Active Elements of Digital Single-session Interventions
- Conditions
- Depression
- Interventions
- Behavioral: PsychoeducationBehavioral: Testimonials and Saying is believing exercisesBehavioral: Action planningBehavioral: Breathing exercise
- Registration Number
- NCT06322849
- Lead Sponsor
- Northwestern University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 887
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Arm 1 Psychoeducation Experimental: Breathing exercise + active elements 1, 2, 3 In this arm, all three factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises * Action planning Arm 1 Breathing exercise Experimental: Breathing exercise + active elements 1, 2, 3 In this arm, all three factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises * Action planning Arm 4 Testimonials and Saying is believing exercises Experimental: Breathing exercise + active elements 2, 3 In this arm, two factors are set to active (i.e. yes): * Testimonials and Saying is believing exercises * Action planning Arm 5 Psychoeducation Experimental: Breathing exercise + active element 1 In this arm, one factor is set to active (i.e. yes): • Psychoeducation Arm 7 Breathing exercise Experimental: Breathing exercise + active element 3 In this arm, one factor is set to active (i.e. yes): • Action planning Arm 7 Action planning Experimental: Breathing exercise + active element 3 In this arm, one factor is set to active (i.e. yes): • Action planning Arm 2 Testimonials and Saying is believing exercises Experimental: Breathing exercise + active elements 1, 2 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises Arm 2 Breathing exercise Experimental: Breathing exercise + active elements 1, 2 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises Arm 8 Breathing exercise Experimental: Breathing exercise only In this arm, none of the three factors are set to active (i.e. yes) Arm 1 Testimonials and Saying is believing exercises Experimental: Breathing exercise + active elements 1, 2, 3 In this arm, all three factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises * Action planning Arm 1 Action planning Experimental: Breathing exercise + active elements 1, 2, 3 In this arm, all three factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises * Action planning Arm 2 Psychoeducation Experimental: Breathing exercise + active elements 1, 2 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Testimonials and Saying is believing exercises Arm 3 Action planning Experimental: Breathing exercise + active elements 1, 3 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Action planning Arm 3 Psychoeducation Experimental: Breathing exercise + active elements 1, 3 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Action planning Arm 4 Breathing exercise Experimental: Breathing exercise + active elements 2, 3 In this arm, two factors are set to active (i.e. yes): * Testimonials and Saying is believing exercises * Action planning Arm 5 Breathing exercise Experimental: Breathing exercise + active element 1 In this arm, one factor is set to active (i.e. yes): • Psychoeducation Arm 3 Breathing exercise Experimental: Breathing exercise + active elements 1, 3 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Action planning Arm 6 Testimonials and Saying is believing exercises Experimental: Breathing exercise + active element 2 In this arm, one factor is set to active (i.e. yes): • Testimonials and Saying is believing exercises Arm 6 Breathing exercise Experimental: Breathing exercise + active element 2 In this arm, one factor is set to active (i.e. yes): • Testimonials and Saying is believing exercises
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.
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.
Trial Locations
- Locations (1)
Northwestern University
🇺🇸Chicago, Illinois, United States