Individual Schema-mode Therapy for Anorexia Nervosa: a Pilot Case Series

NCT02666495 | Completed

• 1 other identifier: 2015/0228
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

A reliably effective treatment model for anorexia nervosa is yet to emerge. Recent clinical trials of psychological therapies over 20-30 sessions, have shown modest benefits. There is therefore a need to test new treatments to find more effective treatments. Clinical trials of Schema Therapy have shown low rates of dropout, which is often a problem in the treatment of anorexia nervosa. Treatment with Schema Therapy, for significantly longer than 20-30 sessions, has been shown to be effective for other complex mental health problems.This pilot study is therefore designed to pilot the use of individual Schema Therapy for people with Anorexia Nervosa (iST-AN). This study is a case series pilot study. The study will answer the principal research question: Does individual Schema mode Therapy, adapted for eating disorders, have the potential to improve symptoms, quality of life and weight in people with moderate-severe anorexia nervosa? It will also address secondary research questions: Can people with moderate-severe anorexia nervosa be recruited to, and kept engaged in, a study of iST-AN treatment? What is the ideal length of iST-AN treatment? What is the relationship between self-criticism, body shame, or unhelpful psychological 'modes' and clinical outcome? Fifteen people with moderate-severe Anorexia Nervosa will be recruited from referrals to a specialist eating disorders outpatient service. The study will deliver 65 sessions of Schema Therapy for anorexia nervosa (iST-AN), over a 24 month period, alongside any additional medical or dietetic management required. Standard outcome measures will be collected at 6 month intervals. The research team have expertise in eating disorders research, schema therapy for severe anorexia nervosa and are all members of the local clinical service. The study will take place over a 3 year period.

Conditions

Anorexia Nervosa

Keywords

Schema Therapy

Outcome Measures

Primary Outcomes (1)

• Eating Disorders Examination questionnaire (EDE-Q)

  A validated self-report measure of eating disorder symtpoms.

  6 monthly

Secondary Outcomes (4)

• Body Mass INdex (BMI)

  6 monthly

• WHO-QoL (bref)

  6 monthly

• Symptom Check List - 90

  6 monthly

• Global Assessment of Functioning (GAF)

  6 monthly

Other Outcomes (3)

• Forms of Self-Criticism/Self-Reassuring scale (FSCRS)

  6 monthy

• Body shame items of the Experiences of Shame Scale (ESS)

  6 monthly

• Schema Mode Inventory (SMI)

  baseline and 24 months

Interventions

Psychological Therapy - Schema Therapy OTHER

Psychological treatment using individual Schema-Mode Therapy for Anorexia Nervosa (iST-AN). A 60 session protocol will be used over an 18 month period, moving flexibly through five phases of treatment, guided by the psychological formulation: phase 1 - assessment, engagement \& stabilisation; phase 2 - developing trust \& understanding; phase 3 - developing awareness \& acceptance; phase 4 - testing change \& strengthening the healthy mode; phase 5 - consolidating change. A follow-up period of 6 months, with 5 further monthly sessions, will promote self-efficacy and further consolidate change. A total treatment package of 65 sessions will be offered, over 24 months.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of AN or other DSM-V underweight eating disorder diagnosis AND
• yrs or over AND
• Moderate-severe, treatment resistant, comorbid, or chronic 3.1. BMI 13-15 OR 3.2. BMI 15-17.5 and ≥ 1 previous treatment episode for eating disorder OR 3.3. BMI 15-17.5 and a personality disorder diagnosis OR 3.4. BMI 15-17.5 and duration of eating disorder of \> 10 yrs

You may not qualify if:

• Diagnosis of psychotic disorder
• Diagnosis of alcohol or drug dependence
• Diagnosis of learning disability or autistic spectrum disorder
• English language skills not adequate for therapy
• Previous treatment with Schema Mode Therapy
• Unable to make realistic commitment to attend weekly appointments

Sponsors & Collaborators

• NHS Lothian: lead

Study Sites (1)

Royal Edinburgh Hospital

Edinburgh, EH10 5HF, United Kingdom

Location

MeSH Terms

Conditions

Anorexia Nervosa

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: January 28, 2016
• Study Start: January 25, 2015
• Primary Completion: August 31, 2018
• Study Completion: August 31, 2018
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

GB (1)