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Status unknownNCT05768308Online CBTUpdated Mar 21, 2023

Online CBT Intervention for Students With Adjustment Disorder

An interventional study of Internet CBT-UP intervention iCBT-UP and Internet Progressive Muscle Realxation Training (iPMR) in Adjustment Disorders, sponsored by University of Warsaw. Status unknown. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2023-03-21.

Sponsored by University of Warsaw · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Adjustment Disorders

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Keywords

  • adjustment disorder
  • students
  • internet psychological interventions
  • cognitive behavioural therapy
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In context

Adjustment Disorders

63 studies on the registry are indexed under Adjustment Disorders; 13 are open to participants now.

This study's planned enrollment of 216 is above the median of 100 across 52 interventional studies indexed under Adjustment Disorders.

Browse Adjustment Disorders studies →

Lead sponsor

University of Warsaw is the lead sponsor of 5 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
216 participants (estimated)

Study arms

  • Experimental
    Internet CBT-UP intervention (iCBT-UP)

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

    Behavioral: Internet CBT-UP intervention iCBT-UP

  • Active comparator
    Internet Progressive Muscle Realxation Training (iPMR)

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

    Behavioral: Internet Progressive Muscle Realxation Training (iPMR)

  • No intervention
    Waiting List

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

Interventions

  • BehavioralInternet CBT-UP intervention iCBT-UP

    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.

  • BehavioralInternet Progressive Muscle Realxation Training (iPMR)

    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.

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What researchers measure

Primary outcomes

  1. Change in Adjustment disorder

    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 outcomes

  1. Change in Depression

    The patient health questionnaire-9 (PHQ-9)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  2. Change in General Anxiety Disorder

    General Anxiety Disorder-7 (GAD-7)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  3. Change in Stress

    Scale of experienced stress (PSS-10)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  4. Change in Satisfaction with life

    Satisfaction with life scale (SWLS)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  5. Change in Academic Adjustment

    Academic adjustment scale (AAS)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  6. Change in Experiential Avoidance

    Acceptance and Action Questionnaire

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  7. Change in Cognitive Fusion

    Cognitive Fusion Questionnaire (CFQ)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  8. Change in Self-compassion

    Self Compassion Scale - Short Form (SCS-SF)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  9. Change in Mindfulness

    Five Facet Mindfulness Questionnaire (FFMQ-15)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  10. Change in Persevative thinking

    Perseverative Thinking Questionnaire (PTQ)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  11. Change in Mental well-being

    Warwick-Edinburgh Mental Well-being Scale (WEMWBS)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  12. Change in Cognitive functioning

    Stroop Task (color-word)

    Time frame: measured at baseline, immediately after the interventions and 1 month follow up

  13. Change in Academic performance

    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

  14. Change in Daily Depressogenic adjustment

    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

  15. 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).

    Time frame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time

  16. 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).

    Time frame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time

  17. Change in Self-compassion

    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

  18. Change in Daily-affect

    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

  19. Change in Procrastination

    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

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05768308
Lead sponsor
University of Warsaw
Responsible party
Aleksandra Juszczyk (Msc Aleksandra Juszczyk-Kalina, University of Warsaw) — Principal investigator
First posted
Mar 14, 2023
Start date
May 2023 (estimated)
Primary completion
May 2023 (estimated)
Completion
Sep 2023 (estimated)
Last update
Mar 21, 2023

Study contacts

Aleksandra Juszczyk-Kalina, Msc
Contact
a.juszczyk@uw.edu.pl
22 554 97 05 ext. +48
Aleksandra Juszczyk-Kalina, Msc
principal investigator · University of Warsaw

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.

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