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临床试验/NCT04064255
NCT04064255已完成不适用

A Pilot Study Evaluating Practical Body Image (PBI): A Body Image Therapy With Mirror Exposure for Adolescent Inpatients With Anorexia Nervosa

Newbridge House0 个研究点目标入组 40 人开始时间: 2016年9月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
主要终点
Body Image Acceptance and Action Questionnaire

研究概览

简要总结

Background:

Dysfunctional body image is a strong predictor of maintenance and relapse in anorexia nervosa, making treatment of such clinically and financially important. Studies have shown that cognitive behavioural based group therapies and mirror exposure interventions are effective in improving body image in adults with eating disorders; however research into individual body image treatments for adolescents with anorexia nervosa is limited.

Practical Body Image (PBI) is a novel, manualised, individual treatment designed for adolescents with anorexia nervosa for which the evidence base is not yet established. This research will therefore contribute to the evidence base for the treatment of body image in adolescents with anorexia nervosa and inform the effectiveness of a new treatment. The research will be funded by Newbridge House, an inpatient unit for children and adolescents with eating disorders.

Research Questions:

Does Practical Body Image improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa?

Does a mirror exposure intervention improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of the programme?

Design:

Patients aged 11-18, fulfilling DSM-V criteria for anorexia nervosa and receiving treatment at Newbridge House will be recruited for participation in the research study. Participants will be randomly allocated to either a case or control group. Allocation will be based on a non-blind randomised controlled trial. Cases will receive PBI in addition to treatment as usual and will be compared with controls who just receive treatment as usual. Both groups will complete a set of questionnaires at baseline, 7 weeks and 10 weeks.

详细描述

PRINCIPAL NULL HYPOTHESIS PBI will have no impact on body image or psychological wellbeing in adolescent inpatients with anorexia nervosa compared to just TAU.

SECONDARY NULL HYPOTHESIS Mirror exposure will have no effect on body image or psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of PBI.

PRINCIPAL ALTERNATIVE HYPOTHESIS PBI will improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa compared to just TAU.

SECONDARY ALTERNATIVE HYPOTHESIS Mirror exposure will improve body image and psychological wellbeing in adolescent inpatients with anorexia nervosa after completion of the rest of PBI.

The alternative hypotheses were chosen based previous research which shows that cognitive behavioural techniques and mirror exposure are effective in improving body image disturbance and psychological wellbeing in adults with anorexia nervosa. This study aims to generate hypotheses about which specific elements of body image (i.e. body avoidance, body acceptance, body anxiety or weight and shape concern) and psychological wellbeing (i.e. self esteem, anxiety and depression) change after completion of PBI.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
None

入排标准

年龄范围
11 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Inpatients at Newbridge House
  • At or above 90% of minimum healthy weight
  • Primary diagnosis of Anorexia Nervosa

排除标准

  • Previously received treatment at Newbridge House (readmission)
  • Patients with a primary diagnosis other than Anorexia Nervosa
  • Aged under 11 years
  • Any patients with severe learning difficulty
  • Active psychosis

研究组 & 干预措施

Case: Practical Body Image + Treatment as Usual

Active Comparator

The Case arm involves Practical Body Image + treatment as usual.

Practical Body Image is based on a cognitive behavioural model of body image addressing thoughts, feelings, behaviours and misperceptions. PBI is designed to be administered over 10 weeks (6 weekly sessions over 6 weeks, followed by 8 twice weekly sessions over 4 weeks).

Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.

干预措施: Practical Body Image (session 1 - 7) (Other)

Case: Practical Body Image + Treatment as Usual

Active Comparator

The Case arm involves Practical Body Image + treatment as usual.

Practical Body Image is based on a cognitive behavioural model of body image addressing thoughts, feelings, behaviours and misperceptions. PBI is designed to be administered over 10 weeks (6 weekly sessions over 6 weeks, followed by 8 twice weekly sessions over 4 weeks).

Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.

干预措施: Practical Body Image (session 8 - 14) (Other)

Control: Treatment as Usual Only

No Intervention

Control arm involves treatment as usual only.

Treatment as usual refers to the standard inpatient treatment programme at Newbridge House which includes: individual therapy, occupational therapy, drama therapy, family therapy, dietetic support, nursing support, yoga and medication prescribed by a consultant psychiatrist.

结局指标

主要结局

Body Image Acceptance and Action Questionnaire

时间窗: Assessed at baseline, 7 weeks and 10 weeks.

A validated self-report measure assessing change in cognitive flexibility and acceptance relatively to body image. The measure consists of 12 questions.

次要结局

  • Youth Eating Disorder Examination Questionnaire(Assessed at baseline, 7 weeks and 10 weeks.)
  • Body Image Avoidance Questionnaire(Assessed at baseline, 7 weeks and 10 weeks.)
  • Healthy weight body acceptance scale(Assessed at baseline, 7 weeks and 10 weeks.)
  • Physical Appearance State and Trait Anxiety Scale: Trait Version(Assessed at baseline, 7 weeks and 10 weeks.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

John Morgan

Consultant Psychiatrist

Leeds and York Partnership NHS Foundation Trust

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