Online CBT Intervention for Students With Adjustment Disorder (Online CBT)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Adjustment Disorders
• Intervention / Treatment: Behavioral: Internet CBT-UP intervention iCBT-UP; Behavioral: Internet Progressive Muscle Realxation Training (iPMR)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 216
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Aleksandra Juszczyk-Kalina, Msc; Phone Number: +48 22 554 97 05; Email: a.juszczyk@uw.edu.pl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; 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.
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); 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.
No Intervention: Waiting List; Participants from the waiting list condition will receive access to the choosen intervention after 6-weeks waiting period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Change in Depression	The patient health questionnaire-9 (PHQ-9)	measured at baseline, immediately after the interventions and 1 month follow up
Change in General Anxiety Disorder	General Anxiety Disorder-7 (GAD-7)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Stress	Scale of experienced stress (PSS-10)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Satisfaction with life	Satisfaction with life scale (SWLS)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Academic Adjustment	Academic adjustment scale (AAS)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Experiential Avoidance	Acceptance and Action Questionnaire	measured at baseline, immediately after the interventions and 1 month follow up
Change in Cognitive Fusion	Cognitive Fusion Questionnaire (CFQ)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Self-compassion	Self Compassion Scale - Short Form (SCS-SF)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Mindfulness	Five Facet Mindfulness Questionnaire (FFMQ-15)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Persevative thinking	Perseverative Thinking Questionnaire (PTQ)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Mental well-being	Warwick-Edinburgh Mental Well-being Scale (WEMWBS)	measured at baseline, immediately after the interventions and 1 month follow up
Change in Cognitive functioning	Stroop Task (color-word)	measured at baseline, immediately after the interventions and 1 month follow up
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Warsaw
• Investigators: Principal Investigator: Aleksandra Juszczyk-Kalina, Msc, University of Warsaw

Study record dates

Study Major Dates

• Study Start (Anticipated): May 1, 2023
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: February 13, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 14, 2023

Study Record Updates

• Last Update Posted (Actual): March 21, 2023
• Last Update Submitted That Met QC Criteria: March 16, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: students; cognitive behavioural therapy; adjustment disorder; internet psychological interventions
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Trauma and Stressor Related Disorders; Disease; Adjustment Disorders
• Other Study ID Numbers: 08/01/2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No