Binge Eating DisorderNCT02043496
Integrative Cognitive-Affective Therapy for Binge Eating Disorder
A study testing Integrative Cognitive-Affective Therapy and CBT-Guided Self Help in people with Binge Eating Disorder, run by University of Minnesota at 2 sites in United States.
Trial summary
The purpose of the study is to test a newly developed individual psychotherapy treatment for binge eating disorder in adults. This treatment is a type of individual psychotherapy called Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their behaviors, feelings, thoughts about… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Integrative Cognitive-Affective Therapy and CBT-Guided Self Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 2 sitesUnited States
- Study dates
- Dec 2013to Aug 2017
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Binge eating disorder (DSM-5)
Who cannot join
- History of gastric bypass surgery
- Medical condition acutely affecting eating and/or weight
- Current medical and/or psychiatric instability (e.g., acute suicidality)
- Psychosis and/or bipolar disorder
- Severe cognitive impairment or developmental disability
- Inability to read English
Show all 11Show fewer
- Current substance use disorder
- Current participation in psychotherapy and/or commercial weight loss program
- Change in dosage and/or frequency of psychotropic medication in the past 6 weeks
- Pregnant or breast feeding
- BMI < 21
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Neuropsychiatric Research Institute
Fargo, North Dakota, 58107
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
The purpose of the study is to test a newly developed individual psychotherapy treatment for binge eating disorder in adults. This treatment is a type of individual psychotherapy called Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their behaviors, feelings, thoughts about themselves, and relationships. This new treatment is being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help (CBTgsh), which focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist. The primary hypothesis of this investigation is that ICAT will be associated with greater reductions in binge eating at end of treatment and follow-up compared to CBTgsh.
- Conditions
- Binge Eating Disorder
- Being tested
- Integrative Cognitive-Affective Therapy, CBT-Guided Self Help
- Keywords
- Binge Eating Disorder, Binge Eating, Eating Disorders, Obesity, Psychotherapy, Cognitive Behavioral Therapy
- Medical subject headings
- Binge-Eating Disorder, Bulimia, Feeding and Eating Disorders, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Integrative Cognitive-Affective TherapyBehavioural
Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships
CBT-Guided Self HelpBehavioural
CBT-Guided Self Help focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist.
| Study group | Role | What they receive |
|---|---|---|
| CBT-Guided Self Help | Experimental | Integrative Cognitive-Affective Therapy CBT-Guided Self Help Receives: Behavioral: CBT-Guided Self Help |
| Integrative Cognitive-Affective Therapy | Experimental | Integrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships Receives: Behavioral: Integrative Cognitive-Affective Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Episode Frequency (Eating Disorder Examination)
Frequency of binge eating as measured by the Eating Disorder Examination
Measured: 17 Weeks and 6-month Follow-up
Secondary outcomes (4)
Global Eating Disorder Symptoms (EDE)
Global Eating Disorder Symptoms as measured by the Eating Disorder Examination
Measured: 17 Weeks and 6-month follow-up
Symptoms of Depression (BDI)
Symptoms of Depression as measured by the Beck Depression Inventory
Measured: 17 Weeks and 6-month follow-up
Symptoms of Anxiety (STAI)
Symptoms of Anxiety as measured by the State-Trait Anxiety Inventory
Measured: 17 Weeks and 6-month Follow-up
Self-Esteem (RSEQ)
Self-esteem as measured by the Rosenberg Self-Esteem Questionnaire
Measured: 17 Weeks and 6-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 posted23 Jan 2014 (estimated)
- Study startDec 2013
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Responsible party
- Sponsor
- Investigators
- Carol B Peterson, PhD, Principal investigator, University of MinnesotaStephen A Wonderlich, PhD, Principal investigator, Neuropsychiatric Research Institute/University of North Dakota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02043496
- Sponsor's protocol ID
- PSYCH-2016-22310
- Status last verified
- Jul 2020
- First submitted
- 14 Jan 2014
- Last updated
- 17 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Peterson CB, Engel SG, Crosby RD, Strauman T, Smith TL, Klein M, Crow SJ, Mitchell JE, Erickson A, Cao L, Bjorlie K, Wonderlich SA. Comparing integrative cognitive-affective therapy and guided self-help cognitive-behavioral therapy to treat binge-eating disorder using standard and naturalistic momentary outcome measures: A randomized controlled trial. Int J Eat Disord. 2020 Sep;53(9):1418-1427. doi: 10.1002/eat.23324. Epub 2020 Jun 25.
