Active Elements of Digital Single-session Interventions

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06322849
• Other study ID #: STU00220591
• Status: Recruiting
• Phase: N/A
• Start date: May 2, 2024
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: Northwestern University
• Contact: Jessica L Schleider, PhD
• Phone: (917) 439-1872
• Email: jessica.schleider[@]northwestern.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 880
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression

Intervention

Behavioral:
• Psychoeducation
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
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
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
Participants will be presented with a one-minute breathing exercise.

Locations

Country	Name	City	State
United States	Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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).	Baseline and immediate post-intervention; The second question will also be asked at 2-week post-intervention
Other	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
Primary	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
Secondary	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 2-week post-intervention
Secondary	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
Secondary	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