Bulimia NervosaPASNCT01470508
Engaging Latino Families in Eating Disorders Treatment
A study testing Cognitive Behavioral Therapy and Cognitive Behavioral Therapy with Family Enhancement in people with Bulimia Nervosa and Binge Eating Disorder, run by Mae Lynn Reyes-Rodriguez, PhD at 2 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Bulimia Nervosa, Binge Eating Disorder, Eating Disorder Not Otherwise Specified
- What is being tested?
- Cognitive Behavioral Therapy and Cognitive Behavioral Therapy with Family Enhancement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2010to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina
Chapel Hill, North Carolina, 27599-7160
UNC Center of Excellence for Eating Disorders
Chapel Hill, North Carolina, 27599
About this study
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.
Read the detailed description
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.
- Being tested
- Cognitive Behavioral Therapy, Cognitive Behavioral Therapy with Family Enhancement
- Keywords
- Bulimia, Binge-Eating Disorder, Eating Disorders
- Medical subject headings
- Bulimia Nervosa, Binge-Eating Disorder, Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
Also called Eating disorder treatment as usual
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.
Cognitive Behavioral Therapy with Family EnhancementBehavioural
Also called PAS
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.
| Study group | Role | What they receive |
|---|---|---|
| Family Enhancement | Experimental | PAS is a 27-week program consisting of 25 sessions, 50 minutes in length, between an individual and a therapist. During six (6) family sessions, a family member will accompany the individual to therapy and will take an active role during the session. In this program, individuals and their family members will learn about ways to communicate about their relationship in the context of experiencing an eating disorder. PAS focuses on family-specific skills such as communication skills and problem solving skills while also incorporating eating disorders psychoeducation. Receives: Behavioral: Cognitive Behavioral Therapy with Family Enhancement |
| Cognitive Behavioral Therapy | Active comparator | Individuals meet their therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. Receives: Behavioral: Cognitive Behavioral Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Measured: Baseline, End of Treatment
Secondary outcomes (18)
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment
Measured: Baseline, Week 6
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Measured: Baseline, End of Treatment
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up
Measured: Baseline, 3 Month Follow-up
Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment
Measured: Baseline, Week 6 of Treatment
Change from Baseline in Symptom Checklist-36 (SCL-36) score at End of Treatment
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Measured: Baseline, End of Treatment
Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up
Measured: Baseline, 3 Month Follow-up
Change from Baseline in Family Support Questionnaire score at End of Treatment
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Measured: Baseline, End of Treatment
Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up
Measured: Baseline, 3 Month Followup
Change from Baseline in Family Cohesion (FC) score at End of Treatment
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Measured: Baseline, End of Treatment
Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up
Measured: Baseline, 3 Month Follow-up
Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Measured: Baseline, End of Treatment
Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up
Measured: Baseline, 3 Month Follow-up
Change from Baseline in Family Score (FS) at End of Treatment
Measured: Baseline, End of Treatment
Change from Baseline in Family Score (FS) at 3 Month Follow-up
Measured: Baseline, 3 Month Follow-up
Treatment Adherence as of 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.
Measured: Baseline, End of Treatment
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment
Measured: Baseline, Week 6
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment
End of Treatment will be measured by the completion of the twenty-five (25) scheduled therapy session, regardless of treatment group.
