Online CBT Intervention for Students With Adjustment Disorder

NCT05768308 | Unknown

• 1 other identifier: 08/01/2023
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Adjustment Disorders

Keywords

adjustment disorder; students; internet psychological interventions; cognitive behavioural therapy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (19)

• Change in Depression

  measured at baseline, immediately after the interventions and 1 month follow up

• Change in General Anxiety Disorder

  measured at baseline, immediately after the interventions and 1 month follow up

• Change in Stress

  measured at baseline, immediately after the interventions and 1 month follow up

• Change in Satisfaction with life

  measured at baseline, immediately after the interventions and 1 month follow up

• Change in Academic Adjustment

  measured at baseline, immediately after the interventions and 1 month follow up

Study Arms (3)

Internet CBT-UP intervention (iCBT-UP)

EXPERIMENTAL

Patricipants in the experimental group will receive online cbt intervention for students with adjustment disorder (iCBT-UP).

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).

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.

Interventions

Internet CBT-UP intervention iCBT-UP BEHAVIORAL

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 CBT-UP intervention (iCBT-UP)

Internet Progressive Muscle Realxation Training (iPMR) BEHAVIORAL

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.

Internet Progressive Muscle Realxation Training (iPMR)

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• having a student status
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Warsaw: lead

Related Publications (1)

• 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.

  PMID: 38041148 DERIVED

MeSH Terms

Conditions

Adjustment Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Aleksandra Juszczyk-Kalina, Msc

  University of Warsaw

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aleksandra Juszczyk-Kalina, Msc

CONTACT

22 554 97 05; a.juszczyk@uw.edu.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Msc Aleksandra Juszczyk-Kalina

Study Record Dates

• First Submitted: February 13, 2023
• First Posted: March 14, 2023
• Study Start: May 1, 2023
• Primary Completion: May 1, 2023
• Study Completion: September 1, 2023
• Last Updated: March 21, 2023

Record last verified: 2023-03