Eating DisorderICAT-ANCT03324724
Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders
A study testing Integrative cognitive-affective therapy for adolescents (ICAT-A) in people with Eating Disorder and Emotional Disorder, run by Mayo Clinic at 1 site in United States.
Trial summary
Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has shown promise in reducing eating disorder symptoms as well as improving emotion regulation capacities in adults. Read more about this study
- Who is it for?
- Ages 14 to 20 years
- Conditions the study is for
- Eating Disorder, Emotional Disorder
- What is being tested?
- Integrative cognitive-affective therapy for adolescents (ICAT-A)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jan 2017to Oct 2021
- 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 14 to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Subject with full and sub-threshold bulimia nervosa and binge eating disorder (that is binge eating weekly)
- No major weight loss (defined as a reduction of 10% baseline body weight or more)
- Subject who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) eating disorder characterized by binge eating with or without compensatory behavior
- Subjects who take medications that do not directly impact weight or appetite (including Selective serotonin reuptake inhibitors (SSRI) antidepressants) will be included if their dose has been stable for at least six weeks
- Subject must be living at home
- At least one parent/guardian is willing to participate in the treatment.
Who cannot join
- Subject on medications that influence weight or appetite (including antipsychotic medications)
- Subject who is medically or psychiatrically unstable (defined as requiring hospitalization within the past 3 months)
- Acutely suicidal requiring current hospitalization or who meet criteria for substance use disorder in the past month
- Subjects who become or psychiatrically unstable during the study will be re-evaluated, removed from the study, and referred for appropriate treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders (ICAT-A)
Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has shown promise in reducing eating disorder symptoms as well as improving emotion regulation capacities in adults. However, this treatment has not been investigated in an adolescent sample. Given the contributing role of emotion regulation in adolescent eating disorder symptoms and limited treatment options for adolescents with BN and BED, the aim of this study is to adapt the existing adult ICAT treatment for adolescents with clinically significant binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge eating and associated eating disorder symptoms in a younger sample.
- Conditions
- Eating Disorder, Emotional Disorder
- Being tested
- Integrative cognitive-affective therapy for adolescents (ICAT-A)
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative cognitive-affective therapy for adolescents (ICAT-A)Behavioural
Participants will receive a 21-session individual psychotherapy approach with 4 phases. In addition, there will be 7-13 additional conjoint parent sessions.
| Study group | Role | What they receive |
|---|---|---|
| Adolescents with Eating Disorder | Experimental | Adolescents with bulimia nervosa or binge eating disorder, with one or more of their parents, will receive integrative cognitive-affective therapy for adolescents (ICAT-A). Receives: Behavioral: Integrative cognitive-affective therapy for adolescents (ICAT-A) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eating Disorder Examination (EDE)
The EDE is a semi-structured interview conducted by a trained clinician to assess the psychopathology associated with the diagnosis of an eating disorder. The EDE is rated through the use of four subscales and a global score. The four subscales are: 1) Restraint, 2) Eating concern, 3) Shape concern, 4) Weight concern. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28-day period, but some questions extend out to cover the previous 3 months. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale. To obtain an overall score, the four subscales scores are summed and the resulting total divided by the number of subscales (4). The total score can range from 0 (normal) to 6 (high eating disorder).
Measured: baseline, end of treatment (approximately 8 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2017
- Study start9 Jan 2017
- Primary completionOct 2021
- Study completionOct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Eating Disorders Association
- Responsible party
- Principal investigator, Jocelyn R. Lebow, Mayo Clinic
- Investigators
- Jocelyn R Lebow, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03324724
- Sponsor's protocol ID
- 16-008708
- Acronym
- ICAT-A
- Status last verified
- Jun 2022
- First submitted
- 5 Sep 2017
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Cognitive-Affective Therapy for Adolescent Eating Disorders (ICAT-A)
- ClinicalTrials.gov ID
- NCT03324724
- Acronym / sponsor ID
- ICAT-A / 16-008708
- Conditions
- Eating Disorder, Emotional Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Eating Disorders Association
- Study start
- 9 Jan 2017 (actual)
- Primary completion
- Oct 2021 (actual)
- Study completion
- Oct 2021 (actual)
- First posted
- 30 Oct 2017 (actual)
- 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.
Recently, Integrative Cognitive-Affective Therapy (ICAT), a novel intervention for bulimia nervosa (BN) and binge eating disorder (BED) that targets emotion regulation deficits, has shown promise in reducing eating disorder symptoms as well as improving emotion regulation capacities in adults. However, this treatment has not been investigated in an adolescent sample. Given the contributing role of emotion regulation in adolescent eating disorder symptoms and limited treatment options for adolescents with BN and BED, the aim of this study is to adapt the existing adult ICAT treatment for adolescents with clinically significant binge eating (ICAT-A) and to evaluate the extent to which ICAT-A is helpful in reducing binge eating and associated eating disorder symptoms in a younger sample.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adolescents with Eating Disorder | Experimental | Behavioral: Integrative cognitive-affective therapy for adolescents (ICAT-A)Adolescents with bulimia nervosa or binge eating disorder, with one or more of their parents, will receive integrative cognitive-affective therapy for adolescents (ICAT-A). |
Who may qualify
- Ages
- 14 to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Subject with full and sub-threshold bulimia nervosa and binge eating disorder (that is binge eating weekly)
- No major weight loss (defined as a reduction of 10% baseline body weight or more)
- Subject who meet criteria for any Diagnostic and Statistical Manual of Mental Disorders (DSM-5) eating disorder characterized by binge eating with or without compensatory behavior
- Subjects who take medications that do not directly impact weight or appetite (including Selective serotonin reuptake inhibitors (SSRI) antidepressants) will be included if their dose has been stable for at least six weeks
- Subject must be living at home
Key exclusion criteria (4 listed)
- Subject on medications that influence weight or appetite (including antipsychotic medications)
- Subject who is medically or psychiatrically unstable (defined as requiring hospitalization within the past 3 months)
- Acutely suicidal requiring current hospitalization or who meet criteria for substance use disorder in the past month
- Subjects who become or psychiatrically unstable during the study will be re-evaluated, removed from the study, and referred for appropriate treatment.
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 |
|---|---|---|
| Integrative cognitive-affective therapy for adolescents (ICAT-A)Participants will receive a 21-session individual psychotherapy approach with 4 phases. In addition, there will be 7-13 additional conjoint parent sessions. | Behavioural | Adolescents with Eating Disorder |
Primary outcome
Change in Eating Disorder Examination (EDE)
Time frame: baseline, end of treatment (approximately 8 months)
The EDE is a semi-structured interview conducted by a trained clinician to assess the psychopathology associated with the diagnosis of an eating disorder. The EDE is rated through the use of four subscales and a global score. The four subscales are: 1) Restraint, 2) Eating concern, 3) Shape concern, 4) Weight concern. The questions concern the frequency in which the patient engages in behaviors indicative of an eating disorder over a 28-day period, but some questions extend out to cover the previous 3 months. To obtain a particular subscale score, the ratings for the relevant items are added together and the sum divided by the total number of items forming the subscale. To obtain an overall score, the four subscales scores are summed and the resulting total divided by the number of subscales (4). The total score can range from 0 (normal) to 6 (high eating disorder).
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 6 Jun 2022.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Jocelyn R Lebow, PhD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Integrative cognitive-affective therapy for adolescents (ICAT-A) in people with Eating Disorder and Emotional Disorder, run by Mayo Clinic at 1 site 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 6 inclusion and 4 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 6 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 in Eating Disorder Examination (EDE) (time frame: baseline, end of treatment (approximately 8 months)). 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 6 Jun 2022.