Adjustment DisordersOnline CBTNCT05768308
Online CBT Intervention for Students With Adjustment Disorder
A study testing Internet CBT-UP intervention iCBT-UP and Internet Progressive Muscle Realxation Training (iPMR) in people with Adjustment Disorders, run by University of Warsaw.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Adjustment Disorders
- What is being tested?
- Internet CBT-UP intervention iCBT-UP and Internet Progressive Muscle Realxation Training (iPMR)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- No sites listed yet
- Study dates
- May 2023to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Adjustment Disorders
- Being tested
- Internet CBT-UP intervention iCBT-UP, Internet Progressive Muscle Realxation Training (iPMR)
- Keywords
- adjustment disorder, students, internet psychological interventions, cognitive behavioural therapy
- Medical subject headings
- Adjustment Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet CBT-UP intervention iCBT-UPBehavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Internet CBT-UP intervention (iCBT-UP) | Experimental | Patricipants in the experimental group will receive online cbt intervention for students with adjustment disorder (iCBT-UP). Receives: Behavioral: Internet CBT-UP intervention iCBT-UP |
| Internet Progressive Muscle Realxation Training (iPMR) | Active comparator | Participants from the active control group will receive progressive muscle relaxation training (iPMR). Receives: Behavioral: Internet Progressive Muscle Realxation Training (iPMR) |
| Waiting List | No intervention | Participants from the waiting list condition will receive access to the choosen intervention after 6-weeks waiting period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Adjustment disorder
Adjustment disorder - The Adjustment Disorder New Module 20 (ADNM-20)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Secondary outcomes (19)
Change in Depression
The patient health questionnaire-9 (PHQ-9)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in General Anxiety Disorder
General Anxiety Disorder-7 (GAD-7)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in Stress
Scale of experienced stress (PSS-10)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in Satisfaction with life
Satisfaction with life scale (SWLS)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in Academic Adjustment
Academic adjustment scale (AAS)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in Experiential Avoidance
Acceptance and Action Questionnaire
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in Cognitive Fusion
Cognitive Fusion Questionnaire (CFQ)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in Self-compassion
Self Compassion Scale - Short Form (SCS-SF)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in Mindfulness
Five Facet Mindfulness Questionnaire (FFMQ-15)
Measured: measured at baseline, immediately after the interventions and 1 month follow up
Change in Persevative thinking
Perseverative Thinking Questionnaire (PTQ)
Measured: 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: measured at baseline, immediately after the interventions and 1 month follow up
Change in Cognitive functioning
Stroop Task (color-word)
Measured: 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: 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.
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 7 days during the first week of the intervention and 7 days during the sixth week of the intervention time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study startMay 2023 (estimated)
- Primary completionMay 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adjustment DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandra Juszczyk, University of Warsaw
- Investigators
- Aleksandra Juszczyk-Kalina, Msc, Principal investigator, University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768308
- Sponsor's protocol ID
- 08/01/2023
- Acronym
- Online CBT
- Status last verified
- Mar 2023
- First submitted
- 13 Feb 2023
- Last updated
- 21 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Juszczyk-Kalina A, Holas P, Farchione TJ. Effectiveness and mediators of change of an online CBT intervention for students with adjustment disorder-study protocol for a randomized controlled trial. Trials. 2023 Dec 1;24(1):777. doi: 10.1186/s13063-023-07744-9.
PubMed 38041148
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Mediators of Change of an Online CBT Intervention for Students With Adjustment Disorder - Study Protocol for a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05768308
- Acronym / sponsor ID
- Online CBT / 08/01/2023
- Conditions
- Adjustment Disorders
- Keywords
- adjustment disorder, students, internet psychological interventions, cognitive behavioural therapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 216 participants (estimated)
- Lead sponsor
- University of WarsawUniversity, hospital or other
- Study start
- May 2023 (estimated)
- Primary completion
- May 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 14 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Internet CBT-UP intervention (iCBT-UP) | Experimental | Behavioral: Internet CBT-UP intervention iCBT-UPPatricipants in the experimental group will receive online cbt intervention for students with adjustment disorder (iCBT-UP). |
| Internet Progressive Muscle Realxation Training (iPMR) | Active comparator | Behavioral: Internet Progressive Muscle Realxation Training (iPMR)Participants from the active control group will receive progressive muscle relaxation training (iPMR). |
| Waiting List | No intervention | –Participants from the waiting list condition will receive access to the choosen intervention after 6-weeks waiting period. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet CBT-UP intervention iCBT-UPThe 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. | Behavioural | Internet CBT-UP intervention (iCBT-UP) |
| 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. | Behavioural | Internet Progressive Muscle Realxation Training (iPMR) |
Primary outcome
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)
19 secondary outcomes
Change in Depression
Time frame: 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
Change in Stress
Time frame: 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
Change in Academic Adjustment
Time frame: 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
Change in Cognitive Fusion
Time frame: 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
Change in Mindfulness
Time frame: 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
Change in Mental well-being
Time frame: 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
Change in Academic performance
Time frame: 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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2023.
- Derived from this study: PubMed 38041148Juszczyk-Kalina A, Holas P, Farchione TJ. Effectiveness and mediators of change of an online CBT intervention for students with adjustment disorder-study protocol for a randomized controlled trial. Trials. 2023 Dec 1;24(1):777. doi: 10.1186/s13063-023-07744-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aleksandra Juszczyk-Kalina, Msc principal investigator
University of Warsaw
Questions about this trial
What is this clinical trial studying?
A study testing Internet CBT-UP intervention iCBT-UP and Internet Progressive Muscle Realxation Training (iPMR) in people with Adjustment Disorders, run by University of Warsaw.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aleksandra Juszczyk-Kalina, Msc (22 554 97 05 ext. +48, a.juszczyk@uw.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Adjustment disorder (time frame: measured at baseline, immediately after the interventions and 1 month follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05768308, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2023.