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Efficacy and acceptability of a new emotional and social mind group training programme for bulimia nervosa
ISRCTN ISRCTN61115988
DOI 10.1186/ISRCTN61115988
ClinicalTrials.gov identifier
EudraCT number
Public title Efficacy and acceptability of a new emotional and social mind group training programme for bulimia nervosa
Scientific title A preliminary randomised controlled trial of the efficacy and acceptability of a new emotional and social mind group training programme versus standard cognitive behavioural group therapy for bulimia nervosa
Acronym N/A
Serial number at source N/A
Study hypothesis A 17-session group based intervention emotional and social mind training (ESM) targeting the key maintenance variables for bulimia nervosa outlined above will be superior to a 17-session group-based standard cognitive behavioural therapy (CBT) programme for this group, in terms of achieving symptomatic improvement in bulimic symptoms and mood.

Subsidiary hypotheses:
1. Drop out will be lower in the ESM than the CBT group
2. Acceptability of treatment will be superior in the ESM group, compared with the CBT programme
3. ESM will be superior to the CBT programme in terms of the following variables, which will mediate or moderate symptom change:
3.1. Reducing intolerance of emotional distress (moderator)
3.2. Decreasing negative self-evaluation (mediator)
3.3. Increasing adaptive emotional expression and processing (mediator)
3.4. Increasing ability to regulate negative mood (mediator)
3.5. Reducing self-criticism (mediator)
3.6. Reducing negative beliefs about emotions (mediator)
3.7. Reducing rumination (mediator)
3.8. Reducing socially submissive behaviour (mediator)
3.9. Improving social cognition (mediator)
Lay summary Lay summary under review 2
Ethics approval The Joint South London and Maudsley and Institute of Psychiatry NHS Research Ethics Committee approved in November 2008 (ref: 08/H0807/83)
Study design Single centre, two-arm single-blind randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Bulimia nervosa (BN)/eating disorder not otherwise specified (EDNOS)
Participants - inclusion criteria 1. Patients referred to the South London and Maudsley Eating Disorder Service who fully (bulimia nervosa [BN]) or partially (eating disorder not otherwise specified [EDNOS]) fulfil Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria for bulimia nervosa
2. Outpatients
3. Male or female
4. Aged 18 - 65 years
Participants - exclusion criteria 1. Insufficient knowledge of English or literacy levels to allow understanding of the intervention materials
2. Active suicidality
3. Severe substance dependence
4. Diabetes
5. Pregnancy
6. Received Maudsley Model treatment for eating disorder within last 12 months
Anticipated start date 20/04/2009
Anticipated end date 20/10/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 76
Interventions Group 1: Emotional and social mind training (ESM) -
Patients in this group will receive a 17-session treatment (4 individual sessions, 12 group sessions, 1 follow-up session). The individual sessions will be used to develop an individual case formulation. The 12 group sessions will address:
1. Identification and understanding of inter- and intra-personal emotions
2. The social context of emotions
3. Managing intense and overwhelming emotions
4. Managing shame through compassionate mind training

The follow-up session will be a 'booster' for the group. Sessions will take place on a weekly basis. Individual sessions will be 60 and group sessions 90 minutes in length. Group sessions will include eight patients and be facilitated by two therapists. Overall, treatment will last 3 - 4 months.

Group 2: Group CBT programme -
Patients in this group will receive a 17-session group-based cognitive behavioural therapy treatment (4 individual sessions, 12 group sessions, 1 follow-up session). As with the ESM group, the individual sessions will be used to develop an individual case formulation. The timescales and group makeup will be identical to those of the ESM group.

Research assessments will take place at baseline, 4 months (end of treatment) and 6 months (follow-up). Severity of core bulimic symptoms (bingeing, purging, etc.) will be assessed using the Eating Disorders Examination. The following questionnaires/tests will also be used:
1. Depression Anxiety Stress Scale (DASS-21)
2. Levels of Self-Criticism Scale (LOSC)
3. Distress Tolerance Scale (DTS)
4. Beliefs About Emotions Questionnaire
5. Submissive Behaviour Scale (SBS)
6. Rumination Subscale of the Response Style Questionnaire (RSQ)
7. Clinical Impairment Assessment Questionnaire (CIA)
8. Participant satisfaction, assessed using Visual Analogue Scales

