Clinical trial NCT05601362: Evaluation of a Therapeutic Mobile App for Depression
Official title: Evaluation of a Therapeutic Mobile App for Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: University of Texas at Austin
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient Health Questionnaire - 8 (PHQ-8)
timeFrame: Baseline to Treatment End (4 weeks)
Secondary outcomes:
measure: Ruminative Response Scale - Brooding subscale (RRS-B)
timeFrame: Baseline to Treatment End (4 weeks)
measure: Perseverative Thinking Questionnaire (PTQ) -"Difficult to Disengage from" subscale
timeFrame: Baseline to Treatment End (4 weeks)
measure: Inventory of Depression and Anxiety Symptoms (IDAS) Dysphoria subscale
timeFrame: Baseline to Treatment End (4 weeks)
Other outcomes:
measure: Attention bias (mousetracking)
timeFrame: Weekly assessment over 4 weeks
measure: General Rumination
timeFrame: daily over 4 weeks
Locations:
city: Austin
country: United States
facility: Mary Eileen McNamara
state: Texas
Study officials:
References: