Ignite Creation Date:
2024-05-06 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 12:44 PM
Study NCT ID:
NCT03502564
Status:
COMPLETED
Last Update Posted:
2020-05-19
First Post:
2017-11-14
Brief Title:
Integrated Treatment for Co-occurring Eating Disorders and Posttraumatic Stress Disorder
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Co-occurring Eating Disorders and Posttraumatic Stress Disorder Facilitating Full and Sustained Recovery Through Empirically-Based Concurrent Treatment
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg anxiety and depression will be assessed immediately before and after treatment as well as 3 and 6 months after treatment
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 eg 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
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 eg 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 EDPTSD and post-CBT for EDPTSD 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 Cohens 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 Cohens 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
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 eg 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 EDPTSD and post-CBT for EDPTSD 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 Cohens 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 Cohens 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None