PostTraumatic Stress DisorderNCT03502564
Integrated Treatment for Co-occurring Eating Disorders and Posttraumatic Stress Disorder
A study testing CBT for ED and Concurrent CBT for ED and PTSD in people with PostTraumatic Stress Disorder and Eating Disorder, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- PostTraumatic Stress Disorder, Eating Disorder
- What is being tested?
- CBT for ED and Concurrent CBT for ED and PTSD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteCanada
- Study dates
- 22 Oct 2015to 30 Oct 2019
- 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Eating Disorder Program; Toronto General Hospital; University Health Network
Toronto, Ontario, M5G 2C4
About this study
Official title: 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.
Read the 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:
- 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:
- 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.
- 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
- 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?
- 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?
- 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:
- 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.
- 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.
- 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).
- The proportion of participants meeting diagnostic criteria for PTSD and an eating disorder will be compared between conditions at post-treatment and follow-up.
- Changes in other concomitant symptoms and functional deficits will be analyzed using multilevel modeling as described above.
- Conditions
- PostTraumatic Stress Disorder, Eating Disorder
- Being tested
- CBT for ED, Concurrent CBT for ED and PTSD
- Keywords
- Posttraumatic stress disorder, Eating disorders, Cognitive behavior therapy, Cognitive processing therapy, Randomized controlled trial
- Medical subject headings
- Stress Disorders, Post-Traumatic, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT for EDBehavioural
Also called CBT for ED only
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.
Concurrent CBT for ED and PTSDBehavioural
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| CBT for ED only | Active comparator | In this arm, participants will receive CBT for ED following intensive ED treatment (see intervention section for description). Receives: 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). Receives: Behavioral: Concurrent CBT for ED and PTSD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Secondary outcomes (3)
Change in self-reported PTSD symptoms
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.
Measured: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in anxiety
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.
Measured: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in depression
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.
Measured: pre-treatment, end of treatment (after approximately 14 weeks), 3- 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 posted18 Apr 2018
- Study start22 Oct 2015
- Primary completion30 Oct 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for PostTraumatic Stress DisorderStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathryn Trottier, University Health Network, Toronto
- Investigators
- Kathryn Trottier, PhD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03502564
- Sponsor's protocol ID
- REB# 15-8826-A
- Status last verified
- May 2020
- First submitted
- 14 Nov 2017
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 2002127Hamblen JL, Schnurr PP, Rosenberg A, Eftekhari A. A guide to the literature on psychotherapy for PTSD. Psychiatric Annals 39(6): 348-354, 2009.
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.
PubMed 23842024Resick PA, Monson CM, Chard KM. Cognitive processing therapy: Veteran/military version. Washington, DC: Department of Veterans' Affairs. 2007 Jun.
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.
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.
Beck AT, Steer RA, Brown GK. Beck Depression Inventory. San Antonio, TX, United States: The psychological corporation.1996.
Lovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. (2nd. Ed.) Sydney: Psychology Foundation. 1995.
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.
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.
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.
PubMed 962494
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-occurring Eating Disorders and Posttraumatic Stress Disorder: Facilitating Full and Sustained Recovery Through Empirically-Based Concurrent Treatment
- ClinicalTrials.gov ID
- NCT03502564
- Acronym / sponsor ID
- REB# 15-8826-A
- Conditions
- PostTraumatic Stress Disorder, Eating Disorder
- Keywords
- Posttraumatic stress disorder, Eating disorders, Cognitive behavior therapy, Cognitive processing therapy, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 22 Oct 2015 (actual)
- Primary completion
- 30 Oct 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 18 Apr 2018 (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.
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.
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:
- 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:
- 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.
- 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
- 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?
- 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?
- 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:
- 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.
- 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.
- 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).
- The proportion of participants meeting diagnostic criteria for PTSD and an eating disorder will be compared between conditions at post-treatment and follow-up.
- Changes in other concomitant symptoms and functional deficits will be analyzed using multilevel modeling as described above.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT for ED only | Active comparator | Behavioral: CBT for EDIn this arm, participants will receive CBT for ED following intensive ED treatment (see intervention section for description). |
| Concurrent CBT for ED and PTSD | Experimental | Behavioral: Concurrent CBT for ED and PTSDIn this arm, participants will receive concurrent CBT for ED and PTSD following intensive treatment. (see intervention section for description). |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| CBT for EDAlso: CBT for ED onlyCognitive 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. | Behavioural | CBT for ED only |
| Concurrent CBT for ED and PTSDAlso: CBT for ED and PTSDThe 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. | Behavioural | Concurrent CBT for ED and PTSD |
Primary outcome
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.
3 secondary outcomes
Change in self-reported PTSD symptoms
Time frame: 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 depression
Time frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- 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 19 May 2020.
- Background: PubMed 2002127Jacobson 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.
- BackgroundHamblen JL, Schnurr PP, Rosenberg A, Eftekhari A. A guide to the literature on psychotherapy for PTSD. Psychiatric Annals 39(6): 348-354, 2009.
- Background: PubMed 23842024Watts 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.
- BackgroundResick PA, Monson CM, Chard KM. Cognitive processing therapy: Veteran/military version. Washington, DC: Department of Veterans' Affairs. 2007 Jun.
- BackgroundWeathers 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.
- BackgroundWeathers 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.
- BackgroundBeck AT, Steer RA, Brown GK. Beck Depression Inventory. San Antonio, TX, United States: The psychological corporation.1996.
- BackgroundLovibond SH, Lovibond PF. Manual for the Depression Anxiety Stress Scales. (2nd. Ed.) Sydney: Psychology Foundation. 1995.
- BackgroundFairburn 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.
- BackgroundFairburn 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: PubMed 962494Weissman 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.
- 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.
Kathryn Trottier, PhD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT for ED and Concurrent CBT for ED and PTSD in people with PostTraumatic Stress Disorder and Eating Disorder, run by University Health Network, Toronto at 1 site in Canada.
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 3 inclusion and 8 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 19 May 2020. 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 Canada. 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 clinician-assessed PTSD symptoms (time frame: pre-treatment, end of treatment (after approximately 14 weeks), 3- 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 NCT03502564, which also lists 11 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 19 May 2020.