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The Effectiveness of Acceptance and Commitment Therapy in Adolescents with Eating Disorders

Protocol summary

Study aim
This study aims to determine the effectiveness of treatment based on acceptance and commitment in adolescents with eating disorders.
Design
The present study is a randomized, double-blind, controlled clinical trial that investigates the efficacy of acceptance and commitment therapy in treating eating disorders among adolescents. The sample consists of 44 adolescent patients with eating disorders who have been selected based on availability and assigned to either the intervention or control groups (receiving psychological training for eating disorders) using a simple randomization method.
Settings and conduct
The place of research is the obesity, nutrition, and minimally invasive surgery clinic of Rasoul Akram Hospital and nutrition clinics providing services to adolescents with eating disorders. After explaining the treatment and obtaining informed consent, 44 eligible adolescent patients will be randomly assigned to two intervention groups and control
Participants/Inclusion and exclusion criteria
Eligibility criteria: An eating disorder diagnosis based on DSM-5 criteria and ages between 10 and 19 years. Exclusion criteria: the presence of severe psychiatric disorders, having serious suicidal thoughts, substance use disorder, and receiving psychological treatment interventions in the last year
Intervention groups
The intervention group receives acceptance and commitment therapy for adolescents with eating disorders in eight weekly, one-hour sessions. The intervention procedures include psychoeducation, Creative Hopelessness, control as a problem, acceptance, clarification of values, and prevention of relapse. The control group also receives the psychological training protocol for eating disorders for eight one-hour weekly sessions
Main outcome variables
Symptoms of eating disorder, inflexibility of body image, experiential avoidance, and clarification of values

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20170326033144N2
Registration date: 2023-09-24, 1402/07/02
Registration timing: registered_while_recruiting

Last update: 2023-09-24, 1402/07/02
Update count: 0
Registration date
2023-09-24, 1402/07/02
Registrant information
Name
Mohammad Javad Shabani
Name of organization / entity
Department of Clinical Psychology, Faculty of Medicine, Kashan University of Medical Sciences, Kasha
Country
Iran (Islamic Republic of)
Phone
+98 77 3325 3153
Email address
shabani-mj@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-08-23, 1402/06/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Acceptance and Commitment Therapy in Adolescents with Eating Disorders
Public title
The effect of Acceptance and Commitment Therapy on eating disorders in adolescents.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Presence of eating disorder diagnosis based on DSM-5 criteria Age between 10 and 19 years Not taking psychiatric drugs or taking anti-depressants and anti-anxiety drugs for at least two months before the intervention, the drug dose must be constant, and the patient must agree to the drug dose remaining constant during the study.
Exclusion criteria:
The presence of severe psychiatric disorders (psychotic disorders, bipolar disorder, and bipolar disorder with psychotic features) Having serious suicidal thoughts Organic brain disorder based on self-report Substance use disorder The presence of cognitive disabilities such as mental retardation Having a history of incurable physical illness such as cancer Receiving psychological treatment interventions in the last year and at the time of the research The need to change, stop or increase the drug dose or start a new drug after pre-test evaluations
Age
From 10 years old to 19 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
Participants will be randomly assigned to either the intervention group (receiving acceptance and commitment therapy) or the control group (receiving psychoeducation for eating disorders) using the simple randomization method. Simple randomization is based on a single sequence of random assignments. At first, each participant will be given a number code. Then, using the randomization software of the website https://www.sealedenvelope.com/, the participants are randomly and consecutively assigned to two groups A and B (intervention and control groups).
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding will be applied to the evaluator and statistical analyst, which means that the factors that can cause deviation of the test result will be hidden from the statistical analyst and the evaluator. Due to the nature of the research, the participants are not blinded to the research process, and due to reasons such as the fact that the therapists perform the treatments, it is practically impossible to blind the therapist
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
IR.IUMS.REC.1402.448

Health conditions studied

1

Description of health condition studied
Eating disorders
ICD-10 code
F50
ICD-10 code description
Eating disorders

Primary outcomes

1

Description
Eating disorder symptoms
Timepoint
Before and after interventions and three month follow-up
Method of measurement
Eating Disorder Examination Questionnaire (EDE-Q)

2

Description
Body mass index
Timepoint
Before and after interventions and three month follow-up
Method of measurement
weight with kilograms on a scale, height with meters with the use of a rubber meter

Secondary outcomes

1

Description
Inflexibility of body image
Timepoint
Before and after interventions and three month follow-up
Method of measurement
Body-Image Acceptance and Action Questionnaire (BA-AAQ)

2

Description
Values living
Timepoint
Before and after interventions and three month follow-up
Method of measurement
Valuing Questionnaire (VQ)

3

Description
Self-esteem
Timepoint
Before and after interventions and three month follow-up
Method of measurement
Rosenberg self-esteem scale (RSES)

4

Description
Experiential avoidance
Timepoint
Before and after interventions and three month follow-up
Method of measurement
Avoidance and Fusion Questionnaire for Youth (AFQ-Y)

5

Description
Psychological symptoms ( Depression, Anxiety, Stress)
Timepoint
Before and after interventions and three month follow-up
Method of measurement
Depression Anxiety Stress Scales – Youth Version (DASS-Y)

6

Description
Therapeutic alliance
Timepoint
Before and after interventions and three month follow-up
Method of measurement
Therapeutic Alliance Scale for Children: Youth Version

Intervention groups

1

Description
The intervention group receives acceptance and commitment therapy for adolescents with eating disorders in eight weekly, one-hour sessions. the intervention procedures include the Session 1: Establishing a therapeutic contract, introducing treatment, and writing about the harms and consequences of eating disorders. Session 2: Introducing creative hopelessness using the metaphor of "tug of war with a monster." Sessions 3 and 4: Introducing control as a problem, as well as using the "milk, milk, milk exercise" for cognitive defusion and introducing acceptance using the metaphor of "bus passengers." Sessions 5 and 6: Continuing cognitive defusion exercises, mindfulness exercises, and self-as-context exercises. Sessions 7 and 8: Explaining the values of each participant and increasing behavioral commitment for a more sustainable life. Finally, the therapist assists the participant in applying the learned exercises such as acceptance, contacting the present moment, cognitive defusion, self-as-context, and engaging in meaningful activities to prevent the return of symptoms.
Category
Treatment - Other

2

Description
The control group also receives the psychoeducational protocol for eating disorders in 8 weekly one-hour sessions. Procedures of the protocol include introducing eating disorders, prevalence and consequences of etiology of eating disorders, risk factors, prevention of relapse, and introduction of standard treatments of eating disorders.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Obesity, Nutrition, and Minimally Invasive Surgery Clinic of Rasoul Akram Hospital
Full name of responsible person
Mohammad Javad Shabani
Street address
Tehran Villa, Sattar Khan St., Niayesh St., Mansouri Kia St., Obesity, Nutrition and Minimally Invasive Surgery Clinic of Rasoul Akram Hospital
City
Tehran
Province
Tehran
Postal code
1445613113
Phone
+98 21 6650 7055
Fax
Email
shabani.mjavad@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Falak
Street address
Iran University of Medical Sciences, next to Milad Tower, Hemmat Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8862 2703
Email
falak.r@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Javad Shabani
Position
PhD student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
shabani.mjavad@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Javad Shabani
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
shabani.mjavad@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mohammad Javad Shabani
Position
Ph.D. Candidate
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
School of Behavioral Sciences and Mental Health Shahid Mansouri Street, Niyayesh Street, Satarkhan Avenue, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1445613111
Phone
+98 21 6655 1655
Email
shabani.mjavad@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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