Depression
Conditions
Keywords
Active elements, Factorial trial, Single-session interventions, Depression
Brief summary
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: 1. calculate the main effects of the candidate components-psychoeducation, testimonials + saying is believing exercises, and action planning-on PHQ-8 scores at immediate post-treatment and 2-week follow-up. 2. calculate the interaction effects, if any, among the candidate components on PHQ-8 scores at immediate post-treatment, 2-week, and 8-week follow-up. 3. calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence. 4. determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence. 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.
Interventions
BEHAVIORALPsychoeducation
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.
BEHAVIORALTestimonials and Saying is believing exercises
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.
BEHAVIORALAction planning
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.
BEHAVIORALBreathing exercise
Participants will be presented with a one-minute breathing exercise.
Sponsors
Northwestern University
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
Participants will be randomized to one of 8 different conditions (factorial trial), following the Multiphase optimization Strategy (MOST)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Located in the United States * Baseline Patient Health Questionnaire-8 (PHQ-8) score \>= 10 * Able to read and write English * Able to access to the internet via a computer, tablet or smartphone for the next eight weeks
Exclusion criteria
* Participants who have participated in another related study on depression from our laboratory via the same participant recruitment platform in the past two months * Participants who have submitted gibberish in open response questions
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-8 | Baseline to 8-week 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire-8 | Baseline to 2-week 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. |
| Beck Hopelessness Scale-4 | Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention | 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. |
| Balanced measure of Psychological Needs scale | Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Credibility/Expectancy questionnaire | Baseline and immediate post-intervention; The second question will also be asked at 2-week post-intervention | 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). |
| Intervention satisfaction star rating at post-intervention | Immediate 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. |
Countries
United States
Outcome results
None listed