Integrated Treatment for Co-occurring Eating Disorders and Posttraumatic Stress Disorder

May 15, 2020 updated by: Kathryn Trottier, University Health Network, Toronto

Co-occurring Eating Disorders and Posttraumatic Stress Disorder: Facilitating Full and Sustained Recovery Through Empirically-Based Concurrent Treatment

Although psychotherapy for eating disorders (EDs) can be effective, approximately 50% of those who complete a course of the best available therapy continue to have significant ED symptoms at the end of treatment. Posttraumatic stress disorder (PTSD) commonly co-occurs with EDs and is thought to be one reason why some individuals do not remit from their ED with best available treatment or relapse following treatment. In particular, ED behaviours can function as coping methods for PTSD symptoms, and thus interfere with successful and lasting ED recovery. The main objective of this initial treatment trial is to determine whether a concurrent treatment approach, in which PTSD symptoms are treated at the same time as ED symptoms, provides an advantage over standard ED treatment by successfully alleviating PTSD symptoms.

Forty participants who have both an ED and PTSD will be assigned to receive either (1) standard ED psychotherapy alone or (2) standard ED psychotherapy concurrent with PTSD psychotherapy. After treatment, participants will be followed for a period of 6 months to determine whether improvements made during therapy are maintained after treatment. ED and PTSD symptoms, as well as concomitant symptoms (e.g., anxiety and depression) will be assessed immediately before and after treatment, as well as 3 and 6 months after treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Standard ED treatment is characterized by partial response in many individuals, and the risk of relapse is high. This, in combination with significant rates of comorbid PTSD, evidence that trauma history can negatively impact ED treatment outcome, and the observation that PTSD may be a central ED maintaining factor in these individuals, has led us to develop a program of research aimed at demonstrating that the alleviation of PTSD symptoms concurrent with ED treatment facilitates a fuller and sustained ED recovery for these individuals.

The specific aims of this initial randomized controlled trial (RCT) are to determine: (1) the immediate and short-term efficacy of concurrent evidence-based ED and PTSD treatment in reducing PTSD symptoms relative to standard ED treatment; and (2) estimates of the effect sizes of concurrent treatment on ED symptomatology relative to standard ED treatment at post-treatment and follow-up.

Primary Hypothesis:

  1. Concurrent CBT for ED and PTSD will result in significantly greater improvements in clinician-rated PTSD symptoms at post-treatment, as well as at 3- and 6-month follow-up compared with CBT for ED alone.

    Secondary Hypotheses:

  2. Concurrent CBT for ED and PTSD will result in significantly greater improvements in self-reported PTSD symptoms at post-treatment, as well as at 3- and 6-month follow-up compared with CBT for ED alone.
  3. Concurrent CBT for ED and PTSD will result in significantly greater improvements in concomitant symptoms (e.g., anxiety and depression) at post-treatment, as well as at 3- and 6-month follow-up compared with CBT for ED alone.

Exploratory Research Questions

  1. What proportion of participants experience reliable improvement in ED symptomatology and what proportion experience reliable deterioration in ED symptomatology over the course of each treatment?
  2. What is the relative efficacy of concurrent CBT for ED and PTSD versus CBT for ED alone in reducing functional deficits at post-treatment, and 3- and 6-month follow-up?
  3. What is the relative efficacy of concurrent CBT for ED and PTSD versus CBT for ED alone in improving other concomitant symptoms at post-treatment, and 3- and 6-month follow-up?

METHOD:

Following a course of intensive ED treatment in the inpatient or day hospital ED program at University Health Network (UHN), participants will be randomly assigned to receive either individually-administered: (1) standard CBT for ED alone or (2) concurrent CBT for ED and PTSD. Participants in both conditions will receive 16 sessions. Eleven of the 16 concurrent CBT for ED and PTSD sessions will be 90 minutes long in order to accommodate the administration of CBT for ED and PTSD. Participants in the CBT for ED alone condition will also receive eleven 90-minute sessions in order to control for time in therapy. In the CBT for ED condition, therapists will have more time to cover the ED-related content. Accordingly, both treatments will consist of eleven 90-minute sessions and five 50-minute sessions, with two sessions per week for the first 8 sessions, weekly sessions for the following 6 sessions, and biweekly for the final two sessions.

Participants will be assessed pre-CBT for ED/PTSD and post-CBT for ED/PTSD, as well as 3 and 6 months after treatment. The assessors will be blind to treatment condition, and an intent-to-treat (ITT) approach to data collection and analysis will be adopted. ED and PTSD symptoms will also be assessed on a weekly basis during the study treatments.

STATISTICS:

  1. Primary hypothesis: Changes in clinician-rated PTSD symptoms will be analyzed using multilevel modeling, including a random effect for time and fixed effects for therapy condition, time, and the condition by time interaction. Change in PTSD symptoms over time and differences between the conditions over time will be examined. Empirically derived covariates that significantly reduce error variance will be used. Cohen's d effect sizes will be calculated.
  2. Secondary hypotheses: Changes in self-reported PTSD symptoms, anxiety, and depresion will be analyzed using multilevel modeling, including a random effect for time and fixed effects for therapy condition, time, and the condition by time interaction. Change in PTSD symptoms, anxiety, and depression over time and differences between the conditions over time will be examined. Empirically derived covariates that significantly reduce error variance will be used. Cohen's d effect sizes will be calculated.
  3. The proportion of participants who experience reliable improvement and the proportion who experience reliable deterioration in ED symptomatology in each therapy condition will be calculated using reliable change criteria (Jacobson & Truax, 1991).
  4. The proportion of participants meeting diagnostic criteria for PTSD and an eating disorder will be compared between conditions at post-treatment and follow-up.
  5. Changes in other concomitant symptoms and functional deficits will be analyzed using multilevel modeling as described above.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
43

