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

NCT02666495 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2024-09-23

No results posted yet for this study

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

Interventions

OTHER

Psychological Therapy - Schema Therapy

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.

Sponsors & Collaborators

  • NHS Lothian

    lead OTHER_GOV

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-01-25
Primary Completion
2018-08-31
Completion
2018-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02666495 on ClinicalTrials.gov