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Adjustment DisorderNCT07128017

Online MBCT for Adjustment Disorder During COVID-19: Efficacy, Mechanisms, and RCT

A study testing Mindfulness-Based Cognitive Therapy (Internet-delivered) and Progressive Muscle Relaxation (Internet-delivered) in people with Adjustment Disorder and Anxiety, run by University of Warsaw at 1 site in Poland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This study tested a 4-week, internet-based Mindfulness-Based Cognitive Therapy (MBCT) program designed to help people experiencing adjustment disorder during the COVID-19 pandemic. Adjustment disorder is a stress-related condition that can cause anxiety, depression, and difficulty coping after major life changes. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adjustment Disorder, Anxiety, Depressive
What is being tested?
Mindfulness-Based Cognitive Therapy (Internet-delivered) and Progressive Muscle Relaxation (Internet-delivered)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
301 participants
Where
1 sitePoland
Study dates
25 May 2020to 21 Aug 2020
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants are required to be (a) at least 18 years old, (b) have access to the Internet, (c) currently experiencing some form of psychological distress related to COVID-19 pandemic, such as stress, anxiety, and/or low mood, and d) have the willingness to commit to a free online intervention program with two pre and post measurements online, within four weeks.

Who cannot join

  • participating simultaneously in any pharmaceutical or psychosocial therapy, (b) if they were suffering from a current or lifetime psychotic disorder, bipolar disorder, or substance abuse problem; (c) if they reported current suicidal tendencies, (d) if they did not meet criteria for Adjustment Disorder (less than 47,5 points in ADNM-20 questionnaire), (e) participated in the past or currently in any of 8 weeks mindfulness programs (e.g., MBSR, MBCT).

Trial locations and contacts

1 site in 1 country.

Poland1 site
  • Faculty of Psychology, University of Warsaw

    Warsaw, 00-927

Other trials in Poland

About this study

Official title: Efficacy and Mechanisms of Internet-delivered MBCT for Adjustment Disorder During the COVID-19 Pandemic: A Randomized Controlled Trial

This study tested a 4-week, internet-based Mindfulness-Based Cognitive Therapy (MBCT) program designed to help people experiencing adjustment disorder during the COVID-19 pandemic. Adjustment disorder is a stress-related condition that can cause anxiety, depression, and difficulty coping after major life changes.

We compared the online MBCT program to two other groups: an internet-based relaxation training program and a wait-list group. A total of 301 adults from Poland took part. We measured symptoms of adjustment disorder, depression, and anxiety before the program, right after, and one month later.

Read more

Results showed that the online MBCT program led to greater improvements in depression and anxiety than the other two groups. People in MBCT also developed more self-compassion and were better able to distance themselves from unhelpful thoughts, which helped reduce their symptoms. Benefits lasted at least one month after the program ended.

These findings suggest that a brief, self-guided, online mindfulness program can be an effective, accessible way to support mental health during stressful times such as a pandemic.

Read the detailed description

Background and Rationale Adjustment disorder (AjD) is a stress-related mental health condition characterized by maladaptive emotional and behavioral responses to an identifiable stressor. Core symptoms include persistent preoccupation with the stressor and difficulty adapting, often accompanied by anxiety, depressed mood, and avoidance behaviors. According to ICD-11 criteria, AjD symptoms emerge within three months of a stressor and typically resolve within six months after the stressor ends, although in many cases they can persist longer and contribute to chronic distress.

Epidemiological studies indicate that AjD is highly prevalent, affecting up to 30% of clinical populations and a substantial proportion of the general public during times of widespread stress. Despite this, AjD remains understudied compared to mood and anxiety disorders. Few empirically validated psychological interventions are available, and existing treatment recommendations are often extrapolated from evidence on depression and anxiety.