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Eating Disorder Program; Toronto General Hospital; University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • have had a minimum dose of intensive eating disorder treatment in the Toronto General Hospital Eating Disorder Program, defined as 6 weeks or longer
  • have current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnoses of an eating disorder and PTSD
  • be on a stable (or no) psychotropic medication regimen for at least 4 weeks

Exclusion Criteria:

  • current body mass index less than 18.5
  • current substance use disorder involving dependence
  • current psychosis
  • current bipolar episode
  • medical treatment or other condition known to influence eating and/or weight
  • current participation in another psychosocial treatment for ED or trauma
  • current participation in any treatment study for ED or trauma
  • has previously received cognitive processing therapy for PTSD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: CBT for ED only
In this arm, participants will receive CBT for ED following intensive ED treatment (see intervention section for description).
Behavioral: CBT for ED
Cognitive behavior therapy (CBT) for eating disorders (ED) is a 16-session individual therapy protocol which will focus on maintaining improvements in eating following intensive treatment, as well as addressing overconcern with weight/shape. Interventions will be adopted from the Enhanced CBT for ED manual.
Other Names:
  • CBT for ED only
EXPERIMENTAL: Concurrent CBT for ED and PTSD
In this arm, participants will receive concurrent CBT for ED and PTSD following intensive treatment. (see intervention section for description).
Behavioral: Concurrent CBT for ED and PTSD
The concurrent ED and PTSD intervention will consist of 16 sessions of CBT for both PTSD and for ED (ED interventions described above). CBT for PTSD will be based on interventions in the Cognitive Processing Therapy (CPT) manual.
Other Names:
  • CBT for ED and PTSD

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in clinician-assessed PTSD symptoms
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in PTSD symptoms will be assessed using the Clinician-Administered PTSD Scale (CAPS; Weathers et al., 2013). Scores range from 0-80 with a higher score representing higher severity.
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in self-reported PTSD symptoms
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
The PTSD Checklist (PCL; Weathers, Litz, Keane, Palemeri, Marx, & Schnurr, 2013) will provide a measure of change in self-reported PTSD symptoms. Scores can range from 0-80 with a higher score indicating higher severity.
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in anxiety
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in anxiety will be assessed with the anxiety scale of the Depression Anxiety Stress Scales (DASS; Lovibond & Lovibond, 1995). Scores can range from 0-42 with a higher score reflecting higher anxiety.
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in depression
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in depression will be assessed with the depression scale of the Depression Anxiety Stress Scales (DASS; Lovibond & Lovibond, 1995). Scores can range from 0-42 with a higher score reflecting higher depression.
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in clinician-rated eating disorder (ED) symptomatology
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in clinician-rated frequency of ED symptoms and severity of ED features will be assessed via the Eating Disorder Examination (EDE; Fairburn, Cooper, & O'Connor, 2014)
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Functional deficits
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
The Social Adjustment Scale Self-Report (SASSR; Weissman & Bothwell, 1976) will provide an outcome measure of functional deficits across six primary domains: work; social and leisure activities; extended family relationships; role in spousal relationship; role in parental relationships; and role in family unit relationship. Higher scores indicate greater impairment of functioning. Scores range from 1-5.
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in self-reported eating disorder (ED) symptomatology
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in frequency of self-reported ED symptoms and severity of ED features will be assessed via the questionnaire version of the EDE (EDE-Q; Fairburn & Beglin, 2008).
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in Beck depression scores
Time Frame: pre-treatment, weekly during treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in depression symptoms will be assessed with the Beck Depression Inventory (BDI-II; Beck, Steer, & Brown, 1996). Scores can range from 0-63 with a higher score reflecting a higher level of depression.
pre-treatment, weekly during treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in emotion regulation
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Emotion regulation will be assessed with the Difficulties with Emotion Regulation Scale (DERS; Gratz & Roemer, 2004). The total score can range from 36-180, with higher scores suggesting greater emotion dysregulation. The DERS has 6 subscales.
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in shame
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Shame will be assessed using the Experiences of Shame Scale (ESS; Andrews, Qian, & Valentine, 2002). The total score can range from 25-100. The ESS has 3 subscales.
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in schematic beliefs.
Time Frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Schematic beliefs will be assessed using the Young Schema Questionnaire (YSQ; Young, 1998). The YSQ has 15 subscales and scores on the subscales range from 5-30.
pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Treatment acceptability and satisfaction
Time Frame: after session 4, end of treatment (after approximately 14 weeks)
Treatment acceptability and satisfaction will be measured with investigator constructed Likert Scales.
after session 4, end of treatment (after approximately 14 weeks)
Weekly change in self-reported PTSD symptoms
Time Frame: weekly over approximately 14 weeks
The PTSD Checklist (PCL; Weathers, Litz, Keane, Palemeri, Marx, & Schnurr, 2013) weekly version will provide a measure of change in self-reported PTSD symptoms over the course of treatment. Scores can range from 0-80 with a higher score indicating higher severity.
weekly over approximately 14 weeks
Behavioural urges over the course of treatment
Time Frame: weekly over approximately 14 weeks
Self-reported urges for eating disorder behaviours, self-injury and substance use will be assessed using an investigator-constructed questionnaire on a weekly basis over the course of therapy.
weekly over approximately 14 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2015

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 30, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 30, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 19, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REB# 15-8826-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Eating Disorder

Clinical Trials on CBT for ED

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings