NCT03502564

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 22, 2015

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2017

Completed
5 months until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2019

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

4 years

First QC Date

November 14, 2017

Last Update Submit

May 15, 2020

Conditions

PostTraumatic Stress DisorderEating Disorder

Keywords

Posttraumatic stress disorderEating disordersCognitive behavior therapyCognitive processing therapyRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Change in clinician-assessed PTSD symptoms

    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 Outcomes (3)

  • Change in self-reported PTSD symptoms

    pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up

  • Change in anxiety

    pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up

  • Change in depression

    pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up

Other Outcomes (10)

  • Change in clinician-rated eating disorder (ED) symptomatology

    pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up

  • Functional deficits

    pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up

  • Change in self-reported eating disorder (ED) symptomatology

    pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up

  • +7 more other outcomes

Study Arms (2)

CBT for ED only

ACTIVE COMPARATOR

In this arm, participants will receive CBT for ED following intensive ED treatment (see intervention section for description).

Behavioral: CBT for ED

Concurrent CBT for ED and PTSD

EXPERIMENTAL

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

Interventions

CBT for EDBEHAVIORAL

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.

Also known as: CBT for ED only
CBT for ED only
Concurrent CBT for ED and PTSDBEHAVIORAL

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.

Also known as: CBT for ED and PTSD
Concurrent CBT for ED and PTSD

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eating Disorder Program; Toronto General Hospital; University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (11)

  • Jacobson NS, Truax P. Clinical significance: a statistical approach to defining meaningful change in psychotherapy research. J Consult Clin Psychol. 1991 Feb;59(1):12-9. doi: 10.1037//0022-006x.59.1.12.

    PMID: 2002127BACKGROUND

  • Hamblen JL, Schnurr PP, Rosenberg A, Eftekhari A. A guide to the literature on psychotherapy for PTSD. Psychiatric Annals 39(6): 348-354, 2009.

    BACKGROUND

  • Watts BV, Schnurr PP, Mayo L, Young-Xu Y, Weeks WB, Friedman MJ. Meta-analysis of the efficacy of treatments for posttraumatic stress disorder. J Clin Psychiatry. 2013 Jun;74(6):e541-50. doi: 10.4088/JCP.12r08225.

    PMID: 23842024BACKGROUND

  • Resick PA, Monson CM, Chard KM. Cognitive processing therapy: Veteran/military version. Washington, DC: Department of Veterans' Affairs. 2007 Jun.

    BACKGROUND

  • Weathers FW, Blake DD, Schnurr PP, Kaloupek DG, Marx BP, Keane TM. The clinician-administered PTSD scale for DSM-5 (CAPS-5). Interview available from the National Center for PTSD at www. ptsd. va. gov. 2013 Aug 6.

    BACKGROUND

  • Weathers FW, Litz BT, Keane TM, Palmieri PA, Marx BP, Schnurr PP. The ptsd checklist for dsm-5 (pcl-5). Scale available from the National Center for PTSD at www. ptsd. va. gov. 2013.

    BACKGROUND

  • Beck AT, Steer RA, Brown GK. Beck Depression Inventory. San Antonio, TX, United States: The psychological corporation.1996.

    BACKGROUND

  • Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. (2nd. Ed.) Sydney: Psychology Foundation. 1995.

    BACKGROUND

  • Fairburn CG, Cooper Z, O'Connor M. The Eating Disorder Examination (EDE 17). Interview available from http://www.credo-oxford.com/pdfs/EDE_17.0D.pdf. 2014.

    BACKGROUND

  • Fairburn CG, Beglin A. Eating Disorder Examination Questionnaire (EDE-Q 6.0). In C. G. Fairburn, Cognitive Behavior Therapy and Eating Disorders (pp. 309-313). New York: Guilford. 2008.

    BACKGROUND

  • Weissman MM, Bothwell S. Assessment of social adjustment by patient self-report. Arch Gen Psychiatry. 1976 Sep;33(9):1111-5. doi: 10.1001/archpsyc.1976.01770090101010.

    PMID: 962494BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticFeeding and Eating Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kathryn Trottier, PhD

    University Health Network, Toronto

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychologist

Study Record Dates

First Submitted

November 14, 2017

First Posted

April 18, 2018

Study Start

October 22, 2015

Primary Completion

October 30, 2019

Study Completion

October 30, 2019

Last Updated

May 19, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)