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Completed

NCT Number: NCT06856668

A Megastudy of Single-Session Interventions for Depression

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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Key information

Conditions

Depression - Major Depressive Disorder Behavior Behavioral Symptoms Depression

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Medical Social Sciences

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: ABC Project

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.

Other names: Passive control activity

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.

Primary outcomes

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

    Time frame: Baseline to week 4

    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.

Secondary outcomes

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

    Time frame: Baseline to immediate post-intervention

    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.

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

    Time frame: Baseline to week 4

    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.

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

    Time frame: Baseline to immediate post-intervention

    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.

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

    Time frame: Baseline to week 4

    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.

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

    Time frame: Baseline to 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).

  6. Change in Readiness for Change at week 4

    Time frame: Baseline to 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).

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

    Time frame: Baseline to immediate post-intervention

    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.

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

    Time frame: Baseline to week 4

    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.

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

    Time frame: Baseline to immediate post-intervention

    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.

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

    Time frame: Baseline to week 4

    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.

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

    Time frame: immediate post-intervention

    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.

  12. Insight Experience at immediate post-intervention

    Time frame: 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.

    • Did something in the program make you experience an Aha! Moment? (No 0 / Yes 1)
    • 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)

  13. Insight Experience at week four

    Time frame: week 4

    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.

    • Did something in the program make you experience an Aha! Moment *that you still remember today*? (No 0 / Yes 1)
    • 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)
    • How much has the Aha! Moment you experienced changed the way that you think or act? 1 (not at all) - 5 (a great deal)

  14. Star rating at immediate post-intervention

    Time frame: 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)

  15. Star rating at week 4

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 4, 2025
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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