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Online CBT Intervention for Students With Adjustment Disorder (Online CBT)

Primary Purpose

Adjustment Disorders

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Internet CBT-UP intervention iCBT-UP
Internet Progressive Muscle Realxation Training (iPMR)
Sponsored by
University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adjustment Disorders focused on measuring adjustment disorder, students, internet psychological interventions, cognitive behavioural therapy

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: having a student status 18 years old or older, having access to the internet and using computer or smartphone, meeting the diagnostic criteria of adjustment disorder based on a total sum score > 47,5 in ADNM-20 questionnaire meeting diagnostic criteria for AjD in MINI Interview. Exclusion Criteria: an increased risk of suicidality intent or ideation (at least moderate scores on the MINI and/or a score > 2 on item 9 from the PHQ-9), psychotic disorder, eating disorder, anti-social personality disorder and/or alcohol/substance use disorder as indicated by the MINI receiving another psychological treatment at the start of the study having no time for participation in program receiving pharmacological psychiatric treatment not stabilized 6 weeks prior the start of the study

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    No Intervention

    Arm Label

    Internet CBT-UP intervention (iCBT-UP)

    Internet Progressive Muscle Realxation Training (iPMR)

    Waiting List

    Arm Description

    Patricipants in the experimental group will receive online cbt intervention for students with adjustment disorder (iCBT-UP).

    Participants from the active control group will receive progressive muscle relaxation training (iPMR).

    Participants from the waiting list condition will receive access to the choosen intervention after 6-weeks waiting period.

    Outcomes

    Primary Outcome Measures

    Change in Adjustment disorder
    Adjustment disorder - The Adjustment Disorder New Module 20 (ADNM-20)

    Secondary Outcome Measures

    Change in Depression
    The patient health questionnaire-9 (PHQ-9)
    Change in General Anxiety Disorder
    General Anxiety Disorder-7 (GAD-7)
    Change in Stress
    Scale of experienced stress (PSS-10)
    Change in Satisfaction with life
    Satisfaction with life scale (SWLS)
    Change in Academic Adjustment
    Academic adjustment scale (AAS)
    Change in Experiential Avoidance
    Acceptance and Action Questionnaire
    Change in Cognitive Fusion
    Cognitive Fusion Questionnaire (CFQ)
    Change in Self-compassion
    Self Compassion Scale - Short Form (SCS-SF)
    Change in Mindfulness
    Five Facet Mindfulness Questionnaire (FFMQ-15)
    Change in Persevative thinking
    Perseverative Thinking Questionnaire (PTQ)
    Change in Mental well-being
    Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
    Change in Cognitive functioning
    Stroop Task (color-word)
    Change in Academic performance
    This index will be based on a three recently received grades. The mean will be assessed.
    Change in Daily Depressogenic adjustment
    Measured in daily diaries. It will be measured by three items based on Becks triad.
    Change in Daily negative thinking
    Measured in daily diaries. Rumination and worrying. Daily worry measures will be measured with three items taken from Meyer et al. (1990).
    Change in Emotional regulation
    Measured in daily diaries. cognitive restructuring and emotional supression. This variables will be measured using one item (each scale) from Emotional Regulation Questionnaire (ERQ).
    Change in Self-compassion
    Measured in daily diaries, by three items from Self Compassion Scale (SCS).
    Change in Daily-affect
    Measured in daily diaries, based on circumplex model.
    Change in Procrastination
    Measured in daily diaries, by three items from The Pure Procrastination scale.

    Full Information

    First Posted
    February 13, 2023
    Last Updated
    March 16, 2023
    Sponsor
    University of Warsaw
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05768308
    Brief Title
    Online CBT Intervention for Students With Adjustment Disorder
    Acronym
    Online CBT
    Official Title
    Effectiveness and Mediators of Change of an Online CBT Intervention for Students With Adjustment Disorder - Study Protocol for a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    May 2023 (Anticipated)
    Primary Completion Date
    May 2023 (Anticipated)
    Study Completion Date
    September 2023 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate the effectiveness of online cognitive-behavioral intervention based on Unified Protocol and mediators of obtained changes among polish students with adjustment disorder. The intervention is fully self-helped and based on Unified Protocol principles. Control conditions contain of online progressive muscle relaxation group and waiting list.
    Detailed Description
    Adjustment problems are highly prevalent among students around the world (Conley et.al., 2013). Unfortunately only half of students in need receive psychological help (Eisenberg et al., 2018). For these reasons, there is a need to develop and evaluate new, more scalable forms of treatment for students with adjustment disorder - such as internet therapeutic programs. Therefore the aim of the present research is to evaluate the effectiveness of online cognitive-behavioural therapy intervention. Mediators of obtained changes will also be evaluated. The present study has a potential for the development of a scalable, well researched treatment option for students experiencing adjustment disorder - internet psychological intervention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adjustment Disorders
    Keywords
    adjustment disorder, students, internet psychological interventions, cognitive behavioural therapy

