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

March 16, 2023 updated by: Aleksandra Juszczyk, University of Warsaw

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
216

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Adjustment disorder
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Self-compassion
Time Frame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
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
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
The patient health questionnaire-9 (PHQ-9)
measured at baseline, immediately after the interventions and 1 month follow up
Change in General Anxiety Disorder
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
General Anxiety Disorder-7 (GAD-7)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Stress
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Scale of experienced stress (PSS-10)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Satisfaction with life
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Satisfaction with life scale (SWLS)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Academic Adjustment
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Academic adjustment scale (AAS)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Experiential Avoidance
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Acceptance and Action Questionnaire
measured at baseline, immediately after the interventions and 1 month follow up
Change in Cognitive Fusion
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Cognitive Fusion Questionnaire (CFQ)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Self-compassion
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Self Compassion Scale - Short Form (SCS-SF)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Mindfulness
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Five Facet Mindfulness Questionnaire (FFMQ-15)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Persevative thinking
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Perseverative Thinking Questionnaire (PTQ)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Mental well-being
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Cognitive functioning
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
Stroop Task (color-word)
measured at baseline, immediately after the interventions and 1 month follow up
Change in Academic performance
Time Frame: measured at baseline, immediately after the interventions and 1 month follow up
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
Time Frame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
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
Time Frame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
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
Time Frame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
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
Time Frame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
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
Time Frame: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Warsaw

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Aleksandra Juszczyk-Kalina, Msc, University of Warsaw

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 13, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 14, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 21, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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