Active Elements of Digital Single-session Interventions

NCT06322849 | Completed

• 1 other identifier: STU00220591
• Study Type: interventional
• Target: 887
• Locations: 1 country
• Sites: 1

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. 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. 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. 3.calculate the main and interaction effects of the candidate components on measures of hopelessness, autonomy, relatedness, and competence.
4. 4.determine if the effects of the candidate components on PHQ-8 are mediated by measures of autonomy, relatedness, and competence.

Conditions

Depression

Keywords

Active elements; Factorial trial; Single-session interventions; Depression

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Patient Health Questionnaire-8

  Baseline to 2-week post-intervention

• Beck Hopelessness Scale-4

  Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention

• Balanced measure of Psychological Needs scale

  Baseline to immediate post-intervention; Baseline to 2-week post-intervention; Baseline to 8-week post-intervention

Other Outcomes (2)

• Credibility/Expectancy questionnaire

  Baseline and immediate post-intervention; The second question will also be asked at 2-week post-intervention

• Intervention satisfaction star rating at post-intervention

  Immediate post-intervention

Study Arms (8)

Arm 1

EXPERIMENTAL

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

Behavioral: Psychoeducation; Behavioral: Testimonials and Saying is believing exercises; Behavioral: Action planning; Behavioral: Breathing exercise

Arm 2

EXPERIMENTAL

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

Behavioral: Psychoeducation; Behavioral: Testimonials and Saying is believing exercises; Behavioral: Breathing exercise

Arm 3

EXPERIMENTAL

Experimental: Breathing exercise + active elements 1, 3 In this arm, two factors are set to active (i.e. yes): * Psychoeducation * Action planning

Behavioral: Psychoeducation; Behavioral: Action planning; Behavioral: Breathing exercise

Arm 4

EXPERIMENTAL

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

Behavioral: Testimonials and Saying is believing exercises; Behavioral: Breathing exercise

Arm 5

EXPERIMENTAL

Experimental: Breathing exercise + active element 1 In this arm, one factor is set to active (i.e. yes): • Psychoeducation

Behavioral: Psychoeducation; Behavioral: Breathing exercise

Arm 6

EXPERIMENTAL

Experimental: Breathing exercise + active element 2 In this arm, one factor is set to active (i.e. yes): • Testimonials and Saying is believing exercises

Behavioral: Testimonials and Saying is believing exercises; Behavioral: Breathing exercise

Arm 7

EXPERIMENTAL

Experimental: Breathing exercise + active element 3 In this arm, one factor is set to active (i.e. yes): • Action planning

Behavioral: Action planning; Behavioral: Breathing exercise

Arm 8

EXPERIMENTAL

Experimental: Breathing exercise only In this arm, none of the three factors are set to active (i.e. yes)

Behavioral: Breathing exercise

Interventions

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.

Arm 1; Arm 2; Arm 3; Arm 5

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.

Arm 1; Arm 2; Arm 4; Arm 6

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.

Arm 1; Arm 3; Arm 7

Breathing exercise BEHAVIORAL

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

Arm 1; Arm 2; Arm 3; Arm 4; Arm 5; Arm 6; Arm 7; Arm 8

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (5)

• 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.

  PMID: 34887544 BACKGROUND

• 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.

  PMID: 18752852 BACKGROUND

• 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.

  PMID: 23756722 BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 11132119 BACKGROUND

MeSH Terms

Conditions

Depression

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Jessica L Schleider

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Northwestern University

Model Details: Participants will be randomized to one of 8 different conditions (factorial trial), following the Multiphase optimization Strategy (MOST)

Study Record Dates

• First Submitted: March 10, 2024
• First Posted: March 21, 2024
• Study Start: May 2, 2024
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data and code will be made available here (https://osf.io/xbpsj/) upon publication of trial results.
• Access Criteria: Will be decided on a case-by-case basis

Locations

US (1)