Randomized Controlled Trial for Personalized Need-focused Single-Session Interventions
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 240
- 试验地点
- 2
- 主要终点
- Hamilton-Anxiety Rating Scale
研究概览
简要总结
This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis.
详细描述
This is a two-site randomized controlled trial, with two goals. First, the investigators aim to demonstrate that single-session interventions for mild-to-moderate anxiety and depression can generate statistically significant symptom change as a main effect across control and experimental (i.e. personalized) conditions. Second, the investigators hope to establish the additional incremental efficacy of personalization via person-specific intensive longitudinal data collection and analysis.
All single-session interventions will be 90-minutes in length. At the conclusion of the intervention session, participants will receive suggestions for daily homework practice to complete and a flash drive with a copy of their session audio to review at their discretion. Participants will also meet with the therapist for a 10-minute remote check-in two weeks following the single session.
All interventions include standard psychoeducational components. Participants randomized to the personalization arm of the study will be given an intervention matched to their most pressing psychosocial need. Participants randomized to the control condition will receive a standard intervention (at the UCB site) or a randomly selected one (at the BIU site). Both the standard intervention and the specific ones were designed to be broadly efficacious for depression and anxiety symptomatology.
The psychosocial needs which serve as the focus of the interventions are derived from motivation and affect regulation models and include emotional stability, predictability, acceptance, competence, self-esteem, autonomy, and pleasure. The primary unmet need for each individual will be determined by a conditional entropy algorithm. Simply, the presence versus absence of subjective distress will be measured eight times per day for 30 days. Concurrently, the presence versus absence of need frustration will also be measured eight times per day for 30 days. Utilizing a k-fold cross-validated estimation, conditional entropy will be used to determine the need that best reduces the uncertainty in subjective distress (that is, best explains its presentation probabilistically).
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
The participants and any care provider and study personnel who interact with them will be blind to condition. The PI will utilize a randomization table to allocate participants to condition, and will inform the front-line study personnel and through them, the care provider, regarding which intervention to use without specifying whether it was personalized or randomly-chosen. The outcomes assessor will be blind even to the type of intervention utilized.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criterion.
- •* a score of 5 or above on the Hamilton Rating Scale for Depression (HRSD).
排除标准
- •based on Diagnostic Interview for DSM-5 Anxiety, Mood, and Obsessive-Compulsive and Related Disorders (DIAMOND).
- •Psychotic Disorders (hallucinations or delusions)
- •Past or current mania, current hypo-mania.
- •Anorexia Disorder
- •Current Obsessive-Compulsive and related Disorders rated as moderate and above.
- •Alcohol or drug abuse rated as moderate and above.
- •Panic Disorder rated as moderate and above.
- •Agoraphobia rated as moderate and above.
- •Premenstrual dysphoric disorder rated as moderate and above.
- •Current Post-Traumatic Stress Disorder rated as moderate and above.
- •binge eating rated as moderate and above.
- •Phobia rated as severe and above.
- •Somatic symptom disorder rated as severe and above.
- •Illness Anxiety Disorder rated as severe and above.
- •MDD rated as severe and above.
- •GAD rated as severe and above.
- •Social Anxiety rated as severe and above.
- •Separation anxiety rated as severe and above.
研究组 & 干预措施
Personalized Intervention
The intervention approach taken in this RCT is focused on unmet psychological needs (predictability, belonging, competence, self-worth, autonomy, and playfulness). For each need, a specific 90-minute intervention has been developed.
The primary unmet need for each individual will be determined by a conditional entropy algorithm. Simply, the presence versus absence of subjective distress will be measured eight times per day for 30 days. Concurrently, the presence versus absence of need frustration will also be measured eight times per day for 30 days. Utilizing a k-fold cross-validated estimation, conditional entropy will be used to determine the need that best reduces the uncertainty in subjective distress (that is, best explains its presentation probabilistically).
At both sites, the experimental condition will consist of an algorithmically-chosen intervention. The choice will be made based on data collected during thirty days of ecological momentary assessment.
干预措施: Clinician-administered Need-focused Single Session Intervention (Behavioral)
Non-personalized Intervention
The intervention approach taken in this RCT is focused on unmet psychological needs (predictability, belonging, competence, self-worth, autonomy, and playfulness). For each need, a specific 90-minute intervention has been developed.
At the BIU site, the active control condition will consist of an intervention chosen randomly (out of the six mentioned above).
At the UCB site, the active control condition will consist of a standard intervention addressing emotion regulation difficulties.
干预措施: Clinician-administered Need-focused Single Session Intervention (Behavioral)
结局指标
主要结局
Hamilton-Anxiety Rating Scale
时间窗: Change between pre-intervention and 1 month post-intervention
(Range 0-56, higher scores denote greater anxiety); will be used in lieu of Hamilton-Depression ratings for individuals whose Hamilton-Anxiety scores are higher than their Hamilton-Depression scores.
Hamilton-Depression Rating Scale
时间窗: Change between pre-intervention and 1 month post-intervention
(Range 0-52, higher scores denote greater depression)
Montgomery-Asberg Depression Rating Scale
时间窗: Change between pre-intervention and 1 month post-intervention
(Range 0-60, higher scores denote greater depression)
次要结局
- PHQ-8(Immediately prior to intervention, and again at 1 and 3 months post-intervention)
- GAD-7(Immediately prior to intervention, and again at 1 and 3 months post-intervention)
- DASS(Immediately prior to intervention, and again at 1 and 3 months post-intervention)
研究者
Prof. Eshkol Rafaeli
Professor
Bar-Ilan University, Israel