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Completed

NCT Number: NCT01470508

Engaging Latino Families in Eating Disorders Treatment

Promoviendo Alimentacion Saludable (PAS)"Promoting Healthy Eating" is a research project funded by the National Institute of Mental Health. The purpose of this study is to develop and test a treatment for eating disorders in Latina adults that is appropriate for their age and includes culturally appropriate family intervention.

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Key information

Conditions

Bulimia Nervosa Binge Eating Disorder Binge-Eating Disorder Bulimia Eating Disorder Not Otherwise Specified Feeding and Eating Disorders Hyperphagia Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UNC Center of Excellence for Eating Disorders, Chapel Hill, North Carolina, United States

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About this study

Research on culturally sensitive assessment and treatment of eating disorders among Latinos is scarce. This study is comparing individual Cognitive Behavioral Therapy (CBT) versus CBT with a family adjunctive intervention for eating disorders in Latina adults. All treatment will be conducted by trained professionals from either the UNC Eating Disorders Program (in Chapel Hill) or from El Futuro, Inc. (in Carrboro or Durham, NC) who have been trained in the treatment of eating disorders.

Participants will participate in 25, 50 minute-long, face-to-face CBT sessions over 27 weeks. Participants will be randomly placed in one of two groups: CBT or CBT with family enhancement. Those participants who are randomly placed into the CBT group will participate in 25 individual therapy sessions, 3 sessions with a dietitian, and psychiatry and/or medical assessments as needed. Those participants who have been randomly placed into the CBT with family enhancement group will participate in 19 individual therapy sessions, 6 family therapy sessions, 3 sessions with a dietitian, and psychiatry and/or medical assessments as needed. All participants will also be expected to participate in baseline, week 6 (mid-treatment), end of treatment, and 3-month follow-up assessments.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • DSM-IV criteria for BN, BED, EDNOS (sub-threshold BN)
  • Latina
  • If taking antidepressant medication, stable dose for at least 3 months prior
  • Willingness to ask a family member or significant other to participate AND agreement of family member to participate

Exclusion criteria

  • Any major medical condition that would interfere with treatment or require alternative treatment
  • Alcohol or drug dependence in the last three months
  • Current significant suicidal ideation
  • Developmental disability that would impair the ability of the participant to benefit from psychotherapy effectively
  • Psychosis, including schizophrenia, or bipolar I disorder
  • Pregnancy
  • Body mass index below 17.5 kg/m^2
  • If taking antidepressant medication, doses are not stable; individuals taking any medications that can significantly affect appetite or weight.

Treatment and study plan

Cognitive behavioral therapy

Behavioral

Individuals meet with a therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. Cognitive Behavioral Therapy is manualized and is the standard form of care at the UNC Eating Disorders Program.

Other names: Eating disorder treatment as usual

Cognitive Behavioral Therapy with Family Enhancement

Behavioral

Individuals will meet with a therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. Cognitive Behavioral Therapy with Family Enhancement is manualized and will involve the participation of family members during six (6) weeks of treatment.

Other names: PAS

Primary outcomes

  1. Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment

    Time frame: Baseline, End of Treatment

    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

Secondary outcomes

  1. Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment

    Time frame: Baseline, Week 6

  2. Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment

    Time frame: Baseline, End of Treatment

    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  3. Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up

    Time frame: Baseline, 3 Month Follow-up

  4. Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment

    Time frame: Baseline, Week 6 of Treatment

  5. Change from Baseline in Symptom Checklist-36 (SCL-36) score at End of Treatment

    Time frame: Baseline, End of Treatment

    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  6. Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up

    Time frame: Baseline, 3 Month Follow-up

  7. Change from Baseline in Family Support Questionnaire score at End of Treatment

    Time frame: Baseline, End of Treatment

    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  8. Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up

    Time frame: Baseline, 3 Month Followup

  9. Change from Baseline in Family Cohesion (FC) score at End of Treatment

    Time frame: Baseline, End of Treatment

    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  10. Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up

    Time frame: Baseline, 3 Month Follow-up

  11. Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment

    Time frame: Baseline, End of Treatment

    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  12. Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up

    Time frame: Baseline, 3 Month Follow-up

  13. Change from Baseline in Family Score (FS) at End of Treatment

    Time frame: Baseline, End of Treatment

  14. Change from Baseline in Family Score (FS) at 3 Month Follow-up

    Time frame: Baseline, 3 Month Follow-up

  15. Treatment Adherence as of End of Treatment

    Time frame: Baseline, End of Treatment

    Treatment Adherence will be measured positively if a participant has completed at least 80% of treatment (20 sessions or more) or negatively if less than 80% of treatment (19 sessions or less) has been completed.

  16. Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment

    Time frame: Baseline, Week 6

  17. Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment

    Time frame: Baseline, End of Treatment

    End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.

  18. Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up

    Time frame: Baseline, 3 Month Follow-up

Other outcomes

  1. M-FED Questionnaire

    Time frame: 3 Month Follow-up

Sponsors and collaborators

Lead sponsor

Mae Lynn Reyes-Rodriguez, PhD

Other

Collaborators

  • El Futuro
  • National Institute of Mental Health (NIMH)
  • University of North Carolina, Chapel Hill

Registry information

Acronym: PAS

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Nov 11, 2011
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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