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Completed

NCT Number: NCT06322849

Active Elements of Digital Single-session Interventions

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.

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Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern University

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

  • 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

Treatment and study plan

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.

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.

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.

BREATHING EXERCISE

Behavioral

Participants will be presented with a one-minute breathing exercise.

Primary outcomes

  1. Patient Health Questionnaire-8

    Time frame: 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 outcomes

  1. Patient Health Questionnaire-8

    Time frame: 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.

  2. Beck Hopelessness Scale-4

    Time frame: 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.

  3. Balanced measure of Psychological Needs scale

    Time frame: 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 outcomes

  1. Credibility/Expectancy questionnaire

    Time frame: 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).

  2. Intervention satisfaction star rating at post-intervention

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Factorial Trial Designed to Identify Active Elements of a Self-administered Digital Single-session Intervention Targeting Depressive Symptoms.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 21, 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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