NCT05925816

Brief Summary

The purpose of the study is to evaluate the use of a text-based game as a way to understand decision making and knowledge related to anxiety, stress, and mood states like depression or loneliness. The investigators are interested in identifying whether participants who are given feedback before and during the game will report changes in behavior or depressive symptoms over the course of a one-week period. This is a follow-up to the published study from the researchers.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2022

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 14, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

June 29, 2023

Completed
Last Updated

June 29, 2023

Status Verified

June 1, 2023

Enrollment Period

3 months

First QC Date

June 14, 2023

Last Update Submit

June 22, 2023

Conditions

Depressive Symptoms

Keywords

depressive symptoms

Outcome Measures

Primary Outcomes (3)

  • patient health questionnaire (PHQ; 8 items)

    The PHQ measures depression; scores range from 0 to 24 with higher scores indicating more depression.

    baseline (T0) - before intervention

  • patient health questionnaire (PHQ; 8 items)

    The PHQ measures depression; scores range from 0 to 24 with higher scores indicating more depression.

    one week following intervention (T1)

  • Behavior in study-specific game

    For participants completing the game (neutral or active), behavior and choices made will be used as data for analyses. Game choices allow participants to decide what next activities they will "do" in the game. Analyses incorporate decision probabilities (which of 2-5 choices are selected) and compare them between conditions. The game is completed at baseline following assessment (and following video) for those assigned this arm only.

    Completed at baseline (T0)

Secondary Outcomes (2)

  • Generalized Anxiety Disorder 7 (GAD-7)

    Baseline (T0) before intervention

  • Generalized Anxiety Disorder 7 (GAD-7)

    one-week follow-up (T1)

Study Arms (6)

Video

EXPERIMENTAL

Short video with BA intervention ideas

Behavioral: Video

Active game

EXPERIMENTAL

Feedback Twine game

Behavioral: Active game

Neutral game

SHAM COMPARATOR

Neutral Twine game

Behavioral: Neutral game

No intervention

NO INTERVENTION

Video + Active game

EXPERIMENTAL

Combines Video and Active game

Behavioral: VideoBehavioral: Active game

Video + Neutral game

ACTIVE COMPARATOR

Combines Video and Neutral game

Behavioral: VideoBehavioral: Neutral game

Interventions

VideoBEHAVIORAL

Video uses BA techniques for approximately 5 minutes

VideoVideo + Active gameVideo + Neutral game
Active gameBEHAVIORAL

Game provides positive feedback in response to decisions made by participants

Active gameVideo + Active game
Neutral gameBEHAVIORAL

Game without feedback

Neutral gameVideo + Neutral game

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • + age
  • Eligible to participate in online research
  • Able to read and respond in English

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bard College

Annandale-on-Hudson, New York, 12504, United States

Location

MeSH Terms

Conditions

Depression

Interventions

Videotape Recording

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Tape RecordingAudiovisual AidsEducational TechnologyTechnologyTechnology, Industry, and AgricultureTelevision

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Brief interventions are conducted online and thus largely masked. All assessment is also conducted through an online survey.
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Psychology

Study Record Dates

First Submitted

June 14, 2023

First Posted

June 29, 2023

Study Start

February 2, 2022

Primary Completion

May 4, 2022

Study Completion

May 4, 2022

Last Updated

June 29, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will share

Data and code for analyses have been shared on the Open Science Framework, https://osf.io/

Shared Documents
STUDY PROTOCOL, ANALYTIC CODE
Time Frame
IPD will be available when the study is submitted for publication, beginning in 2023.
Access Criteria
Anyone will be able to access de-identified data and code.
More information

Locations

US(1)