Clinical trial NCT06313736: What SSI Duration is Most Effective? An Online Experiment With American Adults
Official title: How Long Should a Behavioral Activation Single-session Intervention be? A Four-armed Trial Comparing Effectiveness by Intervention Duration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Single-session intervention
Length
Duration
Effectiveness
Active elements
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-03-15
Enrollment: 1145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned to one of four different conditions.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009)
timeFrame: Baseline to 8 weeks post-intervention
Secondary outcomes:
measure: Change in Beck Hopelessness Scale at 8 weeks (BHS-4; Perczel Forintos et al., 2013)
timeFrame: Baseline to 8 weeks post-intervention
measure: Change in Beck Hopelessness Scale - 4-item at post-intervention
timeFrame: Baseline to immediately post-intervention
measure: Change in UCLA Loneliness Scale 3-item version at 8-week follow-up (ULS-3; Hughes et al., 2004)
timeFrame: Baseline to 8 weeks post-intervention
measure: Presence of an "Aha! moment" at post-intervention
timeFrame: Immediately post-intervention
measure: Presence of an "Aha! moment" at 8 weeks post-intervention
timeFrame: 8 weeks post-intervention
measure: Significance of the "Aha! moment" at immediately post-intervention
timeFrame: Immediately post-intervention
measure: Significance of the "Aha! moment" at 8 weeks post-intervention
timeFrame: 8 weeks post-intervention
measure: Change in Frequency of actions and thoughts scale at post-test at 8 weeks post-intervention (FATS; Terides et al., 2016)
timeFrame: Baseline to 8 weeks post-intervention
measure: Expected improvement at post-intervention (from the Credibility / Expectancy Questionnaire; Devilly, 2004)
timeFrame: Immediately post-intervention
measure: Self-reported improvement at 8-weeks post-intervention (adapted from the Credibility/ Expectancy Questionnaire; Devilly, 2004)
timeFrame: 8 weeks post-intervention
measure: Intervention satisfaction star rating at post-intervention
timeFrame: Immediately post-intervention
measure: Intervention satisfaction star rating at 8 week follow-up
timeFrame: 8 weeks post-intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Medical Social Sciences
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jessica L Schleider, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.