Online CBT Intervention for Students With Adjustment Disorder

Study Overview
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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.

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

Conditions
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Adjustment Disorders

Intervention / Treatment
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* Behavioral: Internet CBT-UP intervention iCBT-UP
* Behavioral: Internet Progressive Muscle Realxation Training (iPMR)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet CBT-UP intervention (iCBT-UP)<br>Patricipants in the experimental group will receive online cbt intervention for students with adjustment disorder (iCBT-UP). | Behavioral: Internet CBT-UP intervention iCBT-UP<br>* 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.<br>|
| Active Comparator: Internet Progressive Muscle Realxation Training (iPMR)<br>Participants from the active control group will receive progressive muscle relaxation training (iPMR). | Behavioral: Internet Progressive Muscle Realxation Training (iPMR)<br>* 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.<br>|
| No Intervention: Waiting List<br>Participants from the waiting list condition will receive access to the choosen intervention after 6-weeks waiting period. | |

What is the study measuring?
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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 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 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 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adjustment disorder, students, internet psychological interventions, cognitive behavioural therapy