Feedback Versus no Feedback to Improve Patient Outcome in Group Psychotherapy for Eating Disorders: A Randomised Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 159
- 试验地点
- 2
- 主要终点
- Adherence
研究概览
简要总结
The current trial aims to investigate the impact of continuous feedback on dropout and outcome in group therapy. The hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1) increase adherence and 2) increase treatment outcome.
详细描述
Background: In the psychotherapy of eating disorders, a dropout rate between 30% and 50% is reported internationally. The fact that up to half of the patients drop out of treatment calls for ways to improve it. Research shows that feedback to patient and therapist increases outcome and reduces the number of dropouts; however there is only three published works on the effect of feedback in eating disorders treatment. Therefore, the present trial, at the eating disorders unit at Stolpegaard Psychotherapy Centre, Gentofte, Denmark, may contribute to necessary improvements in the field.
Objective
The current trial, which will be conducted from August 2012 to August 2014, aims to investigate the impact of continuous feedback on adherence and outcome in group psychotherapy. The hypothesis is that continuous feedback to patient and therapist on treatment progress and alliance will 1)increase adherence 2) increase treatment outcome.
Method: The trial is set up in a randomized design with 159 patients allocated to a) treatment with feedback intervention or b) treatment as usual.
Participants: The participants are diagnosed with Bulimia Nervosa, Binge Eating Disorder or Eating Disorder Not Otherwise Specified.
Interventions: In the experimental group, two sets of feedback measures are added to the standard treatment: Outcome Rating Scale (ORS) and Group Session Rating Scale (GSRS). The ORS assesses areas of life functioning known to change as a result of therapeutic intervention. The GSRS assesses key dimensions of effective therapeutic relationships.
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
- Double (Investigator, 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
- 否
入选标准
- •Aged 18 or older.
- •BMI of minimum
- •Meet the diagnostic criteria for Bulimia Nervosa, Binge Eating Disorder or EDNOS according to DSM- IV.
排除标准
- •Acute suicidal risk.
- •Psychosis.
- •Severe depression.
- •Abuse of alcohol, medicine and/or narcotics up to 3 months before referral.
- •Use of cannabis once a month is accepted at intake but must stop during treatment.
- •Concomitant psychotherapeutic/ psychiatric treatment outside Stolpegaard Psychotherapy Centre.
- •Severe or non-regulated physical co-morbidity.
- •Pregnancy.
- •Unable to understand Danish.
- •Previous participation in the current trial.
- •Considered unable to attend treatment sessions as planned.
- •Lack of informed consent.
结局指标
主要结局
Adherence
时间窗: At end of treatment. Participants will be followed for the duration of treatment, an expected average of 20 weeks.
Treatment adherence in the intervention period defined as a rate, i.e., number of attended therapy sessions divided by the number of planned therapy sessions. If a patient ends therapy prematurely, and this is in accordance with the therapists, the number of attended sessions will be set equal to the planned number of sessions.
次要结局
- Eating Disorders Examination Interview(At intake, end of treatment and follow-up. Participants will be followed for the duration of treatment and follow-up, an expected average of 3 years.)
研究者
Marianne Lau, MD, DSci.
Research Manager
Psychotherapeutic Center Stolpegard