Internet-based relapse prevention for in-patients with anorexia nervosa

Not Applicable

Completed

Conditions: Severe anorexia nervosa (AN)
Mental and Behavioural Disorders
Eating disorders

Registration Number: ISRCTN18274621

Lead Sponsor: South London and Maudsley NHS Foundation Trust (UK)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 98

Inclusion Criteria

1. Patients fulfilling criteria for the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) AN or atypical AN who have undergone a period of in-patient treatment in one of the participating Eating Disorders Services
2. Both males and females, aged 13 years or over
3. Patients who have reliable access to broadband internet
4. Available over the full duration of the study
5. Patients who have shown clinically significant weight gain during in-patient treatment (a minimum of approximately 6 kg or 2 body mass index [BMI] points)

Exclusion Criteria

1. Unstable AN i.e. actively losing weight at the end of treatment
2. Insufficient knowledge of English or literacy levels insufficient to allow understanding of the manual and assessment
3. Psychosis
4. Acute suicidality
5. Substance dependence
6. Diabetes mellitus

Informed written consent will be sought from patients and for adolescents from their parents at initial assessment.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Proportion of people who relapse, assessed at 6 and 12 months <br>2. Time to relapse, assessed at 6 and 12 months <br>3. Body mass index, measured monthly for 12 months <br>4. Global Eating Disorders Examination (EDE) scores at end of treatment (6 months) and follow-up (12 months) <br><br>Relapse will be defined as follows: Weight loss of >2 BMI points (or 6 kg) for 2 consecutive weeks or in-patient treatment due to weight loss or severe medical complications other than low weight resulting from the AN and requiring in-patient treatment (e.g., severe hypokalaemia) or severe psychiatric disorder (e.g., suicidality) requiring in-patient treatment.

Secondary Outcome Measures

Name	Time	Method
1. Interview measures, carried out at baseline, 6 and 12 months: <br>1.1. EDE <br>1.2. Client Services Receipt Interview (CSRI) <br>2. Questionnaire measures for the assessment of anxiety-related processes, carried out at baseline, 1, 6 and 12 months: <br>2.1. Intolerance of uncertainty scale <br>2.2. Penn State Worry Questionnaire <br>2.3. Cognitive avoidance questionnaire (CAQ) <br>2.4. Meta-Cognitions Questionnaire (MCQ-30) <br>2.5. Negative problem orientation questionnaire (NPOQ) <br>3. Questionnaire measures for the assessment of other psychopathology, carried out at baseline, 1, 6 and 12 months: <br>3.1. Depression, Anxiety and Stress Scale (DASS) - Short Version (21 items) <br>3.2. World Health Organization Quality of Life ? brief <br>4. Biological measure: Salivary cortisol, measured at baseline, 1, 6 and 12 months