The COVID-19 pandemic presented a unique context in which AjD rates surged globally. Fear of infection, prolonged social isolation, economic uncertainty, and disruption of daily life contributed to high levels of stress-related distress. Surveys during the pandemic indicated that 18-43% of adults in Europe reported symptom patterns consistent with AjD, underscoring the urgent need for scalable interventions that could be delivered remotely and at low cost.

Mindfulness-Based Cognitive Therapy (MBCT) MBCT is an eight-week, group-based psychological program originally developed to prevent relapse in recurrent depression. It combines mindfulness meditation practices with cognitive-behavioral therapy strategies, fostering non-judgmental awareness of present-moment experience, greater cognitive flexibility, and reduced reactivity to negative thoughts and emotions.

Mechanistic research suggests that MBCT works by:

Increasing cognitive defusion - the ability to step back from and observe thoughts without automatically believing or reacting to them.

Reducing experiential avoidance - the tendency to suppress or avoid difficult emotions and sensations.

Enhancing self-compassion - a kinder, more understanding stance toward oneself in times of suffering.

These processes are relevant to AjD, where stressor-related rumination and self-critical coping often maintain distress. Although MBCT's efficacy for depression and anxiety is well-established, little is known about its effects in AjD or its feasibility in brief, fully online, self-guided formats.

Internet-Delivered MBCT (iMBCT) Internet-delivered psychological interventions (IPIs) have the potential to greatly expand access to evidence-based care. Online MBCT (iMBCT) can be delivered synchronously (live sessions with a facilitator) or asynchronously (self-paced, unguided), with evidence supporting effectiveness in reducing distress and improving resilience. Unguided iMBCT programs are especially promising for public health implementation due to their low delivery cost and scalability, but high-quality trials in specific clinical groups remain rare.

Study Objectives

The primary aim of this study was to evaluate the efficacy of a four-week, unguided, internet-delivered MBCT program for adults meeting ICD-11 criteria for AjD during the COVID-19 pandemic. We compared iMBCT with:

An active control - a four-week, unguided internet-delivered Progressive Muscle Relaxation (iPMR) program.

A passive control - a wait-list control (WLC).

Secondary aims were to examine whether changes in key psychological processes (cognitive fusion, experiential avoidance, self-compassion) mediated symptom improvement, providing insight into the mechanisms through which iMBCT exerts its effects.

Methods Overview This was a three-arm, parallel-group randomized controlled trial. A total of 301 adults from Poland who met ICD-11 AjD criteria (based on the Adjustment Disorder New Module - 20) were randomized to iMBCT, iPMR, or WLC. Interventions lasted four weeks, with assessments at baseline, post-intervention, and one-month follow-up (for intervention groups).

Interventions

iMBCT: A self-guided adaptation of MBCT condensed to six modules over 30 days. Modules included audio-guided mindfulness meditations (body scan, sitting meditation, mindful movement), reflective journaling, and psychoeducational materials. Content was delivered through a secure online platform with automated email reminders.

iPMR: A self-guided Progressive Muscle Relaxation program based on the Bernstein and Borkovec protocol, progressing from tensing and releasing 16 muscle groups to relaxation through mental recall. Audio instructions and written materials were provided.

WLC: No intervention during the 4-week study period. Participants were offered a choice of iMBCT or iPMR afterward.

Outcomes and Process Measures

Primary outcomes:

AjD symptoms (ADNM-20)

Depressive symptoms (PHQ-9)

Anxiety symptoms (GAD-7)

Process measures:

Cognitive Fusion (CFQ)

Experiential Avoidance (AAQ-II)

Self-Compassion (SCS-SF)

Key Findings

All groups showed significant symptom reductions over time, but iMBCT participants had greater improvements in depression and anxiety than both iPMR and WLC.

AjD remission rates were highest in the iMBCT group.

Cognitive defusion fully mediated the effect of iMBCT on depression and anxiety, suggesting it is a key mechanism of change.

Increases in self-compassion were observed only in the iMBCT group compared to WLC.

