Evaluation of a Therapeutic Mobile App for Depression

Depression Clinical Trial

Official title:

Evaluation of a Therapeutic Mobile App for Depression

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05601362
• Other study ID #: STUDY00003315
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 30, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: August 2023
• Source: University of Texas at Austin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is a preliminary evaluation of a gamified attention bias modification training (GAMBT) for reducing symptoms of depression and rumination. Individuals with elevated symptoms of depression will use the digital intervention over the course of 4 weeks. They will complete a brief (~5 question) survey daily, as well as weekly assessments.

Description:

This study aims to assess the feasibility and efficacy of the digital therapeutic attention bias modification (ABM) intervention that targets and reduces negative attention bias among adults with elevated symptoms of depression. Consistent with the experimental therapeutics approach ABM has been shown to both reduce negative attention bias and improve symptoms of depression. However, engagement with these tasks have been mixed, with some participants describing traditional ABM tasks as boring. This had led to the development of gamified versions of ABM with the intent to improve participant engagement. Nevertheless, there have been very few rigorous trials of ABM for depression, and no one to our knowledge has used ecological momentary assessment to tease apart the mechanisms by which ABM can lead to improvements in depression symptoms.

Participants will access the intervention on their mobile smart phone and complete treatment over a period of 4 weeks. Enrolled participants will be randomly assigned to one of two groups: Gamified attention bias modification training, or gamified placebo training. They will complete brief (~5 questions) daily surveys, as well as weekly remote assessments of attention bias and depression symptoms.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 110
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• able and willing to provide informed consent;

• fluent in English;

• normal or corrected-to-normal vision

• moderate or greater depression symptoms (defined as greater than or equal to 10 on the PHQ-8);

• attention bias for negative stimuli (operationalized as greater than an average of 6500 ms of dwell time on sad faces in an attention bias task);

• stable psychiatric and neurological medication usage.

• access to a smartphone for downloading the app and a laptop or desktop computer to complete the weekly assessments

Exclusion Criteria:

• recent heavy alcohol use defined as a score of 2 or higher on the PDSQ

• past or present comorbidity of other serious mental illness (e.g., schizophrenia, substance use disorder, bipolar disorder, etc.)

• previous experience with gamified attention bias modification app

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Device:
• Gamified Attention Bias Modification
Gamified computerized behavioral therapy with therapeutic intervention based on Attention Bias Modification Training (ABMT).
• Gamified Placebo Training
Placebo version of Gamified Attention Bias Modification. (Identical version of the gamified behavioral intervention without manipulation designed to decrease negative attention bias).

Locations

Country	Name	City	State
United States	Mary Eileen McNamara	Austin	Texas

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas at Austin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attention bias (mousetracking)	Change in scan time for viewing sad stimuli assessed via mousetracking	Weekly assessment over 4 weeks
Other	General Rumination	Change in rumination (assessed via smartphone-delivered ecological momentary assessment items used in prior EMA research (Smith et al., 2021)). (Range: 4-20, higher scores indicate more rumination)	daily over 4 weeks
Primary	Patient Health Questionnaire - 8 (PHQ-8)	8-item self-report measure of depression symptom severity (Range: 0-24, higher scores indicate greater depression severity)	Baseline to Treatment End (4 weeks)
Secondary	Ruminative Response Scale - Brooding subscale (RRS-B)	5-item self-report measure of rumination frequency (Range: 1-20, higher scores indicate more rumination)	Baseline to Treatment End (4 weeks)
Secondary	Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage from" subscale	3-item self-report measure of rumination frequency (Range: 0-12, higher scores indicate more rumination)	Baseline to Treatment End (4 weeks)
Secondary	Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria subscale	10-item measure of dysphoria and depression symptoms (Range: 10-50, higher scores indicate greater dysphoria)	Baseline to Treatment End (4 weeks)