Online CBT Intervention for Students With Adjustment Disorder

NCT ID: NCT05768308

Last Updated: 2023-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-31

Study Completion Date

2023-09-30

Brief Summary

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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

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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.

Conditions

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Adjustment Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet CBT-UP intervention (iCBT-UP)

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

Group Type EXPERIMENTAL

Internet CBT-UP intervention iCBT-UP

Intervention Type BEHAVIORAL

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.

Internet Progressive Muscle Realxation Training (iPMR)

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

Group Type ACTIVE_COMPARATOR

Internet Progressive Muscle Realxation Training (iPMR)

Intervention Type BEHAVIORAL

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.

Waiting List

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Internet 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.

Intervention Type BEHAVIORAL

Internet 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Warsaw

OTHER

Sponsor Role lead

Responsible Party

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Aleksandra Juszczyk

Msc Aleksandra Juszczyk-Kalina

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aleksandra Juszczyk-Kalina, Msc

Role: PRINCIPAL_INVESTIGATOR

University of Warsaw

Central Contacts

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Aleksandra Juszczyk-Kalina, Msc

Role: CONTACT

22 554 97 05 ext. +48

References

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Juszczyk-Kalina A, Holas P, Farchione TJ. Effectiveness and mediators of change of an online CBT intervention for students with adjustment disorder-study protocol for a randomized controlled trial. Trials. 2023 Dec 1;24(1):777. doi: 10.1186/s13063-023-07744-9.

Reference Type DERIVED
PMID: 38041148 (View on PubMed)

Other Identifiers

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08/01/2023

Identifier Type: -

Identifier Source: org_study_id

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