Mindfulness-based boxing therapy to treat depression and anxiety

Not Applicable

Completed

• Conditions: Major depressive disorder (MDD) and generalized anxiety disorder (GAD); Mental and Behavioural Disorders

• Registration Number: ISRCTN23023309
• Lead Sponsor: Centre for Addiction and Mental Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2023-01-13
• Study Start: 2024-02-12
• Last Update Posted: 27 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Patients are included if they:
1. Are outpatients
2. Are voluntary and competent to consent to treatment
3. Have a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM–5) diagnosis of non-psychotic MDD, single or recurrent, or GAD
4. Are male or female between the ages of 18 - 40 years
5. Are able to adhere to the study schedule
6. Are currently taking psychiatric medication for at least 4 months – but are not planning on initiating a new treatment regimen during the pilot study

Exclusion Criteria

Patients are excluded if they:
1. Meet DSM-5 substance use disorder criteria within the past 3 months
2. Have a concomitant major unstable medical illness
3. Are pregnant or intend to get pregnant during the study (confirmed verbally)
4. Have a SCID-5 diagnosis of any psychotic disorder, bipolar disorder, obsessive-compulsive disorder, or post-traumatic stress disorder (current or within the last year)
5. Have a DSM-5 diagnosis of borderline personality disorder or previous documented borderline personality disorder (BPD) traits
6. Prior history of violence or sexual aggression

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The feasibility and acceptability of MBBT:<br>1. Recruitment assessed by measuring the number of eligible participants who consent to enroll in the study over a period<br>2. Retention assessed by tracking the percentage of participants who continue to engage with the study from start to finish<br>3. Adherence assessed by evaluating the consistency with which participants attend MBBT sessions<br>4. Acceptability assessed quantitatively by utilizing the Client Satisfaction Questionnaire (CSQ) and assessed qualitatively by informal interviews and utilizing an end User-Experience Questionnaire at the end of the study

Secondary Outcome Measures

Name	Time	Method
Measurement-Based Care Scales completed at baseline, midway (week 5), and upon completion (week 10):<br>1. Current depression level, measured using The 9-item Patient Health Questionnaire (PHQ-9) <br>2. Current anxiety level, measured using the Generalized Anxiety Disorder-7 (GAD-7) <br>3. Current psychological distress level, measured using the Kessler Psychological Distress Scale (K10)<br>4. Overall symptom level severity, measured using the Clinical Global Impression of Severity (CGI-S)<br>5. Current mindfulness level, measured using using The Mindful Attention and Awareness Scale (MAAS)<br> <br>There will also be an exploratory aim to measure the State Mindfulness Scale for Physical Activity (SMS-PA) of session 5 and the last session. Given that this is an exercise intervention, the researchers were also interested in exploring any changes in Body Mass Index (BMI) and qualitative changes related to fitness by measuring BMI at baseline, midway, and upon completion.