Eating DisordersNCT00773617
Testing an Alternative Therapy for Bulimia Nervosa
A study testing ICAT and CBT in people with Eating Disorders, run by Neuropsychiatric Research Institute, Fargo, North Dakota at 2 sites in United States.
Trial summary
This study will compare a new method of treatment for bulimia nervosa (ICAT), integrative cognitive-affective therapy, to the current standard method of treatment, cognitive behavioral therapy (CBT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Eating Disorders
- What is being tested?
- ICAT and CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to Apr 2011
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Bulimia nervosa, as defined by DSM-IV, or bulimic symptoms, as defined as purging episodes (with objective or subjective binge eating) that occur at least once per week for the past 3 months
Who cannot join
- Past or current diagnosis of psychosis or bipolar disorder
- Inability to read English
- Medical instability, including electrolyte abnormalities
- Psychotherapy or pharmacotherapy initiated within 6 weeks of study entry
- Pregnant or lactating
- Drug or alcohol dependence in the past 6 months or drug or alcohol abuse in the past 6 weeks
- Severe cognitive impairment or mental retardation
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Neuropsychiatric Research Institute
Fargo, North Dakota, 58103
University of Minnesota Eating Disorders Research Program
Minneapolis, Minnesota, 55454
About this study
Official title: Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)
This study will compare a new method of treatment for bulimia nervosa (ICAT), integrative cognitive-affective therapy, to the current standard method of treatment, cognitive behavioral therapy (CBT).
Read the detailed description
Bulimia nervosa (BN) is a disorder characterized by binge eating and compensatory behaviors, such as self-induced vomiting or laxative abuse. It affects 1% to 2% of adolescents and young women, and occurs more rarely in men. People who suffer from BN are also more likely to suffer from other psychiatric disorders, such as anxiety disorders, mood disorders, substance abuse disorders, and personality disorders-those categorized as Axis II in the DSM IV.
Integrative cognitive-affective therapy (ICAT) is a new treatment developed as an alternative to cognitive behavioral therapy (CBT) for treating people with BN. CBT is the standard treatment for BN. ICAT uses some elements from CBT and some elements from therapies used to treat other disorders. Some elements of ICAT are also used to treat substance abuse disorders, depression, and personality disorders. This study will compare the effectiveness of ICAT and CBT in treating BN.
Participants in this study, who must have BN symptoms, will be randomly assigned to receive either CBT or ICAT treatment. Participation in this study will last 18 weeks for participants assigned to receive CBT and 16 weeks for participants assigned to receive ICAT. Both treatments will consist of 20 individual therapy sessions lasting 50 minutes. Additionally, participants receiving ICAT will receive personal digital assistant (PDA) devices installed with therapeutic modules. Use of these modules will be unlimited during the period of ICAT treatment and will be recorded at study visits. Over the course of 2 screening visits, participants will complete questionnaires, undergo clinical interviews, and go through a medical screening that involves a blood test of electrolytes and a urine test for pregnancy. Each screening visit will take 2 to 3 hours. At the end of treatment and 4 months after treatment completion, participants will undergo 2 assessments, both of which will include 2 hours of interviews and questionnaires. During these assessments researchers will evaluate weight; eating behavior; and associated problems with mood, anxiety, obsessive-compulsive symptoms, self-concept, social adjustment, and other areas of psychosocial functioning.
- Conditions
- Eating Disorders
- Being tested
- ICAT, CBT
- Keywords
- Bulimia Nervosa, Treatment Efficacy, Integrative Cognitive Affective Therapy, Cognitive Behavior Therapy
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICATBehavioural
ICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior.
CBTBehavioural
CBT is a highly structured, manual-based psychotherapy that has been shown to be effective in the treatment of BN. CBT focuses on cognitions and bulimic behavior.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Integrative cognitive affective therapy (ICAT) Receives: Behavioral: ICAT |
| 2 | Active comparator | Cognitive behavioral therapy (CBT) Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent reduction in binging or purging frequency as defined by symptom recall (SR)
Measured: Measured at baseline, weekly intervals throughout the duration of therapy, end of treatment, and 32-week follow-up
Percent reduction in binging or purging frequency, as defined by the Eating Disorders Examination (EDE)
Measured: Measured at baseline, end of treatment, and 32-week follow-up
Secondary outcomes (7)
Reduction in depression, as defined by the Beck Depression Inventory (BDI)
Measured: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
Reduction in anxiety as defined by the State-Trait Anxiety Inventory (STAI)
Measured: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
Abstinence from binging and purging behavior, as defined by SR and EDE
Measured: Measured at the end of treatment and 32-week follow-up
Study retention rates
Measured: Measured weekly throughout treatment
Patient and therapist satisfaction, as defined by the Treatment Acceptability, Feasibility and Satisfaction Scale (TAFSQ)
Measured: Measured at therapy session two, therapy session eight, end of treatment, and 32-week follow-up
Self-esteem, as defined by the Rosenberg Self Esteem Questionnaire (RSEQ)
Measured: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
Self-discrepancy, as defined by the Selves Interview
Measured: Measured at baseline, end of treatment, and at 32-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2008 (estimated)
- Study startMar 2009
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies 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
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Stephen A. Wonderlich, PhD, Principal investigator, Neuropsychiatric Research Institute, University of North Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00773617
- Sponsor's protocol ID
- R34MH077571
- Other IDs
- R34MH077571, 5R34MH077571-02
- Status last verified
- Apr 2013
- First submitted
- 15 Oct 2008
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peterson CB, Berg KC, Crosby RD, Lavender JM, Accurso EC, Ciao AC, Smith TL, Klein M, Mitchell JE, Crow SJ, Wonderlich SA. The effects of psychotherapy treatment on outcome in bulimia nervosa: Examining indirect effects through emotion regulation, self-directed behavior, and self-discrepancy within the mediation model. Int J Eat Disord. 2017 Jun;50(6):636-647. doi: 10.1002/eat.22669. Epub 2017 Jan 24.
