跳至主要内容
临床试验/NCT06361095
NCT06361095招募中早期 1 期

Confirmatory Efficacy Trial of a Traditional vs. Gamified Attention Bias Modification for Depression

University of Texas at Austin2 个研究点 分布在 1 个国家目标入组 600 人开始时间: 2024年5月1日最近更新:
适应症

试验速览

阶段
早期 1 期
状态
招募中
入组人数
600
试验地点
2
主要终点
QIDS (Quick Inventory of Depression Symptoms) SR-16

研究概览

简要总结

The goal of this clinical trial is to compare the efficacy of two related, but different ABM (Attention Biased Modification) treatments for depression in adults with elevated symptoms of depression. The main aims are:

  • Aim 1:examine whether gamified ABM leads to greater change in the primary and secondary outcomes than sham ABM
  • Aim 1: establish that gamified ABM is at least as effective as traditional ABM.
  • Aim 2: identify moderators of ABM efficacy and mechanisms responsible for its efficacy.
  • Aim 3: Identify the durability of ABM on depression symptoms during short-term follow-up

Participants will complete self-report questionnaires, complete eye-tracking tasks, and be clinically assessed through interviews by clinician researchers.

If there is a comparison group: Researchers will compare sham, traditional, and gamified treatment groups to see if they moderate symptoms of depression.

详细描述

The overall goal of this project is to conduct a well-powered confirmatory efficacy trial comparing a gamified, attention bias modification (ABM) mobile application and traditional ABM to sham ABM among adults with elevated symptoms of depression. The proposed R01 efficacy trial follows the NIMH intervention development sequence as it builds upon prior NIMH-funded experimental therapeutics work, specifically R21MH092430 "Attention training for Major Depressive Disorder" and R33MH109600 "Development of attention bias modification for depression". This prior work demonstrates that active ABM engages and alters negative attention bias and there is a preliminary efficacy signal that ABM reduces depression. Although traditional ABM is efficacious for the treatment of depression, "gamified" forms of ABM have the potential to be more accessible and engaging than traditional ABM. Pilot work suggests that a gamified ABM can reduce negative affect; however, its effectiveness for depression has not yet been established. Thus, investigators are proposing to conduct a well-powered, confirmatory efficacy trial to determine ABM's potential for the treatment of depression. In Aim 1, the investigators will examine the efficacy of ABM in a large sample of adults (N = 600) with elevated symptoms of depression. The investigators hypothesize that gamified and traditional ABM will lead to significantly greater reductions in self-reported and interviewer-rated depression symptoms than sham ABM. The investigators further hypothesize that traditional ABM will be non-inferior to gamified ABM (treatment superiority between the ABM conditions will also be tested). In Aim 2, the investigators will examine putative moderators and mediators of ABM. Based on ABM research with anxious populations, it is predicted that people with a strong initial attentional bias for sad stimuli will experience greater reductions in depression in response to either gamified or traditional ABM than sham ABM. In terms of mediation, compared to sham ABM, the investigators hypothesize that gamified and traditional ABM will: (1) decrease negative attentional bias measured behaviorally with reliable eye tracking methods; (2) significantly reduce depression; and (3) improve depression symptoms via their influence on negative attentional bias. Selection of the putative mediators is informed by our prior R33 ABM trial, where it was found that gaze bias away from sad stimuli mediated the effect of traditional ABM on depression symptom change. In Aim 3, an exploratory aim, the investigators will estimate the durability of ABM by collecting post-treatment symptom data 1-, 2-, 3-, and 6-months after ABM completion. Symptom change and reliable recovery across a six-month follow-up period will be estimated. Currently, the durability of ABM effects for depression is unknown, as few well-powered ABM studies for depression have obtained follow-up data. This trial would provide the most definitive data to date regarding whether ABM for depression is a promising treatment for depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Provided informed consent
  • Fluent in English
  • Scored 13 or greater on the QIDS-SR at the baseline assessment
  • Between the ages of 18 to 70
  • Have had no changes in medication and dosage in the past 12 weeks (if currently on antidepressant medication)

排除标准

  • Reported suicidal behavior or significant suicidal ideation within the past six months using the Columbia-Suicide Severity Rating Scale (C-SSRS)
  • Met criteria for current or past bipolar or psychotic disorders
  • Current (i.e., within the past 12 months) substance use disorders of moderate or greater severity on the Mini International Neuropsychiatric Interview (MINI)
  • Currently taking opioid analgesics or systemic corticosteroid use as these medications
  • Currently receiving psychotherapy

结局指标

主要结局

QIDS (Quick Inventory of Depression Symptoms) SR-16

时间窗: Screening, Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period)

The Quick Inventory of Depressive Symptoms (QIDS) is a 16-item measure (self-report and clinician-rated versions) for adults with depression with solid psychometric properties and substantial data supporting sensitivity to change. The QIDS assesses the criterion domains used to diagnose a major depressive disorder. The participant must score a minimum of 13 on the QIDS-SR at the baseline assessment to qualify for participation. Total QIDS scores range from 0 to 27, with higher scores reflecting greater severity of depression, and thus, worst outcomes for our study.

次要结局

  • Hamilton Depression Rating Scale (HAM-D)(Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period))
  • Snaith-Hamilton Pleasure Scale (SHAPS)(Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period))
  • Perseverative Thinking Questionnaire (PTQ)(Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period))
  • Sheehan Disability Scale (SDS)(Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period))
  • Generalized Anxiety Disorder (GAD-7)(Baseline, Weeks 1-4 (Acute Period), Weeks 12-28 (Follow-Up Period))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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