Skip to content

Online CBT Intervention for Students With Adjustment Disorder

Effectiveness and Mediators of Change of an Online CBT Intervention for Students With Adjustment Disorder - Study Protocol for a Randomized Controlled Trial

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05768308
Acronym
Online CBT
Enrollment
216
Registered
2023-03-14
Start date
2023-05-31
Completion date
2023-09-30
Last updated
2023-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adjustment Disorders

Keywords

adjustment disorder, students, internet psychological interventions, cognitive behavioural therapy

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.

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.

Sponsors

University of Warsaw
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Adjustment disordermeasured at baseline, immediately after the interventions and 1 month follow upAdjustment disorder - The Adjustment Disorder New Module 20 (ADNM-20)

Secondary

MeasureTime frameDescription
Change in General Anxiety Disordermeasured at baseline, immediately after the interventions and 1 month follow upGeneral Anxiety Disorder-7 (GAD-7)
Change in Stressmeasured at baseline, immediately after the interventions and 1 month follow upScale of experienced stress (PSS-10)
Change in Satisfaction with lifemeasured at baseline, immediately after the interventions and 1 month follow upSatisfaction with life scale (SWLS)
Change in Academic Adjustmentmeasured at baseline, immediately after the interventions and 1 month follow upAcademic adjustment scale (AAS)
Change in Experiential Avoidancemeasured at baseline, immediately after the interventions and 1 month follow upAcceptance and Action Questionnaire
Change in Cognitive Fusionmeasured at baseline, immediately after the interventions and 1 month follow upCognitive Fusion Questionnaire (CFQ)
Change in Self-compassionmeasured at baseline, immediately after the interventions and 1 month follow upSelf Compassion Scale - Short Form (SCS-SF)
Change in Mindfulnessmeasured at baseline, immediately after the interventions and 1 month follow upFive Facet Mindfulness Questionnaire (FFMQ-15)
Change in Depressionmeasured at baseline, immediately after the interventions and 1 month follow upThe patient health questionnaire-9 (PHQ-9)
Change in Mental well-beingmeasured at baseline, immediately after the interventions and 1 month follow upWarwick-Edinburgh Mental Well-being Scale (WEMWBS)
Change in Cognitive functioningmeasured at baseline, immediately after the interventions and 1 month follow upStroop Task (color-word)
Change in Academic performancemeasured at baseline, immediately after the interventions and 1 month follow upThis index will be based on a three recently received grades. The mean will be assessed.
Change in Daily Depressogenic adjustment7 days during the first week of the intervention and 7 days during the sixth week of the intervention timeMeasured in daily diaries. It will be measured by three items based on Becks triad.
Change in Daily negative thinking7 days during the first week of the intervention and 7 days during the sixth week of the intervention timeMeasured in daily diaries. Rumination and worrying. Daily worry measures will be measured with three items taken from Meyer et al. (1990).
Change in Emotional regulation7 days during the first week of the intervention and 7 days during the sixth week of the intervention timeMeasured 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 Daily-affect7 days during the first week of the intervention and 7 days during the sixth week of the intervention timeMeasured in daily diaries, based on circumplex model.
Change in Procrastination7 days during the first week of the intervention and 7 days during the sixth week of the intervention timeMeasured in daily diaries, by three items from The Pure Procrastination scale.
Change in Persevative thinkingmeasured at baseline, immediately after the interventions and 1 month follow upPerseverative Thinking Questionnaire (PTQ)

Contacts

Primary ContactAleksandra Juszczyk-Kalina, Msc
a.juszczyk@uw.edu.pl22 554 97 05

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026