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Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition

Primary Purpose

Eating Disorders, Bulimia

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet-delivered CBT
Sponsored by
Linkoeping University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders focused on measuring emotional eating, restrictive eating, body dissatisfaction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Have reoccurring eating disorder uns or bulimia
  • BMI above 17,5

Exclusion Criteria:

  • Suicide prone
  • Ongoing psychological treatment

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Treatment group

    Control group

    Arm Description

    Internet-delivered CBT

    Waitlist control

    Outcomes

    Primary Outcome Measures

    Eating Disorders Examination Questionnaire

    Secondary Outcome Measures

    Quality of Life Inventory (QOLI)
    Body Shape Questionnaire (BSQ)
    Patient Health Questionnaire (PHQ-9)
    Generalised Axiety Disorder Assessment (GAD-7)
    Satisfaction With Life Scales (SWLS)
    Expectancy/Credibility Questionnaire (CEQ)

    Full Information

    First Posted
    October 26, 2015
    Last Updated
    March 6, 2017
    Sponsor
    Linkoeping University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02700620
    Brief Title
    Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition
    Official Title
    Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2015 (undefined)
    Primary Completion Date
    June 2017 (Anticipated)
    Study Completion Date
    December 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Linkoeping University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Background: Previous studies on Internet-based treatment with eating disorders have shown promising results. Objective: The first aim of this study was to investigate the effects of a tailored therapist guided internet-based treatment for individuals with eating disorders. The second aim was to examine the role of knowledge acquisition. Method: 138 participants were recruited. Screening consisted of online questionnaires followed by a telephone interview. A total of 92 participants were included after a semi-structured diagnostic interview and randomized to an 8 week treatment program (n=46) or to a control condition (n=46). Treatment consisted of individually prescribed cognitive behaviour therapy text modules in conjunction with online therapist guidance. The control group consisted of a waitlist who later received treatment.
    Detailed Description
    As above

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Eating Disorders, Bulimia
    Keywords
    emotional eating, restrictive eating, body dissatisfaction

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    92 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Treatment group
    Arm Type
    Experimental
    Arm Description
    Internet-delivered CBT
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Waitlist control
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet-delivered CBT
    Intervention Description
    Guided internet treatment
    Primary Outcome Measure Information:
    Title
    Eating Disorders Examination Questionnaire
    Time Frame
    post (8 weeks)
    Secondary Outcome Measure Information:
    Title
    Quality of Life Inventory (QOLI)
    Time Frame
    Pre and post (8 weeks)
    Title
    Body Shape Questionnaire (BSQ)
    Time Frame
    post (8 weeks)
    Title
    Patient Health Questionnaire (PHQ-9)
    Time Frame
    post (8 weeks)
    Title
    Generalised Axiety Disorder Assessment (GAD-7)
    Time Frame
    post (8 weeks)
    Title
    Satisfaction With Life Scales (SWLS)
    Time Frame
    post (8 weeks)
    Title
    Expectancy/Credibility Questionnaire (CEQ)
    Time Frame
    post (8 weeks)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Have reoccurring eating disorder uns or bulimia BMI above 17,5 Exclusion Criteria: Suicide prone Ongoing psychological treatment

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Plan Description
    Primary outcomes and background info on request.
    Citations:
    PubMed Identifier
    28711113
    Citation
    Strandskov SW, Ghaderi A, Andersson H, Parmskog N, Hjort E, Warn AS, Jannert M, Andersson G. Effects of Tailored and ACT-Influenced Internet-Based CBT for Eating Disorders and the Relation Between Knowledge Acquisition and Outcome: A Randomized Controlled Trial. Behav Ther. 2017 Sep;48(5):624-637. doi: 10.1016/j.beth.2017.02.002. Epub 2017 Mar 2.
    Results Reference
    derived

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    Individually Tailored Web-based Cbt for Eating Disorders and the Role of Knowledge Acquisition

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