Clinical trial NCT05768308: Online CBT Intervention for Students With Adjustment Disorder
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
Overall status: UNKNOWN
Phase: NA
Conditions: Adjustment Disorders
Keywords: adjustment disorder
students
internet psychological interventions
cognitive behavioural therapy
Lead sponsor: University of Warsaw
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Adjustment disorder
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
Secondary outcomes:
measure: Change in Depression
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in General Anxiety Disorder
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Stress
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Satisfaction with life
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Academic Adjustment
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Experiential Avoidance
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Cognitive Fusion
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Self-compassion
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Mindfulness
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Persevative thinking
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Mental well-being
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Cognitive functioning
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Academic performance
timeFrame: measured at baseline, immediately after the interventions and 1 month follow up
measure: Change in Daily Depressogenic adjustment
timeFrame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
measure: Change in Daily negative thinking
timeFrame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
measure: Change in Emotional regulation
timeFrame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
measure: Change in Self-compassion
timeFrame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
measure: Change in Daily-affect
timeFrame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
measure: Change in Procrastination
timeFrame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
Other outcomes:
Locations:
Study officials:
affiliation: University of Warsaw
name: Aleksandra Juszczyk-Kalina, Msc
role: PRINCIPAL_INVESTIGATOR
References: