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

NCT07128017 | Completed

• 1 other identifier: UWarsaw1
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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.

Conditions

Adjustment Disorder; Anxiety; Depressive

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

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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.

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

Secondary Outcomes (5)

• Change in Depressive Symptoms

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

• Change in Anxiety Symptoms

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

• Change in Cognitive Fusion

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

• Change in Self-Compassion

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

• Change in Experiential Avoidance

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

Study Arms (3)

Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)

EXPERIMENTAL

Internet-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.

Behavioral: Mindfulness-Based Cognitive Therapy (Internet-delivered)

Internet-Delivered Progressive Muscle Relaxation (iPMR)

ACTIVE COMPARATOR

Participants 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.

Behavioral: Progressive Muscle Relaxation (Internet-delivered)

Waitlist Control (WLC)

PLACEBO COMPARATOR

Participants 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.

Behavioral: No Intervention - Waitlist Control

Interventions

Mindfulness-Based Cognitive Therapy (Internet-delivered) BEHAVIORAL

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.

Also known as: iMBCT

Internet-Delivered Mindfulness-Based Cognitive Therapy (iMBCT)

Progressive Muscle Relaxation (Internet-delivered) BEHAVIORAL

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.

Also known as: iPMR

Internet-Delivered Progressive Muscle Relaxation (iPMR)

No Intervention - Waitlist Control BEHAVIORAL

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.

Waitlist Control (WLC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• (a) 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).

Sponsors & Collaborators

• University of Warsaw: lead

Study Sites (1)

Faculty of Psychology, University of Warsaw

Warsaw, 00-927, Poland

Location

MeSH Terms

Conditions

Adjustment Disorders; Anxiety Disorders; COVID-19; Depression

Interventions

Mindfulness-Based Cognitive Therapy; Autogenic Training

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Mindfulness; Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Hypnosis; Mind-Body Therapies; Complementary Therapies; Therapeutics

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: MD, PhD

Model Details: 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.

Study Record Dates

• First Submitted: August 15, 2025
• First Posted: August 17, 2025
• Study Start: May 25, 2020
• Primary Completion: July 21, 2020
• Study Completion: August 21, 2020
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

PL (1)