跳至主要内容
临床试验/NCT04007900
NCT04007900已完成不适用

Positive Affect Treatment (PAT) to Target Reward Mechanisms in Anorexia Nervosa

University of Minnesota2 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年5月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
25
试验地点
2
主要终点
Efficacy: Change in BMI

研究概览

简要总结

The goal of the proposed research is to determine the extent to which Positive Affect Treatment (PAT), a novel treatment targeting reward mechanisms, can effectively target the psychological reward deficits that maintain anorexia nervosa (AN), and thus improve clinical symptoms.

详细描述

Anorexia Nervosa is a serious disorder associated with high medical and psychiatric morbidity, poor quality of life, and the highest mortality rate of any psychiatric illness. Although many individuals with AN ultimately achieve remission, this process of recovery is slow, with only about 1/3 of individuals recovering in the first decade of illness, and is not always associated with an enhanced quality of life. Further, a substantial portion of those with AN do not recover; 20-30% of affected individuals maintain a chronic illness course or die prematurely. Interventions that enhance the probability of long-term remission from adult AN are lacking. Efficacious outpatient treatments have not been identified and, although inpatient treatment can restore healthy weight, up to 50% of patients with AN relapse within a year of discharge. This paucity of effective treatment may be due to existing interventions not targeting key mechanisms of the disorder. Advances in neuroscience have contributed promising insights about the processes that promote AN symptoms. However, these findings have not been adequately integrated into treatment for AN. It is critical that future treatment development utilize emerging research on the mechanisms of AN to develop more effectively targeted interventions. The goal of the proposed research is to determine the extent to which Positive Affect Treatment (PAT), a novel treatment targeting reward mechanisms, can effectively target the psychological reward deficits that maintain anorexia nervosa (AN), and thus improve clinical symptoms. To this end, we propose a small, randomized, wait-list controlled pilot trial of PAT adapted for AN (PAT-AN) to achieve the following aims: To asses the feasibility and acceptability of PAT-AN among individuals with AN and to obtain initial data regarding the potential efficacy of PAT-AN compared to waitlist control on measures of clinical outcome and putative reward mechanisms in AN to inform a future larger randomized, controlled trial of this intervention.

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
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • DSM-5 diagnosis of AN (established by the adapted MINI)
  • Ability to read and speak in English
  • Involvement in ongoing oversight with a primary physical or mental health provider as defined by:
  • Identification by the participant of a physical or mental health provider (e.g., physician, psychiatrist, psychologist, masters level social worker, licensed professional clinical counselor, licensed marriage and family therapist) who will serve as the primary provider throughout the study
  • Willingness to sign a Release of Information that gives the study therapist the right to discuss any change in medical or psychiatric stability or other health concerns with the participant's identified primary provider.

排除标准

  • Medical instability according to standard guidelines and medical staff judgment
  • Acute suicidality, current substance use disorder, psychosis, or mania requiring specialized treatment
  • Lacking capacity to consent
  • Current pregnancy

结局指标

主要结局

Efficacy: Change in BMI

时间窗: 20-weeks

Body mass index (BMI) will be calculated based on height and weight measure by a stadiometer and calibrated scale during a medical examination. Change in BMI (kg/m2) will be calculated from baseline to 20-weeks. Increase in BMI in the treatment group vs control will be considered a measure of efficacy of the treatment.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

Loading locations...

相似试验

Positive Affect Treatment (PAT) to Target Reward... | 临床试验