Active Elements of Digital Single-session Interventions
NCT ID: NCT06322849
Last Updated: 2024-09-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
887 participants
INTERVENTIONAL
2024-05-02
2024-07-18
Brief Summary
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The primary aim of this study is to calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.
The secondary aims of this study are to:
1. calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on PHQ-8 scores at immediate post-treatment and 2-week follow-up.
2. calculate the interaction effects, if any, among the candidate components on PHQ-8 scores at immediate post-treatment, 2-week, and 8-week follow-up.
3. calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.
4. determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence.
Additionally, the exploratory aim of this study is to determine if common factors, like credibility of the intervention and expectations to improve, can lead to symptom change.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
SINGLE
Study Groups
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Arm 1
Experimental: Breathing exercise + active elements 1, 2, 3
In this arm, all three factors are set to active (i.e. yes):
* Psychoeducation
* Testimonials and Saying is believing exercises
* Action planning
Psychoeducation
Psychoeducation is a potential active element of Project ABC. In psychoeducation, participants learn about the cognitive model of behavior and how they can take action to change their moods.
Testimonials and Saying is believing exercises
Testimonials and Saying is believing exercises is a potential active element of Project ABC. In this element, participants learn about how others have taken action to improve their mood and complete one exercise where they give advice to a virtual peer who is stuck in a negative spiral.
Action planning
Action planning is a potential active element of Project ABC. In this element, participants plan in detail an action they can take to get out of the negative mood spiral.
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Arm 2
Experimental: Breathing exercise + active elements 1, 2
In this arm, two factors are set to active (i.e. yes):
* Psychoeducation
* Testimonials and Saying is believing exercises
Psychoeducation
Psychoeducation is a potential active element of Project ABC. In psychoeducation, participants learn about the cognitive model of behavior and how they can take action to change their moods.
Testimonials and Saying is believing exercises
Testimonials and Saying is believing exercises is a potential active element of Project ABC. In this element, participants learn about how others have taken action to improve their mood and complete one exercise where they give advice to a virtual peer who is stuck in a negative spiral.
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Arm 3
Experimental: Breathing exercise + active elements 1, 3
In this arm, two factors are set to active (i.e. yes):
* Psychoeducation
* Action planning
Psychoeducation
Psychoeducation is a potential active element of Project ABC. In psychoeducation, participants learn about the cognitive model of behavior and how they can take action to change their moods.
Action planning
Action planning is a potential active element of Project ABC. In this element, participants plan in detail an action they can take to get out of the negative mood spiral.
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Arm 4
Experimental: Breathing exercise + active elements 2, 3
In this arm, two factors are set to active (i.e. yes):
* Testimonials and Saying is believing exercises
* Action planning
Testimonials and Saying is believing exercises
Testimonials and Saying is believing exercises is a potential active element of Project ABC. In this element, participants learn about how others have taken action to improve their mood and complete one exercise where they give advice to a virtual peer who is stuck in a negative spiral.
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Arm 5
Experimental: Breathing exercise + active element 1
In this arm, one factor is set to active (i.e. yes):
• Psychoeducation
Psychoeducation
Psychoeducation is a potential active element of Project ABC. In psychoeducation, participants learn about the cognitive model of behavior and how they can take action to change their moods.
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Arm 6
Experimental: Breathing exercise + active element 2
In this arm, one factor is set to active (i.e. yes):
• Testimonials and Saying is believing exercises
Testimonials and Saying is believing exercises
Testimonials and Saying is believing exercises is a potential active element of Project ABC. In this element, participants learn about how others have taken action to improve their mood and complete one exercise where they give advice to a virtual peer who is stuck in a negative spiral.
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Arm 7
Experimental: Breathing exercise + active element 3
In this arm, one factor is set to active (i.e. yes):
• Action planning
Action planning
Action planning is a potential active element of Project ABC. In this element, participants plan in detail an action they can take to get out of the negative mood spiral.
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Arm 8
Experimental: Breathing exercise only
In this arm, none of the three factors are set to active (i.e. yes)
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Interventions
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Psychoeducation
Psychoeducation is a potential active element of Project ABC. In psychoeducation, participants learn about the cognitive model of behavior and how they can take action to change their moods.
Testimonials and Saying is believing exercises
Testimonials and Saying is believing exercises is a potential active element of Project ABC. In this element, participants learn about how others have taken action to improve their mood and complete one exercise where they give advice to a virtual peer who is stuck in a negative spiral.
Action planning
Action planning is a potential active element of Project ABC. In this element, participants plan in detail an action they can take to get out of the negative mood spiral.
Breathing exercise
Participants will be presented with a one-minute breathing exercise.
Eligibility Criteria
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Inclusion Criteria
* Baseline Patient Health Questionnaire-8 (PHQ-8) score \>= 10
* Able to read and write English
* Able to access to the internet via a computer, tablet or smartphone for the next eight weeks
Exclusion Criteria
* Participants who have submitted gibberish in open response questions
18 Years
35 Years
ALL
No
Sponsors
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Northwestern University
OTHER
Responsible Party
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Jessica Schleider
Associate Professor, Northwestern University
Principal Investigators
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Jessica L Schleider
Role: PRINCIPAL_INVESTIGATOR
Northwestern University
Locations
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Northwestern University
Chicago, Illinois, United States
Countries
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References
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Schleider JL, Mullarkey MC, Fox KR, Dobias ML, Shroff A, Hart EA, Roulston CA. A randomized trial of online single-session interventions for adolescent depression during COVID-19. Nat Hum Behav. 2022 Feb;6(2):258-268. doi: 10.1038/s41562-021-01235-0. Epub 2021 Dec 9.
Kroenke K, Strine TW, Spitzer RL, Williams JB, Berry JT, Mokdad AH. The PHQ-8 as a measure of current depression in the general population. J Affect Disord. 2009 Apr;114(1-3):163-73. doi: 10.1016/j.jad.2008.06.026. Epub 2008 Aug 27.
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.
Sheldon, K.M., Hilpert, J.C. The balanced measure of psychological needs (BMPN) scale: An alternative domain general measure of need satisfaction. Motiv Emot 36, 439-451 (2012). https://doi.org/10.1007/s11031-012-9279-4
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.
Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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STU00220591
Identifier Type: -
Identifier Source: org_study_id
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