AzTrials
AzTrials

DepressionNCT06313736

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

A study testing Action Brings Change Project (15-minute adult version), Action Brings Change Project (10-minute adult version) and Action Brings Change Project (6-minute adult version) in people with Depression, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Depression
What is being tested?
Action Brings Change Project (15-minute adult version), Action Brings Change Project (10-minute adult version) and Action Brings Change Project (6-minute adult version)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,145 participants
Where
1 siteUnited States
Study dates
20 Mar 2024to 22 May 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Northwestern University Medical Social Sciences

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: 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.

Conditions
Depression
Being tested
Action Brings Change Project (15-minute adult version), Action Brings Change Project (10-minute adult version), Action Brings Change Project (6-minute adult version), Action Brings Change Project (2-minute adult version)
Keywords
Single-session intervention, Length, Duration, Effectiveness, Active elements
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Action Brings Change Project (15-minute adult version)Behavioural

    Also called ABC Project (15-min)

    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)Behavioural

    Also called ABC Project (10-min)

    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)Behavioural

    Also called ABC Project (6-min)

    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)Behavioural

    Also called ABC Project (2-min)

    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.

Study groups in NCT06313736
Study groupRoleWhat they receive
15-minute single-session depression interventionExperimentalThis is the adult version of the Action Brings Change (ABC) Project.
Receives: Behavioral: Action Brings Change Project (15-minute adult version)
10-minute single-session depression interventionExperimentalThis includes a shortened version of the ABC Project.
Receives: Behavioral: Action Brings Change Project (10-minute adult version)
6-minute single-session depression interventionExperimentalThis includes a shortened version of the ABC Project.
Receives: Behavioral: Action Brings Change Project (6-minute adult version)
2-minute single-session depression interventionExperimentalThis includes a shortened version of the ABC Project.
Receives: Behavioral: Action Brings Change Project (2-minute adult version)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to 8 weeks post-intervention

Secondary outcomes (12)

  1. 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.

    Measured: Baseline to 8 weeks post-intervention

  2. 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.

    Measured: Baseline to immediately post-intervention

  3. 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."

    Measured: Baseline to 8 weeks post-intervention

  4. Presence of an "Aha! moment" at post-intervention

    The survey will ask participants if they experienced an "Aha! moment" during the SSI.

    Measured: Immediately post-intervention

  5. Presence of an "Aha! moment" at 8 weeks post-intervention

    The survey will ask participants if they experienced an "Aha! moment" during the SSI.

    Measured: 8 weeks post-intervention

  6. 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]).

    Measured: Immediately post-intervention

  7. 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]).

    Measured: 8 weeks post-intervention

  8. 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.

    Measured: Baseline to 8 weeks post-intervention

  9. 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.

    Measured: Immediately post-intervention

  10. 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.

    Measured: 8 weeks post-intervention

  11. 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.

    Measured: Immediately post-intervention

  12. 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.

    Measured: 8 weeks post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2024
  2. Study start20 Mar 2024
  3. Primary completion22 May 2024
  4. Study completion22 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be assigned to one of four different conditions.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,145 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06313736
Sponsor's protocol ID
STU00220591_shortening
Other IDs
2T32MH115882-06A1
Status last verified
Sep 2024
First submitted
11 Mar 2024
Last updated
19 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Data will be made available once they are anonymized and all the planned analyses have been completed by the investigators.

Publications

  • 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.

    PubMed 34887544

  • 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.

    PubMed 18752852

  • 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.

    PubMed 23756722

  • 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.

    PubMed 11132119

  • 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.

    PubMed 26926484

  • 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.

    PubMed 18504506

Questions about this trial

What is this clinical trial studying?

A study testing Action Brings Change Project (15-minute adult version), Action Brings Change Project (10-minute adult version) and Action Brings Change Project (6-minute adult version) in people with Depression, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009) (time frame: Baseline to 8 weeks post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06313736, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in