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| ID | Type | Description | Link |
|---|---|---|---|
| 5T32MH115882-07 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| 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. |
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| SSI 1: Mindful Acceptance | Experimental | A clinical psychologist explains a few ways to use mindful acceptance to deal with difficult thoughts and feelings. |
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| 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. |
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| SSI 3: Mindful Attention Skills | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion criteria:
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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Medical Social Sciences | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24379447 | Background | 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. | |
| 26926484 | 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. |
| Label | URL |
|---|---|
| Study Open Science Framework page with data and more information | View source |
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Researchers will share all non-identifiable individual participant data (IPD) from the study.
The IPD and supporting information will be available by July 30, 2025, with no end date.
The IPD will be publicly available online via the study open science framework (OSF) page (https://osf.io/agvh6)
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Mar 8, 2025 |
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All intervention conditions will be allocated approximately the same number of participants, while the control condition will be allocated three times that number.
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A series of videos teach mindfulness skills: how to release thoughts and re-evaluate. |
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| SSI 4: 5 Habits to Beat Depression | Experimental | A clinical psychologist and science communicator describes his top 5 one-minute habits to beat depression. |
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| SSI 5: Interactive Cognitive Reappraisal | Experimental | An interactive SSI where participants learn how to reframe negative thoughts. |
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| 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. |
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| 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. |
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| SSI 8: Savoring Strategies | Experimental | An SSI introducing savoring strategies to improve mood. |
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| 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. |
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| SSI 10: Dialectical Behavioral Therapy Skills | Experimental | Presents videos from dialectical behavioral therapy on various ways to control negative emotions. |
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| 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. |
|
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| Mindful Acceptance | Behavioral | A clinical psychologist explains a few ways to use mindful acceptance to deal with difficult thoughts and feelings. |
|
| 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. |
|
| Mindful Attention Skills | Behavioral | A series of videos teach mindfulness skills: how to release thoughts and re-evaluate negative interpretations. |
|
| 5 Habits to Beat Depression | Behavioral | A clinical psychologist and science communicator describes his top 5 one-minute habits to beat depression. |
|
| Interactive Cognitive Reappraisal | Behavioral | An interactive SSI where participants learn how to reframe negative thoughts |
|
| 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. |
|
| 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. |
|
| Savoring Strategies | Behavioral | An SSI introducing savoring strategies to improve mood. |
|
| Personalized Intervention Recommender | Behavioral | Identifies the kinds of depression one struggles most with and offers a personalized recommendation for future depression support options |
|
| Dialectical Behavioral Therapy Skills | Behavioral | Presents videos from dialectical behavioral therapy on various ways to control negative emotions. |
|
| 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. |
|
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| 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. |
|
| Baseline to immediate post-intervention |
| 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. | Baseline to week 4 |
| 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. | Baseline to immediate post-intervention |
| 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. | Baseline to week 4 |
| 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). | Baseline to immediate post-intervention |
| 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). | Baseline to week 4 |
| 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. | Baseline to immediate post-intervention |
| 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. | Baseline to week 4 |
| 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. | Baseline to immediate post-intervention |
| 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. | Baseline to week 4 |
| 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. | immediate post-intervention |
| 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.
| immediate post-intervention |
| 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.
| week 4 |
| 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) | immediate post-intervention |
| 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) | week 4 |
| 8636885 | 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. |
| 23756722 | 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. |
| 31759277 | 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. |
| 11556941 | 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. |
| 11483841 | 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. |
| 11132119 | 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. |
| 4436473 | 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. |
| 41772060 | Derived | 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. |
| 40909806 | Derived | 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. |
| Mar 8, 2025 |
| Prot_SAP_ICF_001.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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