Technology dRiven Enhancement to Engage & Connect
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Acceptability (Client Satisfaction Questionnaire; CSQ)
研究概览
简要总结
This study will investigate whether an intervention that includes remotely delivered therapy sessions and a digital mental health app, compared to only remotely delivered therapy reduces late-life depression
详细描述
Depression in mid- and late-life is characterized with reduced functions of the reward system. The investigators designed a psychotherapy that aims to improve reward functions through engagement in pleasurable activities and in turn reduce depression. Prior work has shown that this therapy is acceptable and reduces depression. This study examines whether a hybrid intervention that combines clinician remotely-delivered psychotherapy, and a novel app named TREE-Connect, reduces late life depression. This TREE-Connect app uses a machine learning algorithm to promote adherence to therapy (completion of therapeutic homework) in late-life depression and increase cost-effectiveness and reach of treatment to older adults. This randomized controlled trials will test whether the hybrid intervention (clinician-delivered psychotherapy + app), compared to a condition that includes solely clinician-delivered therapy is acceptable and reduces late-life 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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 50-80
- •Capacity to provide consent for research assessment and treatment.
- •Significant depression, i.e., PHQ-9 ≥ 7 (mild-moderate severity of symptoms)
- •Mini Mental Status Exam (MMSE) equal or greater than a score of
- •Off antidepressants or on stable dose for 8 weeks and do not intend to change the dose in the next 10 weeks, without individual psychotherapy services during the study period.
排除标准
- •Intent or plan to commit suicide in the near future.
- •Inability to communicate in English.
- •History or presence of psychiatric diagnoses other than major depressive disorder without psychotic features, generalized anxiety disorder, specific phobia, or antisocial or borderline personality disorder.
- •Neurological disorders (dementias, amnestic and multidomain Mild Cognitive Impairment, Parkinson's disease, epilepsy, etc.).
- •Acute or severe medical illness in the past 3 months (metastatic cancer, multiple sclerosis, decompensated cardiac, liver or kidney failure, major surgery, stroke or myocardial infarction, cardiac, renal, or respiratory failure; severe chronic obstructive pulmonary disease, etc.) that may be the primary cause depressive symptoms, influence brain systems of interest, or impact ability to participate in the study.
- •For MRI only: Contraindications to MRI scanning including cardiac pacemaker, heart valve replacement, vascular stent, insulin pump, cochlear implant, any other metallic biomedical implant contraindicating to MRI, and claustrophobia.
研究组 & 干预措施
Clinician-delivered psychotherapy
Participants will receive clinician-delivered psychotherapy without the TREE-Connect app
干预措施: Clinician-delivered psychotherapy (Behavioral)
TREE-Connect + Clinician-delivered psychotherapy
Participants will receive a hybrid intervention that includes clinician-delivered psychotherapy and a TREE-Connect app
干预措施: TREE-Connect (Behavioral)
TREE-Connect + Clinician-delivered psychotherapy
Participants will receive a hybrid intervention that includes clinician-delivered psychotherapy and a TREE-Connect app
干预措施: Clinician-delivered psychotherapy (Behavioral)
结局指标
主要结局
Acceptability (Client Satisfaction Questionnaire; CSQ)
时间窗: 9 Weeks
Acceptability will measured using the Client Satisfaction Questionnaire (CSQ) with a benchmar score of \>=3 (out of 4; average score); Range: 0 to 4, with higher scores indicating greater acceptability
次要结局
未报告次要终点