Clinical trial NCT06322849: Active Elements of Digital Single-session Interventions
Official title: Factorial Trial Designed to Identify Active Elements of a Self-administered Digital Single-session Intervention Targeting Depressive Symptoms.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Active elements
Factorial trial
Single-session interventions
Depression
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2024-03-21
Enrollment: 887
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Participants will be randomized to one of 8 different conditions (factorial trial), following the Multiphase optimization Strategy (MOST)
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire-8
timeFrame: Baseline to 8-week post-intervention
Secondary outcomes:
measure: Patient Health Questionnaire-8
timeFrame: Baseline to 2-week post-intervention
measure: Beck Hopelessness Scale-4
timeFrame: Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention
measure: Balanced measure of Psychological Needs scale
timeFrame: Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention
Other outcomes:
measure: Credibility/Expectancy questionnaire
timeFrame: Baseline and immediate post-intervention; The second question will also be asked at 2-week post-intervention
measure: Intervention satisfaction star rating at post-intervention
timeFrame: Immediate post-intervention
Locations:
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
Study officials:
affiliation: Northwestern University
name: Jessica L Schleider
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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
citation: 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.