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Depression is a leading cause of disability in young adults. However, access to care is limited due to structural and psychological barriers. Single-session interventions (SSIs) are structured programs designed to maximize the therapeutic output in one interaction between the patient and the provider or a program. Project ABC, a single-session intervention (SSI), has been shown to be effective in reducing depressive symptoms. Project ABC is based on four components-psychoeducation, testimonials, saying is believing exercises, and action planning. However, it is unclear what are the effects of the individual components.
The primary aim of this study is to calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on Patient Health Questionnaire-8 (PHQ-8) scores at 8-week follow-up.
The secondary aims of this study are to:
Additionally, the exploratory aim of this study is to determine if common factors, like credibility of the intervention and expectations to improve, can lead to symptom change.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | Experimental: Breathing exercise + active elements 1, 2, 3 In this arm, all three factors are set to active (i.e. yes):
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| Arm 2 | Experimental | Experimental: Breathing exercise + active elements 1, 2 In this arm, two factors are set to active (i.e. yes):
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| Arm 3 | Experimental | Experimental: Breathing exercise + active elements 1, 3 In this arm, two factors are set to active (i.e. yes):
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| Arm 4 | Experimental | Experimental: Breathing exercise + active elements 2, 3 In this arm, two factors are set to active (i.e. yes):
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Psychoeducation | Behavioral | Psychoeducation is a potential active element of Project ABC. In psychoeducation, participants learn about the cognitive model of behavior and how they can take action to change their moods. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-8 | 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-week post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-8 | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Credibility/Expectancy questionnaire | Two questions from Credibility/Expectancy questionnaire will be used: "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?" Participants will be asked to answer the questions on a scale of 1 (Not at all) to 9 (Very much). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jessica L Schleider | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | 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 all the planned analyses have been completed by the investigators.
Data and code will be made available here (https://osf.io/xbpsj/) upon publication of trial results.
Will be decided on a case-by-case basis
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | May 1, 2024 | May 2, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D003863 | Depression |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D001945 | Breathing Exercises |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D026241 | Exercise Movement Techniques |
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Participants will be randomized to one of 8 different conditions (factorial trial), following the Multiphase optimization Strategy (MOST)
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Participants will be aware that they will be assigned to an intervention designed to help them with depressive symptoms. Participants will be aware that there are other arms of the study to which other participants are randomized, but they will not be aware of what these other arms entail. Additionally, the measures will be self-administered, so there is no scope for evaluator bias.
| Arm 5 | Experimental | Experimental: Breathing exercise + active element 1 In this arm, one factor is set to active (i.e. yes): • Psychoeducation |
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| Arm 6 | Experimental | Experimental: Breathing exercise + active element 2 In this arm, one factor is set to active (i.e. yes): • Testimonials and Saying is believing exercises |
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| Arm 7 | Experimental | Experimental: Breathing exercise + active element 3 In this arm, one factor is set to active (i.e. yes): • Action planning |
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| Arm 8 | Experimental | Experimental: Breathing exercise only In this arm, none of the three factors are set to active (i.e. yes) |
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| Testimonials and Saying is believing exercises | Behavioral | Testimonials and Saying is believing exercises is a potential active element of Project ABC. In this element, participants learn about how others have taken action to improve their mood and complete one exercise where they give advice to a virtual peer who is stuck in a negative spiral. |
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| Action planning | Behavioral | Action planning is a potential active element of Project ABC. In this element, participants plan in detail an action they can take to get out of the negative mood spiral. |
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| Breathing exercise | Behavioral | Participants will be presented with a one-minute breathing exercise. |
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| Baseline to 2-week post-intervention |
| Beck Hopelessness Scale-4 | Beck Hopelessness Scale-4 is the 4-item version of the 20-item Beck Hopelessness scale. 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 immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention |
| Balanced measure of Psychological Needs scale | The BMPN is used as a measure of the psychological needs of autonomy, relatedness, and competence as laid out by the Self-Determination Theory. It is an 18-item questionnaire where each item is rated on a scale of 1 (Strongly disagree) to 5 (Strongly agree). Scores corresponding to each psychological need will be calculated based on the items corresponding to that need. A higher score on the three needs indicates higher wellbeing. In this study, we will use a 6-item version of the scale. | Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention |
| Baseline and immediate post-intervention; The second question will also be asked at 2-week post-intervention |
| Intervention satisfaction star rating at post-intervention | Participants will be asked to rate 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. | Immediate 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. |
| Background | Sheldon, K.M., Hilpert, J.C. The balanced measure of psychological needs (BMPN) scale: An alternative domain general measure of need satisfaction. Motiv Emot 36, 439-451 (2012). https://doi.org/10.1007/s11031-012-9279-4 |
| 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. |
| D026741 |
| Physical Therapy Modalities |