A Megastudy of Single-Session Interventions for Depression

Northwestern University

Status: Completed

Conditions: Depression - Major Depressive Disorder

Treatments: Behavioral: All about Trout; Behavioral: Dialectical Behavioral Therapy Skills; Behavioral: Savoring Strategies; Behavioral: Expressive Writing (AI-supported); Behavioral: Mindful Attention Skills; Behavioral: 5 Habits to Beat Depression; Behavioral: Moral Elevation; Behavioral: Inner Child Healing Walk; Behavioral: Mindful Acceptance; Behavioral: Reframing Negative Thoughts; Behavioral: Personalized Intervention Recommender; Behavioral: Behavioral Activation (Action Brings Change Project 10-Minute Version); Behavioral: Interactive Cognitive Reappraisal

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06856668

STU 00220193

5T32MH115882-07 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 7,505 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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7,505 participants in 13 patient groups

Passive control (All About Trout)

Other group

Description:

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).

Treatment:

Behavioral: All about Trout

Behavioral Activation (Action Brings Change Project)

Active Comparator group

Description:

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.

Treatment:

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

SSI 1: Mindful Acceptance

Experimental group

Description:

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

Treatment:

Behavioral: Mindful Acceptance

SSI 2: Moral Elevation

Experimental group

Description:

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.

Treatment:

Behavioral: Moral Elevation

SSI 3: Mindful Attention Skills

Experimental group

Description:

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

Treatment:

Behavioral: Mindful Attention Skills

SSI 4: 5 Habits to Beat Depression

Experimental group

Description:

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

Treatment:

Behavioral: 5 Habits to Beat Depression

SSI 5: Interactive Cognitive Reappraisal

Experimental group

Description:

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

Treatment:

Behavioral: Interactive Cognitive Reappraisal

SSI 6: Expressive Writing (AI-supported)

Experimental group

Description:

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.

Treatment:

Behavioral: Expressive Writing (AI-supported)

SSI 7: Inner Child Healing Walk

Experimental group

Description:

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

Treatment:

Behavioral: Inner Child Healing Walk

SSI 8: Savoring Strategies

Experimental group

Description:

An SSI introducing savoring strategies to improve mood.

Treatment:

Behavioral: Savoring Strategies

SSI 9: Personalized Intervention Recommender

Experimental group

Description:

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

Treatment:

Behavioral: Personalized Intervention Recommender

SSI 10: Dialectical Behavioral Therapy Skills

Experimental group

Description:

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

Treatment:

Behavioral: Dialectical Behavioral Therapy Skills

SSI 11: Reframing Negative Thoughts

Experimental group

Description:

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

Treatment:

Behavioral: Reframing Negative Thoughts