Benefits in the intervention groups were maintained at one-month follow-up.

Significance and Implications This trial provides the first randomized evidence that a brief, unguided iMBCT program can effectively reduce symptoms of AjD, depression, and anxiety, and improve transdiagnostic processes associated with resilience. Its low cost, scalability, and sustained benefits make it a promising tool for addressing stress-related disorders in situations where traditional face-to-face therapy is unavailable or impractical, such as during large-scale public health crises.

The findings also add to the mechanistic literature on MBCT, highlighting cognitive defusion as a central pathway to symptom improvement in AjD. This may inform refinements in mindfulness-based interventions and encourage further research on tailoring MBCT to specific stressor-related conditions.

Future research should test longer-term outcomes, evaluate implementation in diverse cultural contexts, and explore the integration of brief guidance or peer support to reduce attrition.

Being tested
Mindfulness-Based Cognitive Therapy (Internet-delivered), Progressive Muscle Relaxation (Internet-delivered), No Intervention - Waitlist Control
Keywords
Adjustment Disorder, Mindfulness-Based Cognitive Therapy, MBCT, Internet-delivered intervention, Online mental health, Cognitive defusion, Self-compassion, Experiential avoidance, Progressive Muscle Relaxatio, COVID-19 pandemic, Stress-related disorders, Depression, Anxiety, Randomized controlled trial, Unguided self-help interventio
Medical subject headings
Adjustment Disorders, Anxiety Disorders, COVID-19, Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mindfulness-Based Cognitive Therapy (Internet-delivered)Behavioural

    Also called iMBCT

    A 4-week (30 days), unguided online adaptation of the Mindfulness-Based Cognitive Therapy (MBCT) program. The intervention consisted of six sequential modules delivered through a secure web platform, including guided mindfulness meditations, body scan, mindful movement, and cognitive-behavioral exercises. Participants received audio recordings, written materials, and reflective tasks, along with automated reminder emails. No therapist guidance was provided.

  • Progressive Muscle Relaxation (Internet-delivered)Behavioural

    Also called iPMR

    A 4-week, unguided online progressive muscle relaxation (PMR) program adapted from Bernstein and Borkovec's protocol. The program included six sequential modules teaching systematic tensing and relaxing of major muscle groups, gradually reducing the number of groups until relaxation could be achieved through recall alone. Materials included audio recordings, written instructions, and automated reminder emails. No therapist guidance was provided.

  • No Intervention - Waitlist ControlBehavioural

    Participants in this arm received no active intervention during the 4-week waitlist period but completed all study assessments on the same schedule as intervention arms. After the waiting period, participants were offered the choice to take part in either the online MBCT or PMR program.

Study groups in NCT07128017
Study groupRoleWhat they receive
Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)ExperimentalInternet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT) Participants received a 4-week, unguided online adaptation of Mindfulness-Based Cognitive Therapy. The program consisted of six sequential modules delivered via a secure web platform, introducing mindfulness meditation, body scan, mindful movement, and cognitive-behavioral exercises. Content was provided through audio recordings, written materials, and reflective exercises. Supportive reminder emails were sent, but no therapist guidance was given.
Receives: Behavioral: Mindfulness-Based Cognitive Therapy (Internet-delivered)
Internet-Delivered Progressive Muscle Relaxation (iPMR)Active comparatorParticipants received a 4-week, unguided online progressive muscle relaxation program adapted from Bernstein and Borkovec's protocol. The program consisted of six sequential modules teaching systematic tensing and releasing of major muscle groups, gradually reducing the number of groups over time until relaxation could be achieved through recall alone. Audio guidance, written instructions, and reminder emails were provided without therapist involvement.
Receives: Behavioral: Progressive Muscle Relaxation (Internet-delivered)
Waitlist Control (WLC)Placebo comparatorParticipants were placed on a 4-week waitlist without active intervention. They completed all study assessments on the same schedule as intervention arms. At the end of the waiting period, they were offered the choice to participate in either the iMBCT or iPMR program.
Receives: Behavioral: No Intervention - Waitlist Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Adjustment Disorder symptoms

    Change in Adjustment Disorder symptoms from baseline to post-intervention, measured by the Adjustment Disorder New Module - 20 (ADNM-20).

