Behavioral Study to Predict the Efficacy of a Self-Help Tool

NCT06631183 | Active Not Recruiting

• 1 other identifier: 15118
• Study Type: interventional
• Target: 1,500
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to examine whether the investigators can predict, on the level of individual participants who have symptoms of depression, who will benefit more from self-help tools based on principles of behavioral activation vs. cognitive restructuring, in terms of a greater decrease of self-reported symptoms. The investigators use a combination of self-reported clinical information and behavior on learning and decision-making tasks to predict change in symptom scores.

Conditions

Self-reported Symptoms of Depression

Outcome Measures

Primary Outcomes (2)

• Predictive accuracy of sum of self-reported depression symptoms (assessed with Patient Health Questionnaire) after engagement with self-help tool using behavioral tasks

  Participants will be randomized to a discovery or validation datasets with a ratio of 2:1. Prior to analyzing the validation dataset, the investigators will pre-register the precise analyses based on the results from the discovery dataset. Participants complete several behavioral tasks focusing on learning and decision-making prior to start of the engagement with the self-help tool. Self-reported depression symptom scores are assessed with the Patient Health Questionnaire (PHQ-9, sum ranges from 0-27, higher scores indicate more symptoms of depression). The investigators will predict change in depression symptoms based on modeled task data and then verify the results in pre-registered analyses of the validation dataset.

  approx. 6 weeks

• Predictive accuracy of sum of self-reported anhedonia symptoms (assessed with Snaith-Hamilton Pleasure scale) after engagement with self-help tool using behavioral tasks

  Participants will be randomized to a discovery or validation datasets with a ratio of 2:1. Prior to analyzing the validation dataset, the investigators will pre-register the precise analyses based on the results from the discovery dataset. The participants complete several behavioral tasks focusing on learning and decision-making prior to start of the engagement with the self-help tool. Self-reported symptoms scores of anhedonia will be assessed with the Snaith-Hamilton Pleasure Scale (SHAPS, sum score range from 14-56, higher scores indicate more anhedonia). The investigators will predict change in anhedonia symptoms based on task data and then verify the results in pre-registered analyses of the validation dataset.

  approx. 6 weeks

Study Arms (2)

Behavioral activation group

EXPERIMENTAL

Participants will read information and engage in exercises through the self-help tool e-couch that aim at stimulating their engagement in pleasant activities.

Behavioral: Self-help information based on principles of behavioral activation

Cognitive restructuring group

EXPERIMENTAL

Participants will read information and engage in exercises through the self-help tool e-couch that aim at tackling negative thinking.

Behavioral: Self-help information based on principles of cognitive restructuring

Interventions

Self-help information based on principles of behavioral activation BEHAVIORAL

Participants will engage with the self-help tool e-couch (https://ecouch.com.au). In the first week, they will complete the depression information submodule from the depression program. Over the following four weeks, they will complete submodules on behavioral activation and physical activity.

Behavioral activation group

Self-help information based on principles of cognitive restructuring BEHAVIORAL

Participants will engage with the self-help tool e-couch (https://ecouch.com.au). In the first week, they will complete the depression information submodule from the depression program. Over the following four weeks, they will complete submodules on cognitive restructuring.

Cognitive restructuring group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Fluent in English
• The primary mental health concern participants want to work on must be that they would like to improve their mood, to reduce negative thoughts, to enjoy more activities again and/or to reduce symptoms of depression
• Having a picture ID and be willing to meet with us on a video zoom call for identity verification if invited to do so

You may not qualify if:

• Lack of attention when completing parts of the study, lack of honesty or not completing parts of the study in a timely way
• Identity check failure

Sponsors & Collaborators

• Trustees of Princeton University: lead

Study Sites (1)

Princeton Neuroscience Institute, but recruitment and study are conducted completely online and can occur anywhere in the US.

Princeton, New Jersey, 08540, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants engage with a self-help online tool that provides information on depression and skills to deal with symptoms of depression. Outcomes are self-reported symptoms and behavioral task data collected from participants online. No humans are involved in providing care or outcome assessment of the study; instead, these parts are executed by computer software. Thus, the care provider and the outcome assessor are considered to be masked.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2024
• First Posted: October 8, 2024
• Study Start: January 23, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: Within one year after study completion, some data may be shared earlier.
• Access Criteria: Upon reasonable request and providing that the requesters will treat the data in line with the researchers' ethical principles. Researchers may also make de-identified data publicly available.

Locations

US (1)