PubMed 28117906Haynos AF, Pearson CM, Utzinger LM, Wonderlich SA, Crosby RD, Mitchell JE, Crow SJ, Peterson CB. Empirically derived personality subtyping for predicting clinical symptoms and treatment response in bulimia nervosa. Int J Eat Disord. 2017 May;50(5):506-514. doi: 10.1002/eat.22622. Epub 2016 Sep 9.
PubMed 27611235Accurso EC, Wonderlich SA, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Berg KC, Peterson CB. Predictors and moderators of treatment outcome in a randomized clinical trial for adults with symptoms of bulimia nervosa. J Consult Clin Psychol. 2016 Feb;84(2):178-84. doi: 10.1037/ccp0000073. Epub 2015 Dec 21.
PubMed 26689304Accurso EC, Fitzsimmons-Craft EE, Ciao A, Cao L, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Wonderlich SA, Peterson CB. Therapeutic alliance in a randomized clinical trial for bulimia nervosa. J Consult Clin Psychol. 2015 Jun;83(3):637-42. doi: 10.1037/ccp0000021. Epub 2015 Apr 20.
PubMed 25894667Wonderlich SA, Peterson CB, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ. A randomized controlled comparison of integrative cognitive-affective therapy (ICAT) and enhanced cognitive-behavioral therapy (CBT-E) for bulimia nervosa. Psychol Med. 2014 Feb;44(3):543-53. doi: 10.1017/S0033291713001098. Epub 2013 May 23.
PubMed 23701891
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Cognitive Affective Therapy for Bulimia Nervosa (ICAT)
- ClinicalTrials.gov ID
- NCT00773617
- Acronym / sponsor ID
- R34MH077571
- Conditions
- Eating Disorders
- Keywords
- Bulimia Nervosa, Treatment Efficacy, Integrative Cognitive Affective Therapy, Cognitive Behavior Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Neuropsychiatric Research Institute, Fargo, North DakotaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 16 Oct 2008 (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.
This study will compare a new method of treatment for bulimia nervosa (ICAT), integrative cognitive-affective therapy, to the current standard method of treatment, cognitive behavioral therapy (CBT).
Detailed description
Bulimia nervosa (BN) is a disorder characterized by binge eating and compensatory behaviors, such as self-induced vomiting or laxative abuse. It affects 1% to 2% of adolescents and young women, and occurs more rarely in men. People who suffer from BN are also more likely to suffer from other psychiatric disorders, such as anxiety disorders, mood disorders, substance abuse disorders, and personality disorders-those categorized as Axis II in the DSM IV.
Integrative cognitive-affective therapy (ICAT) is a new treatment developed as an alternative to cognitive behavioral therapy (CBT) for treating people with BN. CBT is the standard treatment for BN. ICAT uses some elements from CBT and some elements from therapies used to treat other disorders. Some elements of ICAT are also used to treat substance abuse disorders, depression, and personality disorders. This study will compare the effectiveness of ICAT and CBT in treating BN.