    The ADNM-20 is a validated self-report questionnaire assessing ICD-11 Adjustment Disorder symptoms, including preoccupation and failure to adapt. Scores range from 0 to 60, with higher scores indicating greater symptom severity.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

  2. Remission Rates from Adjustment Disorder

    Instrument: Adjustment Disorder New Module - 20 (ADNM-20) Proportion of participants scoring below the clinical cutoff (>47.5) on the ADNM-20 at post-intervention, indicating remission from probable Adjustment Disorder.

    Measured: Baseline (Week 0) and Post-intervention (Week 4)

Secondary outcomes (5)
  1. Change in Depressive Symptoms

    Patient Health Questionnaire-9 (PHQ-9). Description: The PHQ-9 is a validated self-report measure assessing the severity of depressive symptoms. Scores range from 0 to 27, with higher scores indicating greater severity.

    Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8)

  2. Change in Anxiety Symptoms

    Instrument: Generalized Anxiety Disorder Scale-7 (GAD-7) The GAD-7 is a validated self-report measure of generalized anxiety symptoms. Scores range from 0 to 21, with higher scores indicating greater severity.

    Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8)

  3. Change in Cognitive Fusion

    Instrument: Cognitive Fusion Questionnaire (CFQ). The CFQ assesses the extent to which individuals are entangled with their thoughts. Scores range from 7 to 49, with higher scores indicating greater cognitive fusion.

    Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8)

  4. Change in Self-Compassion

    Instrument: Self-Compassion Scale - Short Form (SCS-SF). Description: The SCS-SF measures self-compassion across six subdomains. Scores range from 12 to 60, with higher scores indicating greater self-compassion.

    Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8)

  5. Change in Experiential Avoidance

    Instrument: Acceptance and Action Questionnaire - II (AAQ-II). The AAQ-II measures experiential avoidance (the tendency to avoid unpleasant thoughts and feelings). Scores range from 7 to 49, with higher scores indicating greater avoidance.

    Measured: Baseline (Week 0), Post-intervention (Week 4), Follow-up (Week 8)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Aug 2025
  2. Study start25 May 2020
  3. Primary completion21 Jul 2020
  4. Study completion21 Aug 2020

Resources

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
Model description
his study used a three-arm, parallel-group randomized controlled trial design. Participants meeting ICD-11 criteria for Adjustment Disorder were randomly assigned to one of three conditions: (1) unguided internet-delivered Mindfulness-Based Cognitive Therapy (iMBCT), (2) internet-delivered Progressive Muscle Relaxation (iPMR) as an active control, or (3) a waitlist control (WLC). Randomization was stratified by demographic characteristics and baseline symptom severity to ensure balanced groups.
Masking
None (open label)
Enrolment
301 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07128017
Sponsor's protocol ID
UWarsaw1
Status last verified
Aug 2025
First submitted
15 Aug 2025
Last updated
17 Aug 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: At this time, it has not been determined whether individual participant data (IPD) will be shared. The decision will depend on considerations such as participant privacy, applicable legal and ethical requirements, and the availability of resources to prepare de-identified datasets.

Questions about this trial

What is this clinical trial studying?

A study testing Mindfulness-Based Cognitive Therapy (Internet-delivered) and Progressive Muscle Relaxation (Internet-delivered) in people with Adjustment Disorder and Anxiety, run by University of Warsaw at 1 site in Poland.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 17 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Adjustment Disorder symptoms (time frame: Baseline (Week 0) and Post-intervention (Week 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 17 Aug 2025.

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