Social cognition tasks:
9. Reading the Mind from the Eyes Test
10. Reading the Mind in Films Task
11. Interpersonal Perception Task-15 (IPT-15)

Neuropsychological tests:
12. The National Adult Reading Test (NART)
13. D2 Brickenkamp Letter Cancellation Task (d2)
14. Rewarded Continuous Performance Task
15. Go/No-go task
16. Stroop colour word task
17. Game of dice task
Primary outcome measure(s) Core bulimic symptomology (bingeing, purging, etc.) measured by the Eating Disorders Examination (EDE) at baseline (pre-treatment), 4 months (end of treatment) and 6 months (follow-up).
Secondary outcome measure(s) 1. Symptoms of depression, anxiety and stress, respectively, measured by the Depression Anxiety and Stress Scales (DASS-21). 21 items, each scored 0 - 3, giving total score of 0 - 63. Comprised of 3 scales (7 items each) for depression, anxiety and stress scoring 0 - 21, respectively. For each item score represents 0 (no symptom at all), 1 (symptom present to some degree, or some of the time), 2 (symptom present to considerable degree, or good part of the time), 3 (symptom present very much, or most of the time). Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
2. Negative self-evaluation (comparative self-criticism and internalised self-criticism) measured by the Levels of Self-Criticism Scale (LOSC). 22 items, each scored 1 - 7 (strongly disagree to strongly agree), giving a total score of 22 - 154. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
3. Means of coping with negative mood and regulating emotional state measured by the Distress Tolerance Scale (DTS). 20 items, each scored 1 - 5 (never to all the time), giving a total score of 20 - 100. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
4. Beliefs about expressing emotions, coping with emotions and validity of emotions measured by the Beliefs About Emotions Questionnaire. 12 items, for each score 1 - 7 (totally agree to totally disagree). Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
5. Submissive behaviour measured by the Submissive Behaviour Scale (SBS). 16 items, measured on scale 0 - 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = mostly, 4 = always), giving total score 0 - 64. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
6. Ruminative Response Style Scale of the response Styles Questionnaire (RSQ). 22 items, measured on scale 0 - 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = mostly, 4 = always), giving total score 0 - 88. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
7. Clinical Impairment Assessment Questionnaire (CIA), a 16-item self-report measure of the severity of psychosocial impairment due to eating disorder features. Each item scored 0 - 3, with a higher rating indicating a higher level of impairment. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
8. Participant satisfaction will be measured using visual analogue scales
9. Social cognition measured by Reading the Mind from the Eyes Test. 36 items, score 0 - 36. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
10. A more complex form of social cognition measured by the 'Reading the Mind in the Films task' (RMF). 22 items, score 0 - 22. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
11. Social perception measured by the Interpersonal Perception Task-15 (IPT-15). 15 items, score 0 - 15. Completed at pre-treatment only.
12. Premorbid levels of intelligence as estimated by the National Adult Reading Test (NART). Completed at pre-treatment only.
13. Selective attention/concentration measured by the D2 Brickenkamp Letter Cancellation Task (d2). Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
14. Sustained attention and the effect of reward upon it, measured by the Rewarded Continuous Performance Task. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
15. Motor response inhibition measured by the Go/NoGo task. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
16. Concentration and speed of information processing measured by the Stroop colour word task. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
17. Decision-making measured by the Game of dice task. Completed at pre-treatment, end of treatment (4 months) and follow-up (6 months).
Sources of funding Swiss Anorexia Nervosa Foundation (Switzerland)
Trial website http://www.eatingresearch.com
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/23118850
Contact name Prof  Ulrike  Schmidt
  Address Section of Eating Disorders
Box 059
Institute of Psychiatry
De Crespigny Park
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Tel +44 (0)20 7848 0181
  Fax +44 (0)20 7848 0182
  Email u.schmidt@iop.kcl.ac.uk
Sponsor Institute of Psychiatry (UK)
  Address c/o Ms Gill Lambert
Research Governance/Clinical Trials Facilitator
PO05, R&D Office
De Crespigny Park
  City/town London
  Zip/Postcode SE5 8AF
  Country United Kingdom
  Sponsor website: http://iop.kcl.ac.uk
Date applied 14/04/2009
Last edited 05/02/2013
Date ISRCTN assigned 29/05/2009
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