Participants in this study, who must have BN symptoms, will be randomly assigned to receive either CBT or ICAT treatment. Participation in this study will last 18 weeks for participants assigned to receive CBT and 16 weeks for participants assigned to receive ICAT. Both treatments will consist of 20 individual therapy sessions lasting 50 minutes. Additionally, participants receiving ICAT will receive personal digital assistant (PDA) devices installed with therapeutic modules. Use of these modules will be unlimited during the period of ICAT treatment and will be recorded at study visits. Over the course of 2 screening visits, participants will complete questionnaires, undergo clinical interviews, and go through a medical screening that involves a blood test of electrolytes and a urine test for pregnancy. Each screening visit will take 2 to 3 hours. At the end of treatment and 4 months after treatment completion, participants will undergo 2 assessments, both of which will include 2 hours of interviews and questionnaires. During these assessments researchers will evaluate weight; eating behavior; and associated problems with mood, anxiety, obsessive-compulsive symptoms, self-concept, social adjustment, and other areas of psychosocial functioning.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: ICATIntegrative cognitive affective therapy (ICAT) |
| 2 | Active comparator | Behavioral: CBTCognitive behavioral therapy (CBT) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Bulimia nervosa, as defined by DSM-IV, or bulimic symptoms, as defined as purging episodes (with objective or subjective binge eating) that occur at least once per week for the past 3 months
Key exclusion criteria (7 listed)
- Past or current diagnosis of psychosis or bipolar disorder
- Inability to read English
- Medical instability, including electrolyte abnormalities
- Psychotherapy or pharmacotherapy initiated within 6 weeks of study entry
- Pregnant or lactating
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 |
|---|---|---|
| ICATICAT is a new manual-based psychotherapy treatment for bulimia nervosa (BN) that focuses on emotions and bulimic behavior. | Behavioural | 1 |
| CBTCBT is a highly structured, manual-based psychotherapy that has been shown to be effective in the treatment of BN. CBT focuses on cognitions and bulimic behavior. | Behavioural | 2 |
Primary outcome
Percent reduction in binging or purging frequency as defined by symptom recall (SR)
Time frame: Measured at baseline, weekly intervals throughout the duration of therapy, end of treatment, and 32-week follow-up
Percent reduction in binging or purging frequency, as defined by the Eating Disorders Examination (EDE)
Time frame: Measured at baseline, end of treatment, and 32-week follow-up
7 secondary outcomes
Reduction in depression, as defined by the Beck Depression Inventory (BDI)
Time frame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
Reduction in anxiety as defined by the State-Trait Anxiety Inventory (STAI)
Time frame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
Abstinence from binging and purging behavior, as defined by SR and EDE
Time frame: Measured at the end of treatment and 32-week follow-up
Study retention rates
Time frame: Measured weekly throughout treatment
Patient and therapist satisfaction, as defined by the Treatment Acceptability, Feasibility and Satisfaction Scale (TAFSQ)
Time frame: Measured at therapy session two, therapy session eight, end of treatment, and 32-week follow-up
Self-esteem, as defined by the Rosenberg Self Esteem Questionnaire (RSEQ)
Time frame: Measured at baseline, therapy session eight, end of treatment, and 32-week follow-up
Self-discrepancy, as defined by the Selves Interview
Time frame: Measured at baseline, end of treatment, and at 32-week 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 29 Mar 2018.
- Derived from this study: PubMed 28117906Peterson CB, Berg KC, Crosby RD, Lavender JM, Accurso EC, Ciao AC, Smith TL, Klein M, Mitchell JE, Crow SJ, Wonderlich SA. The effects of psychotherapy treatment on outcome in bulimia nervosa: Examining indirect effects through emotion regulation, self-directed behavior, and self-discrepancy within the mediation model. Int J Eat Disord. 2017 Jun;50(6):636-647. doi: 10.1002/eat.22669. Epub 2017 Jan 24.
- Derived from this study: PubMed 27611235Haynos AF, Pearson CM, Utzinger LM, Wonderlich SA, Crosby RD, Mitchell JE, Crow SJ, Peterson CB. Empirically derived personality subtyping for predicting clinical symptoms and treatment response in bulimia nervosa. Int J Eat Disord. 2017 May;50(5):506-514. doi: 10.1002/eat.22622. Epub 2016 Sep 9.
- Derived from this study: PubMed 26689304Accurso EC, Wonderlich SA, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Berg KC, Peterson CB. Predictors and moderators of treatment outcome in a randomized clinical trial for adults with symptoms of bulimia nervosa. J Consult Clin Psychol. 2016 Feb;84(2):178-84. doi: 10.1037/ccp0000073. Epub 2015 Dec 21.
- Derived from this study: PubMed 25894667Accurso EC, Fitzsimmons-Craft EE, Ciao A, Cao L, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ, Wonderlich SA, Peterson CB. Therapeutic alliance in a randomized clinical trial for bulimia nervosa. J Consult Clin Psychol. 2015 Jun;83(3):637-42. doi: 10.1037/ccp0000021. Epub 2015 Apr 20.
- Derived from this study: PubMed 23701891Wonderlich SA, Peterson CB, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ. A randomized controlled comparison of integrative cognitive-affective therapy (ICAT) and enhanced cognitive-behavioral therapy (CBT-E) for bulimia nervosa. Psychol Med. 2014 Feb;44(3):543-53. doi: 10.1017/S0033291713001098. Epub 2013 May 23.
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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.
Stephen A. Wonderlich, PhD principal investigator
Neuropsychiatric Research Institute, University of North Dakota
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICAT and CBT in people with Eating Disorders, run by Neuropsychiatric Research Institute, Fargo, North Dakota 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 1 inclusion and 7 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 29 Mar 2018. 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?
Percent reduction in binging or purging frequency as defined by symptom recall (SR) (time frame: Measured at baseline, weekly intervals throughout the duration of therapy, end of treatment, and 32-week follow-up). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00773617, which also lists 5 linked publications.
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 29 Mar 2018.