Active Elements of Digital Single-session Interventions

Factorial Trial Designed to Identify Active Elements of a Self-administered Digital Single-session Intervention Targeting Depressive Symptoms.

Depression is a leading cause of disability in young adults. However, access to care is limited due to structural and psychological barriers. Single-session interventions (SSIs) are structured programs designed to maximize the therapeutic output in one interaction between the patient and the provider or a program. Project ABC, a single-session intervention (SSI), has been shown to be effective in reducing depressive symptoms. Project ABC is based on four components-psychoeducation, testimonials, saying is believing exercises, and action planning. However, it is unclear what are the effects of the individual components.

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Psychoeducation; Behavioral: Testimonials and Saying is believing exercises; Behavioral: Action planning; Behavioral: Breathing exercise

• Study Type: Interventional
• Enrollment (Actual): 887
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Located in the United States
• 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 participated in another related study on depression from our laboratory via the same participant recruitment platform in the past two months
• Participants who have submitted gibberish in open response questions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

8

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Behavioral: 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.; Behavioral: 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.; Behavioral: 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.; Behavioral: Breathing exercise; Participants will be presented with a one-minute breathing exercise.
Experimental: 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	Behavioral: 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.; Behavioral: 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.; Behavioral: Breathing exercise; Participants will be presented with a one-minute breathing exercise.
Experimental: Arm 3; Experimental: Breathing exercise + active elements 1, 3 In this arm, two factors are set to active (i.e. yes): Psychoeducation; Action planning	Behavioral: 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.; Behavioral: 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.; Behavioral: Breathing exercise; Participants will be presented with a one-minute breathing exercise.
Experimental: 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	Behavioral: 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.; Behavioral: Breathing exercise; Participants will be presented with a one-minute breathing exercise.
Experimental: Arm 5; Experimental: Breathing exercise + active element 1 In this arm, one factor is set to active (i.e. yes): • Psychoeducation	Behavioral: 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.; Behavioral: Breathing exercise; Participants will be presented with a one-minute breathing exercise.
Experimental: 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	Behavioral: 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.; Behavioral: Breathing exercise; Participants will be presented with a one-minute breathing exercise.
Experimental: Arm 7; Experimental: Breathing exercise + active element 3 In this arm, one factor is set to active (i.e. yes): • Action planning	Behavioral: 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.; Behavioral: Breathing exercise; Participants will be presented with a one-minute breathing exercise.
Experimental: Arm 8; Experimental: Breathing exercise only In this arm, none of the three factors are set to active (i.e. yes)	Behavioral: Breathing exercise; Participants will be presented with a one-minute breathing exercise.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-8	Patient Health Questionnaire-8 is a well-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 8 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 24, with higher scores indicating higher symptom severity.	Baseline to 8-week post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-8	Patient Health Questionnaire-8 is a well-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 8 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 24, with higher scores indicating higher symptom severity.	Baseline to 2-week post-intervention
Beck Hopelessness Scale-4	Beck Hopelessness Scale-4 is the 4-item version of the 20-item Beck Hopelessness scale. 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 immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention
Balanced measure of Psychological Needs scale	The BMPN is used as a measure of the psychological needs of autonomy, relatedness, and competence as laid out by the Self-Determination Theory. It is an 18-item questionnaire where each item is rated on a scale of 1 (Strongly disagree) to 5 (Strongly agree). Scores corresponding to each psychological need will be calculated based on the items corresponding to that need. A higher score on the three needs indicates higher wellbeing. In this study, we will use a 6-item version of the scale.	Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Credibility/Expectancy questionnaire	Two questions from Credibility/Expectancy questionnaire will be used: "At this point, how successful do you think this treatment will be in reducing your feelings of depression?" and "Over the next few weeks, how much improvement in your feelings of depression do you think will occur?" Participants will be asked to answer the questions on a scale of 1 (Not at all) to 9 (Very much).	Baseline and immediate post-intervention; The second question will also be asked at 2-week post-intervention
Intervention satisfaction star rating at post-intervention	Participants will be asked to rate the intervention they completed using a star rating from 1 to 5 stars, with 1 star indicating very low satisfaction and 5 stars indicating very high satisfaction.	Immediate post-intervention

Collaborators and Investigators

• Sponsor: Northwestern University
• Investigators: Principal Investigator: Jessica L Schleider, Northwestern University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2024
• Primary Completion (Actual): July 18, 2024
• Study Completion (Actual): July 18, 2024

Study Registration Dates

• First Submitted: March 10, 2024
• First Submitted That Met QC Criteria: March 14, 2024
• First Posted (Actual): March 21, 2024

Study Record Updates

• Last Update Posted (Actual): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 16, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: Depression; Factorial trial; Active elements; Single-session interventions
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STU00220591

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available once all the planned analyses have been completed by the investigators.
• IPD Sharing Time Frame: Data and code will be made available here (https://osf.io/xbpsj/) upon publication of trial results.
• IPD Sharing Access Criteria: Will be decided on a case-by-case basis
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No