Nutrition, Exercise, and Wellness Treatment (NEW Tx) for Bipolar Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Client Satisfaction Questionnaire-8
研究概览
简要总结
Cardiovascular disease (CVD) is the leading cause of morbidity and mortality in bipolar disorder, yet no empirically validated psychosocial interventions to manage risk factors for CVD in BD have been developed. The purpose of this study is to develop and test the feasibility of an integrated treatment to decrease CVD risk factors, while exploring whether the intervention improves overall functioning and mood symptoms. The designed treatment integrates theories on Nutrition strategies, Exercise interventions, and Wellness Treatment (NEW Tx) to address risk factors for CVD that co-occur with bipolar disorder. NEW Tx includes novel intervention strategies in each of these three modules, as well as modified and tailored empirically-supported strategies for bipolar disorder. The primary hypotheses are that NEW Tx will be feasible to deliver, acceptable to this population, and associated with improvements in CVD risk factors (i.e., waist circumference). Exploratory analyses will examine predictors of treatment response and the effect of NEW Tx on mood symptoms and overall functioning.
详细描述
The purpose of the Nutrition, Exercise, and Wellness Treatment (NEW Tx) research is to develop and test the feasibility and acceptance of a theoretically integrated treatment to address the impact of medical comorbidity of individuals with bipolar disorder (BD), while exploring its efficacy, whether it improves overall functioning and symptoms, as well as examine a potential moderator and mediator of treatment response.
A.Primary Aims
Aim 1: Feasibility and Acceptance of NEW Tx in the Nonrandomized Trial.
Hypothesis 1a: A preliminary study of whether NEW Tx will be feasible with regards to recruitment, retention, blinded assessments, and therapist adherence to NEW Tx.
Hypothesis 1b: Participants will report high satisfaction with the treatment and acceptability over the study duration in a nonrandomized trial.
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 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Bipolar Disorder (Type I or II), which is the primary focus of treatment
- •Ability to give informed consent
- •Currently ill (CGI-BP ≥ 3)
- •Age > 18 years and < 65 years
- •Overweight individuals (BMI > 25)
排除标准
- •Unwilling/unable to comply with study procedures
- •Endorsed item, confirmed by patient's physician, on the PAR-Q
- •Euthymic (CGI-BP < 3)
- •Diagnosis of an eating disorder (e.g., anorexia nervosa, bulimia nervosa) in the past month
- •Diagnosis of substance dependence in the past month
- •Active suicidality (MADRS item 9 score > 4)
- •Pregnant (as analyzed by a urine pregnancy test)
- •Currently receiving another psychosocial treatment
- •Exercising regularly (i.e., 5 days per week for 30 min)
- •Neurologic disorder or history of head trauma
- •Contraindications to exercise or diet interventions (e.g., co-morbid nutritional and metabolic diseases, physical injuries)
研究组 & 干预措施
NEW Tx
25 people will be randomized to NEW Tx, a weekly individualized psychotherapy. Therapy is 20 weeks long.
干预措施: Nutrition, Exercise, and Wellness (NEW) psychotherapy (Other)
Treatment as usual (TAU)
25 people will be randomized to TAU and will meet with their psychiatrist as often as clinically needed over the 20 week study duration.
干预措施: Typically consists of at least one FDA-approved mood stabilizer (Drug)
结局指标
主要结局
Client Satisfaction Questionnaire-8
时间窗: 20 weeks
Client Satisfaction Questionnaire-8 is a reliable and valid self-report of participants' acceptability of treatment. This is an assessment of client/patient satisfaction with their care and perceived quality and tolerability of NEW Tx. The scale for this item is a 4-point Likert scale ranging from 1 ("poor") to 4 ("excellent"). The score for each item is summed for a total score that ranges from 8 to 32 with higher scores indicating greater acceptability of the treatment.TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.
NEW Tx Scale
时间窗: 20 weeks
NEW Tx Scale is a 10-item scale to asses participants' expectations of NEW Tx their acceptability of NEW Tx at Week 20. This scale also includes a comments section to solicit unstructured feedback from participants on NEW Tx. The scale for this item is a 5-point Likert scale ranging from 1 ("strongly agree") to 5 ("strongly disagree"). The score for each item is summed for a total score that ranges from 10 to 50 with higher scores indicating poorer perception of the treatment. TAU participants only received this questionnaire if they chose to participate in the NEW Tx at week 20 of the intervention following the waitlist period.
次要结局
- Montgomery Asberg Depression Rating Scale(20 weeks)
- LIFE- Range of Impaired Functioning Tool(20 weeks)
- Young Mania Rating Scale(20 weeks)
- Body Mass Index (BMI)(20 weeks)
- Weekly Exercise Duration(20 weeks)
研究者
Louisa Grandin Sylvia
Instructor of Psychiatry
Massachusetts General Hospital