Online CBT Intervention for Students With Adjustment Disorder

Adjustment Disorders Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05768308
• Other study ID #: 08/01/2023
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 2023
• Est. completion date: September 2023

Study information

• Verified date: March 2023
• Source: University of Warsaw
• Contact: Aleksandra Juszczyk-Kalina, Msc
• Phone: 22 554 97 05
• Email: a.juszczyk[@]uw.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 216
• Est. completion date: September 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Adjustment Disorders
• Disease

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Warsaw

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Adjustment disorder	Adjustment disorder - The Adjustment Disorder New Module 20 (ADNM-20)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Depression	The patient health questionnaire-9 (PHQ-9)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in General Anxiety Disorder	General Anxiety Disorder-7 (GAD-7)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Stress	Scale of experienced stress (PSS-10)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Satisfaction with life	Satisfaction with life scale (SWLS)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Academic Adjustment	Academic adjustment scale (AAS)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Experiential Avoidance	Acceptance and Action Questionnaire	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Cognitive Fusion	Cognitive Fusion Questionnaire (CFQ)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Self-compassion	Self Compassion Scale - Short Form (SCS-SF)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Mindfulness	Five Facet Mindfulness Questionnaire (FFMQ-15)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Persevative thinking	Perseverative Thinking Questionnaire (PTQ)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Mental well-being	Warwick-Edinburgh Mental Well-being Scale (WEMWBS)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Cognitive functioning	Stroop Task (color-word)	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Academic performance	This index will be based on a three recently received grades. The mean will be assessed.	measured at baseline, immediately after the interventions and 1 month follow up
Secondary	Change in Daily Depressogenic adjustment	Measured in daily diaries. It will be measured by three items based on Becks triad.	7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
Secondary	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).	7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
Secondary	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).	7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
Secondary	Change in Self-compassion	Measured in daily diaries, by three items from Self Compassion Scale (SCS).	7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
Secondary	Change in Daily-affect	Measured in daily diaries, based on circumplex model.	7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
Secondary	Change in Procrastination	Measured in daily diaries, by three items from The Pure Procrastination scale.	7 days during the first week of the intervention and 7 days during the sixth week of the intervention time