    7. Study Design

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

    8. Arms, Groups, and Interventions

    Arm Title
    Internet CBT-UP intervention (iCBT-UP)
    Arm Type
    Experimental
    Arm Description
    Patricipants in the experimental group will receive online cbt intervention for students with adjustment disorder (iCBT-UP).
    Arm Title
    Internet Progressive Muscle Realxation Training (iPMR)
    Arm Type
    Active Comparator
    Arm Description
    Participants from the active control group will receive progressive muscle relaxation training (iPMR).
    Arm Title
    Waiting List
    Arm Type
    No Intervention
    Arm Description
    Participants from the waiting list condition will receive access to the choosen intervention after 6-weeks waiting period.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet CBT-UP intervention iCBT-UP
    Intervention Description
    The self-helped internet intervention for students experiencing emotional difficulties, especially adjustment disorder. This intervention is based on transdiagnostic cbt principles - unified protocol (Barlow et al., 2018). It is a modular intervention consisting of six modules teaching different skills of dealing with emotions. Intervention is interactive and contains of video materials, quizes, texts and audio materials.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Internet Progressive Muscle Realxation Training (iPMR)
    Intervention Description
    Participants from the active control group will receive progressive muscle relaxation training (iPMR) (Bernstein, Borkovec, Hazlett-Stevens, 2000). It is also a modular intervention and, similar to the i-cbt condition, consists of 5 modules. During the intervention, participants learn how to progressively tighten and relax different muscle groups.The first module is planned for two weeks and the rest of them for one week each. Intervention consists of video materials and audio guided relaxations. Participants are encouraged to train these relaxations once a day.
    Primary Outcome Measure Information:
    Title
    Change in Adjustment disorder
    Description
    Adjustment disorder - The Adjustment Disorder New Module 20 (ADNM-20)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Secondary Outcome Measure Information:
    Title
    Change in Depression
    Description
    The patient health questionnaire-9 (PHQ-9)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in General Anxiety Disorder
    Description
    General Anxiety Disorder-7 (GAD-7)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Stress
    Description
    Scale of experienced stress (PSS-10)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Satisfaction with life
    Description
    Satisfaction with life scale (SWLS)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Academic Adjustment
    Description
    Academic adjustment scale (AAS)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Experiential Avoidance
    Description
    Acceptance and Action Questionnaire
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Cognitive Fusion
    Description
    Cognitive Fusion Questionnaire (CFQ)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Self-compassion
    Description
    Self Compassion Scale - Short Form (SCS-SF)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Mindfulness
    Description
    Five Facet Mindfulness Questionnaire (FFMQ-15)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Persevative thinking
    Description
    Perseverative Thinking Questionnaire (PTQ)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Mental well-being
    Description
    Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Cognitive functioning
    Description
    Stroop Task (color-word)
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Academic performance
    Description
    This index will be based on a three recently received grades. The mean will be assessed.
    Time Frame
    measured at baseline, immediately after the interventions and 1 month follow up
    Title
    Change in Daily Depressogenic adjustment
    Description
    Measured in daily diaries. It will be measured by three items based on Becks triad.
    Time Frame
    7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
    Title
    Change in Daily negative thinking
    Description
    Measured in daily diaries. Rumination and worrying. Daily worry measures will be measured with three items taken from Meyer et al. (1990).
    Time Frame
    7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
    Title
    Change in Emotional regulation
    Description
    Measured in daily diaries. cognitive restructuring and emotional supression. This variables will be measured using one item (each scale) from Emotional Regulation Questionnaire (ERQ).
    Time Frame
    7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
    Title
    Change in Self-compassion
    Description
    Measured in daily diaries, by three items from Self Compassion Scale (SCS).
    Time Frame
    7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
    Title
    Change in Daily-affect
    Description
    Measured in daily diaries, based on circumplex model.
    Time Frame
    7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
    Title
    Change in Procrastination
    Description
    Measured in daily diaries, by three items from The Pure Procrastination scale.
    Time Frame
    7 days during the first week of the intervention and 7 days during the sixth week of the intervention time

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: having a student status 18 years old or older, having access to the internet and using computer or smartphone, meeting the diagnostic criteria of adjustment disorder based on a total sum score > 47,5 in ADNM-20 questionnaire meeting diagnostic criteria for AjD in MINI Interview. Exclusion Criteria: an increased risk of suicidality intent or ideation (at least moderate scores on the MINI and/or a score > 2 on item 9 from the PHQ-9), psychotic disorder, eating disorder, anti-social personality disorder and/or alcohol/substance use disorder as indicated by the MINI receiving another psychological treatment at the start of the study having no time for participation in program receiving pharmacological psychiatric treatment not stabilized 6 weeks prior the start of the study
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Aleksandra Juszczyk-Kalina, Msc
    Phone
    22 554 97 05
    Ext
    +48
    Email
    a.juszczyk@uw.edu.pl
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Aleksandra Juszczyk-Kalina, Msc
    Organizational Affiliation
    University of Warsaw
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Online CBT Intervention for Students With Adjustment Disorder

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