What SSI Duration is Most Effective? An Online Experiment With American Adults

How Long Should a Behavioral Activation Single-session Intervention be? A Four-armed Trial Comparing Effectiveness by Intervention Duration

In a previous study (https://osf.io/qdznc), the research team found that an 8-minute version of a single-session intervention for loneliness was more effective than a 23-minute version of it. The present work aims to further explore the relationship between intervention duration and effectiveness.

In this online trial, participants will be randomized to a 15-minute single-session depression intervention called the Action Brings Change (ABC) Program, a 10-minute version of it, a 6-minute version of it, or a 2-minute version of it. The main analysis will evaluate how change in depressive symptoms over eight weeks differs across conditions.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: Action Brings Change Project (15-minute adult version); Behavioral: Action Brings Change Project (10-minute adult version); Behavioral: Action Brings Change Project (6-minute adult version); Behavioral: Action Brings Change Project (2-minute adult version)

• Study Type: Interventional
• Enrollment (Actual): 1145
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Medical Social Sciences

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria: Participants must be:

• Located in the United States
• At least 18 years old
• Patient Health Questionnaire-8 (PHQ-8) score of at least 10 (moderate or more severe) at screener.
• Able to read and speak fluent English
• Able to access to the internet via a computer, tablet or smartphone for the next eight weeks

Exclusion Criteria:

• Participants who have completed the first session of the study before or completed another study testing a depression intervention from our laboratory via the same participant recruitment platform in the past two months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 15-minute single-session depression intervention; This is the adult version of the Action Brings Change (ABC) Project.	Behavioral: Action Brings Change Project (15-minute adult version); The ABC Project is a self-guided online single-session intervention based on principles of behavioral activation. In a slightly different form intended for adolescents, it has demonstrated efficacy in several studies. Its adult version has also shown some efficacy.; Other Names: ABC Project (15-min)
Experimental: 10-minute single-session depression intervention; This includes a shortened version of the ABC Project.	Behavioral: Action Brings Change Project (10-minute adult version); This is a 10-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.; Other Names: ABC Project (10-min)
Experimental: 6-minute single-session depression intervention; This includes a shortened version of the ABC Project.	Behavioral: Action Brings Change Project (6-minute adult version); This is a 6-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.; Other Names: ABC Project (6-min)
Experimental: 2-minute single-session depression intervention; This includes a shortened version of the ABC Project.	Behavioral: Action Brings Change Project (2-minute adult version); This is a 2-minute shortened version of the 15-minute adult version of the ABC Project. The research team created it and pilot-tested it.; Other Names: ABC Project (2-min)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009)	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 weeks post-intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Beck Hopelessness Scale at 8 weeks (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 8 weeks post-intervention
Change in Beck Hopelessness Scale - 4-item at 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.	Baseline to immediately post-intervention
Change in UCLA Loneliness Scale 3-item version at 8-week follow-up (ULS-3; Hughes et al., 2004)	The ULS-3 is the 3-item version of the 20-item UCLA Loneliness Scale. The measure includes questions such as "how often do you feel left out" with responses ranging from 1 (hardly ever) to 3 (often), producing a total score between 3 and 9. Researchers have labeled people who score 3-5 as "not lonely" and those who score 6-9 as "lonely."	Baseline to 8 weeks post-intervention
Change in Frequency of actions and thoughts scale at post-test at 8 weeks post-intervention (FATS; Terides et al., 2016)	A 12-item measure of adaptive thoughts and behaviors, improvement in which might be a target of cognitive behavioral therapy. Range 0-48 with higher scores indicating greater frequency of adaptive thoughts and behaviors.	Baseline to 8 weeks post-intervention
Presence of an "Aha! moment" at post-intervention	The survey will ask participants if they experienced an "Aha! moment" during the SSI.	Immediately post-intervention
Presence of an "Aha! moment" at 8 weeks post-intervention	The survey will ask participants if they experienced an "Aha! moment" during the SSI.	8 weeks post-intervention
Significance of the "Aha! moment" at immediately post-intervention	Among participants who report an Aha! Moment, the survey will ask how significant they felt that Aha! was (on a scale from 1 [not at all significant] - 5 [extremely significant]).	Immediately post-intervention
Significance of the "Aha! moment" at 8 weeks post-intervention	Among participants who report an Aha! Moment, the survey will ask how significant they felt that Aha! was (on a scale from 1 [not at all significant] - 5 [extremely significant]).	8 weeks post-intervention
Expected improvement at post-intervention (from the Credibility / Expectancy Questionnaire; Devilly, 2004)	This will be computed as the sum of two items: "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?"). Each item will be rated from 1-9 and will be summed together to create a total score of 2-18 with higher scores indicating greater expected improvement.	Immediately post-intervention
Self-reported improvement at 8-weeks post-intervention (adapted from the Credibility/ Expectancy Questionnaire; Devilly, 2004)	This will be computed as the sum of two items: "At this point, how successful do you think this treatment was in reducing your feelings of depression?" and "Over the past eight weeks, how much improvement in your feelings of depression do you think occurred?"). Each item will be rated from 1-9 and will be summed together to create a total score of 2-18 with higher scores indicating greater improvement.	8 weeks post-intervention
Intervention satisfaction star rating at post-intervention	The survey will evaluate participants' satisfaction with 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.	Immediately post-intervention
Intervention satisfaction star rating at 8 week follow-up	The survey will evaluate participants' satisfaction with 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.	8 weeks post-intervention

Collaborators and Investigators

• Sponsor: Northwestern University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Jessica L Schleider, PhD, 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.
• Hughes ME, Waite LJ, Hawkley LC, Cacioppo JT. A Short Scale for Measuring Loneliness in Large Surveys: Results From Two Population-Based Studies. Res Aging. 2004;26(6):655-672. doi: 10.1177/0164027504268574.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2024
• Primary Completion (Actual): May 22, 2024
• Study Completion (Actual): May 22, 2024

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 15, 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: Effectiveness; Length; Duration; Single-session intervention; Active elements
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: STU00220591_shortening; 2T32MH115882-06A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be made available once they are anonymized and all the planned analyses have been completed by the investigators.
• IPD Sharing Time Frame: Anonymized data and code will be made publicly available here (https://osf.io/g846j/) upon publication of trial results.
• IPD Sharing Access Criteria: Publicly available
• IPD Sharing Supporting Information Type: SAP; 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