Measured: Baseline, End of Treatment
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up
Measured: Baseline, 3 Month Follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2011 (estimated)
- Study startAug 2010
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mae Lynn Reyes-Rodriguez, PhD
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Institute of Mental Health (NIMH), El Futuro
- Responsible party
- Sponsor-investigator, Mae Lynn Reyes-Rodriguez, PhD, University of North Carolina, Chapel Hill
- Investigators
- Mae Lynn Reyes-Rodriguez, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01470508
- Sponsor's protocol ID
- 10-0773
- Other IDs
- IRB# 10-0773, K-23-MH087954-01A1
- Acronym
- PAS
- Status last verified
- May 2016
- First submitted
- 9 Nov 2011
- Last updated
- 18 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Engaging Latino Families in Eating Disorders Treatment
- ClinicalTrials.gov ID
- NCT01470508
- Acronym / sponsor ID
- PAS / 10-0773
- Keywords
- Bulimia, Binge-Eating Disorder, Eating Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Mae Lynn Reyes-Rodriguez, PhDUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill, National Institute of Mental Health (NIMH), El Futuro
- Study start
- Aug 2010
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 11 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Family Enhancement | Experimental | Behavioral: Cognitive Behavioral Therapy with Family EnhancementPAS is a 27-week program consisting of 25 sessions, 50 minutes in length, between an individual and a therapist. During six (6) family sessions, a family member will accompany the individual to therapy and will take an active role during the session. In this program, individuals and their family members will learn about ways to communicate about their relationship in the context of experiencing an eating disorder. PAS focuses on family-specific skills such as communication skills and problem solving skills while also incorporating eating disorders psychoeducation. |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Cognitive Behavioral TherapyIndividuals meet their therapist once a week for 25 sessions, 50 minutes in length, for a period of 27 weeks for therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyAlso: Eating disorder treatment as usualIndividuals 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. | Behavioural | Cognitive Behavioral Therapy |
| Cognitive Behavioral Therapy with Family EnhancementAlso: PASIndividuals 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. | Behavioural | Family Enhancement |
Primary outcome
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.
18 secondary outcomes
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at Week 6 of Treatment
Time frame: Baseline, Week 6
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at End of Treatment
Time frame: Baseline, End of Treatment
Change from Baseline in Beck Depression Inventory-Revised (BDI-R) score at 3 Month Follow-up
Time frame: Baseline, 3 Month Follow-up
Change from Baseline in the Symptom Checklist-36 (SCL-36) score at Week 6 of Treatment
Time frame: Baseline, Week 6 of Treatment
Change from Baseline in Symptom Checklist-36 (SCL-36) score at End of Treatment
Time frame: Baseline, End of Treatment
Change from Baseline in Symptom Checklist-36 (SCL-36) score at 3 Month Follow-up
Time frame: Baseline, 3 Month Follow-up
Change from Baseline in Family Support Questionnaire score at End of Treatment
Time frame: Baseline, End of Treatment
Change from Baseline in Family Support Questionnaire score at 3 Month Follow-up
Time frame: Baseline, 3 Month Followup
Change from Baseline in Family Cohesion (FC) score at End of Treatment
Time frame: Baseline, End of Treatment
Change from Baseline in Family Cohesion (FC) score at 3 Month Follow-up
Time frame: Baseline, 3 Month Follow-up
Change from Baseline in Family Burden Interview Scale (FBIS) score at End of Treatment
Time frame: Baseline, End of Treatment
Change from Baseline in Family Burden Interview Scale (FBIS) score at 3 Month Follow-up
Time frame: Baseline, 3 Month Follow-up
Change from Baseline in Family Score (FS) at End of Treatment
Time frame: Baseline, End of Treatment
Change from Baseline in Family Score (FS) at 3 Month Follow-up
Time frame: Baseline, 3 Month Follow-up
Treatment Adherence as of End of Treatment
Time frame: Baseline, End of Treatment
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at Week 6 of Treatment
Time frame: Baseline, Week 6
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at End of Treatment
Time frame: Baseline, End of Treatment
Change from Baseline in Eating Disorder Examination Questionnaire (EDE-Q) score at 3 Month Follow-up
Time frame: Baseline, 3 Month Follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mae Lynn Reyes-Rodriguez, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy and Cognitive Behavioral Therapy with Family Enhancement in people with Bulimia Nervosa and Binge Eating Disorder, run by Mae Lynn Reyes-Rodriguez, PhD at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Eating Disorder Examination (EDE) Scores at End of Treatment (time frame: Baseline, End of Treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2016.