PubMed 32583478
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrative Cognitive-Affective Therapy for Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT02043496
- Acronym / sponsor ID
- PSYCH-2016-22310
- Conditions
- Binge Eating Disorder
- Keywords
- Binge Eating Disorder, Binge Eating, Eating Disorders, Obesity, Psychotherapy, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Neuropsychiatric Research Institute, Fargo, North Dakota
- Study start
- Dec 2013 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 23 Jan 2014 (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.
The purpose of the study is to test a newly developed individual psychotherapy treatment for binge eating disorder in adults. This treatment is a type of individual psychotherapy called Integrative Cognitive-Affective Therapy (ICAT) that focuses on helping people change their behaviors, feelings, thoughts about themselves, and relationships. This new treatment is being compared to an existing treatment called Cognitive-Behavior Therapy-Guided Self Help (CBTgsh), which focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist. The primary hypothesis of this investigation is that ICAT will be associated with greater reductions in binge eating at end of treatment and follow-up compared to CBTgsh.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-Guided Self Help | Experimental | Behavioral: CBT-Guided Self HelpIntegrative Cognitive-Affective Therapy CBT-Guided Self Help |
| Integrative Cognitive-Affective Therapy | Experimental | Behavioral: Integrative Cognitive-Affective TherapyIntegrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Binge eating disorder (DSM-5)
Key exclusion criteria (11 listed)
- History of gastric bypass surgery
- Medical condition acutely affecting eating and/or weight
- Current medical and/or psychiatric instability (e.g., acute suicidality)
- Psychosis and/or bipolar disorder
- Severe cognitive impairment or developmental disability
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 TherapyIntegrative Cognitive-Affective Therapy is a psychotherapy treatment for binge eating that focuses on changing behaviors, feelings, thoughts, and relationships | Behavioural | Integrative Cognitive-Affective Therapy |
| CBT-Guided Self HelpCBT-Guided Self Help focuses on changing behavior patterns through the use of reading and homework assignments along with sessions with a therapist. | Behavioural | CBT-Guided Self Help |
Primary outcome
Binge Eating Episode Frequency (Eating Disorder Examination)
Time frame: 17 Weeks and 6-month Follow-up
Frequency of binge eating as measured by the Eating Disorder Examination
4 secondary outcomes
Global Eating Disorder Symptoms (EDE)
Time frame: 17 Weeks and 6-month follow-up
Symptoms of Depression (BDI)
Time frame: 17 Weeks and 6-month follow-up
Symptoms of Anxiety (STAI)
Time frame: 17 Weeks and 6-month Follow-up
Self-Esteem (RSEQ)
Time frame: 17 Weeks and 6-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 17 Jul 2020.
- Derived from this study: PubMed 32583478Peterson CB, Engel SG, Crosby RD, Strauman T, Smith TL, Klein M, Crow SJ, Mitchell JE, Erickson A, Cao L, Bjorlie K, Wonderlich SA. Comparing integrative cognitive-affective therapy and guided self-help cognitive-behavioral therapy to treat binge-eating disorder using standard and naturalistic momentary outcome measures: A randomized controlled trial. Int J Eat Disord. 2020 Sep;53(9):1418-1427. doi: 10.1002/eat.23324. Epub 2020 Jun 25.
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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.
Carol B Peterson, PhD principal investigator
University of Minnesota
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 Integrative Cognitive-Affective Therapy and CBT-Guided Self Help in people with Binge Eating Disorder, run by University of Minnesota 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 11 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 17 Jul 2020. 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?
Binge Eating Episode Frequency (Eating Disorder Examination) (time frame: 17 Weeks and 6-month Follow-up). 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 NCT02043496, which also lists 1 linked publication.
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 17 Jul 2020.