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Completed

NCT Number: NCT06313736

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University Medical Social Sciences

Chicago, Illinois, 60611, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Action Brings Change Project (15-minute adult version)

Behavioral

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)

Action Brings Change Project (10-minute adult version)

Behavioral

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)

Action Brings Change Project (6-minute adult version)

Behavioral

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)

Action Brings Change Project (2-minute adult version)

Behavioral

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)

Primary outcomes

  1. Change in Patient Health Questionnaire-8 at 8 weeks (PHQ-8; Kroenke et al., 2009)

    Time frame: Baseline to 8 weeks post-intervention

    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.

Secondary outcomes

  1. Change in Beck Hopelessness Scale at 8 weeks (BHS-4; Perczel Forintos et al., 2013)

    Time frame: Baseline to 8 weeks 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.

  2. Change in Beck Hopelessness Scale - 4-item at post-intervention

    Time frame: Baseline to immediately 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.

  3. Change in UCLA Loneliness Scale 3-item version at 8-week follow-up (ULS-3; Hughes et al., 2004)

    Time frame: Baseline to 8 weeks post-intervention

    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."

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

    Time frame: Immediately post-intervention

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

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

    Time frame: 8 weeks post-intervention

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

  6. Significance of the "Aha! moment" at immediately post-intervention

    Time frame: 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]).

  7. Significance of the "Aha! moment" at 8 weeks post-intervention

    Time frame: 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. Change in Frequency of actions and thoughts scale at post-test at 8 weeks post-intervention (FATS; Terides et al., 2016)

    Time frame: Baseline to 8 weeks post-intervention

    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.

  9. Expected improvement at post-intervention (from the Credibility / Expectancy Questionnaire; Devilly, 2004)

    Time frame: Immediately post-intervention

    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.

  10. Self-reported improvement at 8-weeks post-intervention (adapted from the Credibility/ Expectancy Questionnaire; Devilly, 2004)

    Time frame: 8 weeks post-intervention

    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.

  11. Intervention satisfaction star rating at post-intervention

    Time frame: Immediately 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.

  12. Intervention satisfaction star rating at 8 week follow-up

    Time frame: 8 weeks 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • National Institute of Mental Health (NIMH)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 15, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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