg, "At this time, I am meeting the goals I have set for myself"). Immediately pre- and post-intervention, participants rate each of 3 statements to reflect how they felt about themselves right now on an 8-point Likert scale.

    Measured: Baseline to week 4

  5. Change in Readiness for Change at immediate post-intervention

    To evaluate readiness for change at pre-test, post-test, and follow-up, participants will be asked two questions regarding making changes to reduce their feelings of depression: 1. "How important is making changes toward overcoming depression to you right now?" (1-4, Not at all- Extremely important) and 2. "How confident are you about making changes toward overcoming depression?" (1-4, Not at all- Extremely confident).

    Measured: Baseline to immediate post-intervention

  6. Change in Readiness for Change at week 4

    To evaluate readiness for change at pre-test, post-test, and follow-up, participants will be asked two questions regarding making changes to reduce their feelings of depression: 1. "How important is making changes toward overcoming depression to you right now?" (1-4, Not at all- Extremely important) and 2. "How confident are you about making changes toward overcoming depression?" (1-4, Not at all- Extremely confident).

    Measured: Baseline to week 4

  7. Change in Depression Expectancies for Change at immediate post-intervention (Eddington et al., 2014)

    To evaluate how much people expect to be able to change their symptoms of depression, participants will respond to the three items with the highest item-total correlation from the Depression Expectancies for Change scale (Eddington et al., 2014). These are rated on a 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree). Items 1 and 2 are reverse-coded.

    Measured: Baseline to immediate post-intervention

  8. Change in Depression Expectancies for Change at week 4 (Eddington et al., 2014)

    To evaluate how much people expect to be able to change their symptoms of depression, participants will be asked to respond to three items with the highest item-total correlation from the Depression Expectancies for Change scale (Eddington et al., 2014). These are rated on a 5-point likert scale from 1 (strongly disagree) to 5 (strongly agree). Items 1 and 2 are reverse-coded.

    Measured: Baseline to week 4

  9. Change in Frequency of Actions and Thoughts Scale at immediate post-intervention (FATS; Terides et al., 2016).

    A 12-item measure of adaptive thoughts and behaviors, improvement in which might be a target of psychotherapy. Range 0-48 with higher scores indicating greater frequency of adaptive thoughts and behaviors.

    Measured: Baseline to immediate post-intervention

  10. Change in Frequency of Actions and Thoughts Scale at week 4 (FATS; Terides et al., 2016).

    A 12-item measure of adaptive thoughts and behaviors, improvement in which might be a target of psychotherapy. Range 0-48 with higher scores indicating greater frequency of adaptive thoughts and behaviors.

    Measured: Baseline to week 4

  11. Credibility and Expectancy Questionnaire at immediate post-intervention (CEQ; Devilly & Borkovec; 2000)

    A 6-item measure of user-perceived intervention appeal and efficacy. Range 6-54 with higher scores indicating higher user-perceived intervention appeal and efficacy.

    Measured: immediate post-intervention

  12. Insight Experience at immediate post-intervention

    Participants will be asked two questions about users' insight experiences, with the following text:

    The next question will ask if you experienced an "Aha! Moment".

    You can think of this experience as a miniature 'Eureka moment'. You might even feel an internal sense of "Aha!," or you might think to yourself, "of course!," "that was so obvious". Not experiencing an Aha! moment might feel like nothing much at all.

    1. Did something in the program make you experience an Aha! Moment? (No 0 / Yes 1)
    2. How significant did you feel this Aha! Moment was? In other words, how much do you feel it will have a lasting impact on you? 1 (not at all significant) - 5 (very significant)

    Measured: immediate post-intervention

  13. Insight Experience at week four

    Participants will be asked three questions about whether they had an insight experience during the SSI, with the following text:

    The next question will ask if you experienced an "Aha! Moment".

    You can think of this experience as a miniature 'Eureka moment'. You might even feel an internal sense of "Aha!," or you might think to yourself, "of course!," "that was so obvious". Not experiencing an Aha! moment might feel like nothing much at all.

    1. Did something in the program make you experience an Aha! Moment *that you still remember today*? (No 0 / Yes 1)
    2. How significant did you feel this Aha! Moment was? In other words, how much do you feel it will have a lasting impact on you? 1 (not at all significant) - 5 (very significant)
    3. How much has the Aha! Moment you experienced changed the way that you think or act? 1 (not at all) - 5 (a great deal)

    Measured: week 4

  14. Star rating at immediate post-intervention

    Participants rate the overall quality of the program they completed from 1-5 stars, with 5 being the best. (5 stars to fill in, discrete 1-5)

    Measured: immediate post-intervention

  15. Star rating at week 4

    Participants rate the overall quality of the program they completed from 1-5 stars, with 5 being the best. (5 stars to fill in, discrete 1-5)

    Measured: week 4

Timeline

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

  1. First posted4 Mar 2025
  2. Study start11 Mar 2025
  3. Primary completion24 Jun 2025
  4. Study completion24 Jun 2025

Resources

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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
All intervention conditions will be allocated approximately the same number of participants, while the control condition will be allocated three times that number.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
7,505 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06856668
Sponsor's protocol ID
STU 00220193
Other IDs
5T32MH115882-07
Status last verified
Jun 2025
First submitted
27 Jan 2025
Last updated
27 Jun 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Researchers will share all non-identifiable individual participant data (IPD) from the study.

Publications

  • 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.

    PubMed 24379447
  • 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.

    PubMed 26926484
  • 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.

    PubMed 8636885
  • 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.

    PubMed 23756722
  • 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.

    PubMed 31759277
  • 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.

    PubMed 11556941
  • 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.

    PubMed 11483841
  • 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.

    PubMed 11132119
  • 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.

    PubMed 4436473
  • Kaveladze BT, Voelkel JG, Stagnaro MN, Huang M, Smock AE, Sullivan EK, Xu YM, McCall MP, Zapata JP, Ahmed SI, Bhattacharjee A, Georgieva I, Hernandez-Ramos R, Huber KS, Jennings JK, Kirk AC, Knowles RSM, Kornfield R, Lind MN, Liu M, Liut MA, Mariakakis AT, Mattu AM, McGuire AP, Meyerhoff J, Mrazek AJ, Mrazek MD, Mohr DC, Morris RR, Mosunic CJ, Nip H, Olson-Urtecho A, Podell JR, Ransom DS, Rizvi SL, Southward MW, Stoeckl SE, Taylor ME, Texter AR, Tower CV, Trotter AN, Williams JJ, Wislocki KE, Woodson EJ, Protzko J, Lorenzo-Luaces L, Schueller SM, Nock MK, Schleider JL. A crowdsourced megastudy of 12 digital single-session interventions for depression in US adults. Nat Hum Behav. 2026 May;10(5):906-922. doi: 10.1038/s41562-026-02415-6. Epub 2026 Mar 2.

    PubMed 41772060
  • 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.

    PubMed 40909806

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral Activation (Action Brings Change Project 10-Minute Version), Mindful Acceptance and Moral Elevation in people with Depression - Major Depressive Disorder, run by Northwestern University at 1 site in United States.

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 6 inclusion and 0 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: finished, as of the sponsor's last update on 27 Jun 2025. 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 United States. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient Health Questionnaire-9 at week 4 (PHQ-9; Kroenke et al., 2001) (time frame: Baseline to week 4). 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 NCT06856668, which also lists 11 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 27 Jun 2025.

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