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| ID | Type | Description | Link |
|---|---|---|---|
| 2T32MH115882-06A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 15-minute single-session depression intervention | Experimental | This is the adult version of the Action Brings Change (ABC) Project. |
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| 10-minute single-session depression intervention | Experimental | This includes a shortened version of the ABC Project. |
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| 6-minute single-session depression intervention | Experimental | This includes a shortened version of the ABC Project. |
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| 2-minute single-session depression intervention | Experimental | This includes a shortened version of the ABC Project. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria: Participants must be:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Schleider, PhD | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University Medical Social Sciences | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34887544 | Background | 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. | |
| 18752852 | Background | 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. |
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Data will be made available once they are anonymized and all the planned analyses have been completed by the investigators.
Anonymized data and code will be made publicly available here (https://osf.io/g846j/) upon publication of trial results.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 17, 2024 |
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Participants will be assigned to one of four different conditions.
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Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. They will know that the study compares multiple interventions but will not know to which arm they have been assigned. Additionally, the measures will be self-administered, so there is no scope for evaluator bias. There will be no interaction between participants and investigators.
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| 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. |
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| 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. |
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| 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. |
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| 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 |
| 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 |
| 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 |
| 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 |
| 23756722 | Background | 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. |
| 11132119 | Background | 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. |
| 26926484 | Background | 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. |
| 18504506 | Background | 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. |
| Mar 17, 2024 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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