- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07579442
Incorporating Narrative Into the Treatment of Youth With Anorexia Nervosa (Virtual)
Incorporating Narrative Into the Treatment of Youth With Anorexia Nervosa
The goal of this clinical trial is to evaluate whether a narrative medicine (NM) curriculum can enhance self-expression, reflection, and resilience in adolescents and young adults with anorexia nervosa.
The main questions it aims to answer are:
- Does participation in an NM curriculum improve self-expression and reflection in individuals with anorexia nervosa?
- Does engaging in creative writing and group discussion promote resilience and emotional processing in this population?
Participants will be 16-25 years old, medically stable for outpatient eating disorder therapy, and actively engaged in treatment. Those with active suicidal ideation, recent non-suicidal self-injury, or a co-occurring personality disorder will not be eligible.
Participants will:
- Attend six weekly workshops focused on themes such as self-definition, kindness, resilience, and possibility
- Engage in close reading of visual or written texts
- Complete creative writing exercises in response to prompts
- Participate in group discussions and sharing
An optional capstone reading event will provide a supportive space for participants to share their work with peers, loved ones, and providers, fostering connection and community.
This study aims to explore the role of narrative medicine in eating disorder treatment and assess its potential benefits for psychological well-being and self-expression.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Anoushka A Sinha, MD, MS
- Phone Number: 628-286-6116
- Email: anoushka.sinha@ucsf.edu
Study Locations
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California
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San Francisco, California, United States, 94158
- Recruiting
- UCSF Nancy Friend Pritzker Psychiatry Building
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Contact:
- Sara Buckelew, MD, MPH
- Phone Number: 415-502-1649
- Email: sara.buckelew@ucsf.edu
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 16-25 years old
- have a DSM-5 diagnosis of AN (confirmed by the UCSF Eating Disorders Program clinical team),
- currently engaged in outpatient eating disorder treatment, ensuring medical stability and capacity for a group-based intervention
- English fluency to engage in reflective writing and discussions
- Cognitive ability to meaningfully participate in narrative-based exercises
Exclusion Criteria:
- Currently medically unstable or require inpatient hospitalization
- History of psychosis, schizophrenia spectrum disorder, bipolar disorder, or personality disorder
- Severe neurocognitive impairment that would prevent engagement with the intervention
- Active suicidal ideation or non-suicidal self-injury within the past two months
- Insufficient English proficiency to participate in group discussions and writing exercises
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Narrative Medicine (NM) Workshop Series
Participants in this study will take part in a six-week Narrative Medicine (NM) curriculum designed to enhance self-expression, reflection, and resilience in individuals with anorexia nervosa. Workshops will be conducted weekly on Zoom and will include:
|
The Narrative Medicine (NM) Workshop Series is a structured six-week behavioral intervention designed to enhance self-expression, reflection, and resilience in adolescents and young adults recovering from eating disorders. This intervention differs from traditional psychotherapeutic or psychoeducational approaches by integrating literary analysis, creative writing, and guided discussion as therapeutic tools. Each one-hour weekly workshop includes:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of participants in each session
Time Frame: Immediately post-intervention (Week 6)
|
Feasibility will be measured by participant retention in intervention.
|
Immediately post-intervention (Week 6)
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Satisfaction with intervention components using 5-point Likert scales and semi-structured individual interviews
Time Frame: Immediately post-intervention (Week 6)
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Acceptability will be measured by questionnaire including 5-point Likert scales and semi-structured individual interviews assessing content relevance, writing prompts, group discussions, and facilitation. Scale title: Intervention Satisfaction Questionnaire (ISQ) Minimum value: 1 (Strongly Disagree) Maximum value: 5 (Strongly Agree) Interpretation: Higher scores indicate greater satisfaction with the intervention (better outcome). |
Immediately post-intervention (Week 6)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Social Connectedness
Time Frame: Pre- (Week 0) and immediately post-intervention (Week 6)
|
Measured using the Social Connectedness Scale (SCS), which assesses perceived closeness to others and sense of belonging. Scale title: Social Connectedness Scale (SCS) Minimum value: 1 (Strongly Disagree) Maximum value: 6 (Strongly Agree) Interpretation: Higher scores indicate greater feelings of social connectedness and belonging (better outcome). |
Pre- (Week 0) and immediately post-intervention (Week 6)
|
|
Depression Symptoms
Time Frame: Pre- (Week 0) and immediately post-intervention (Week 6)
|
Measured using the Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms. Scale title: Patient Health Questionnaire-9 (PHQ-9) Minimum value: 0 (Not at all) Maximum value: 3 (Nearly every day) Interpretation: Higher scores indicate greater severity of depressive symptoms (worse outcome). |
Pre- (Week 0) and immediately post-intervention (Week 6)
|
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Anxiety Symptoms
Time Frame: Pre- (Week 0) and immediately post-intervention (Week 6)
|
Measured using the Generalized Anxiety Disorder-7 (GAD-7) for anxiety. Scale title: Generalized Anxiety Disorder 7-item (GAD-7) Scale Minimum value: 0 (Not at all) Maximum value: 3 (Nearly every day) Interpretation: Higher scores indicate greater severity of anxiety symptoms (worse outcome). |
Pre- (Week 0) and immediately post-intervention (Week 6)
|
|
Eating Disorder Severity
Time Frame: Pre- (Week 0) and immediately post-intervention (Week 6)
|
Measured using the Eating Disorder Examination Questionnaire (EDE-Q), which captures cognitive and behavioral symptoms of AN, and percent of expected body weight (EBW) at follow-up. Scale title: Eating Disorder Examination Questionnaire (EDE-Q) Minimum value: 0 (No days / Not at all) Maximum value: 6 (Every day / Extremely) Interpretation: Higher scores indicate greater severity of eating disorder psychopathology (worse outcome). |
Pre- (Week 0) and immediately post-intervention (Week 6)
|
|
Illness-Identity Centrality
Time Frame: Pre- (Week 0) and immediately post-intervention (Week 6)
|
Assessed using the Illness Identity Questionnaire, which evaluates self-concept clarity and personal identity coherence. Scale title: Illness Identity Questionnaire (IIQ) Minimum value: 1 (Strongly Disagree) Maximum value: 5 (Strongly Agree) Interpretation: Subscale scores reflect distinct illness identity states; higher scores indicate greater endorsement of that identity orientation |
Pre- (Week 0) and immediately post-intervention (Week 6)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Anoushka Sinha, MD, MS, University of California, San Francisco
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 24-43017 (b)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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