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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06313736
• Other study ID #: STU00220591_shortening
• Secondary ID: 2T32MH115882-06A
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 20, 2024
• Est. completion date: May 2024

Study information

• Verified date: April 2024
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1100
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression

Intervention

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.
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Northwestern University Medical Social Sciences	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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