Physical Activity in the Management of Personality Disorders

Condition(s) studied

Investigational drug(s) / intervention(s)

Karate: The karate group will be offered an 8-week, group-based Shotokan Karate-Do program with two 1-hour sessions per week, delivered at a local karate club. Sessions will be led by two experienced instructors who has recieved lectures in relevant personality pathology and treatment principles. The instructors will plan and adapt the training, which includes meditation to promote focus and calm, Kihon (basic techniques) to practice fundamental movements, Kumite (partnered exercises) to develop coordination, collaboration, and controlled sparring skills, and stretching to support recovery and flexibility. Exercises will be tailored individually to participants' needs, addressing both physical and cognitive aspects of training. Participants will receive relevant equipment, such as a karate uniform and participants may continue attending classes after the 8-week intervention until the end of the study.

Pedometer-based walking: The pedometer-based walking group include a pedometer (Garmin VivoFit 4) and a walking diary, inspired by NICE guidance (PH41). Materials will be reviewed with each participant to ensure understanding and support individual goal-setting. Goals will be tailored to each participant, aiming either to gradually increase daily PA or to establish a structured and manageable activity routine, depending on individual needs and preferences. The diary encourages daily step recording and reflection on physical activity habits. Throughout the 8-week intervention, participants will receive regular check-ins by phone or online at weeks 2, 4, and 6 to review progress, provide structured feedback, and adjust goals as needed.

Treatment as usual (TAU): Treatment as usual comprise treatment as usual within the psychiatric services. Participants are engaged in ongoing psychotherapeutic treatment when referred to the PANDA study, which includes group and/or individual therapy. As part of the group allocation information, they will be informed about the official Danish physical activity guidelines. Participants will be encouraged to continue their usual daily activities without any specific guidance toward or restriction from engaging in other interventions.

Study summary

The PANDA trial is studying whether two types of physical activity - a walking program and supervised karate training - are safe, acceptable, and possible for adults with certain personality disorders. The goal is to see if these activities can help people while being safe and easy to do.

Who can take part:

* Adults with borderline personality disorder or avoidant/anxious personality disorder.
* People receiving treatment at two outpatient mental health clinics in the Capital Region of Denmark.
* The study plans to include about 60 participants.

What will happen in the study:

Participants are randomly assigned to one of three groups:

* Usual treatment only (control group).
* Usual treatment plus walking program: an 8 - week pedometer - based program with goal setting and follow-up sessions.
* Usual treatment plus supervised karate training: an 8 - week program led by experienced instructors.

What the study will look at:

* Main goal: Check if the programs can be done as planned, including whether participants attend sessions, follow the program, and stay safe.
* Other outcomes: Possible changes in physical health, fitness, emotions, personality symptoms, body image, and daily activity.
* Data will be collected through physical tests, questionnaires, and follow-up interviews about participants' experiences and motivation.
* Measurements will take place at the start, after 8 weeks, and after 12 weeks (follow-up questionnaires only).

Why this study is important:

The results will help researchers decide if it is possible to run a larger study in the future to see if walking or karate training can improve health and wellbeing for people with personality disorders.

Eligibility

Primary outcome measure(s)

• Referral rate (initial interest rate) — Assessed continuously throughout the recruitment period.
  The proportion of patients approached by clinical staff who agree to be referred to the research team for further information about the study. Calculation: Number of patients referred to the research team/Number of patients approached by clinical staff.
• Screening rate — Assessed continuously throughout the recruitment period, prior to each participant's baseline assessment.
  The proportion of participants referred by clinical staff who complete the research team's information session. Calculation: Number of participants attending the information session/Number of participants referred by clinical staff.
• Recruitment rate (consent rate) — Assessed continuously throughout the recruitment period.
  The proportion of participants who consent to join the trial after attending the research team's information session. Calculation: Number of participants providing informed consent/Number of participants attending the information session.
• Retention rate — From each participant's baseline assessment (week 0) to their 12-week follow-up.
  The proportion of participants who remain in the trial until completion. Calculation: Number of participants completing the study/Number of participants initially enrolled.
• Adherence — Assessed during the 8-week intervention period for each participant.
  The extent to which participants comply with their assigned intervention. Individual criteria: Karate group: Attendance at ≥8 of 16 sessions (≥50%). Walking group: Achievement of individually defined weekly step goals in ≥6 of 8 weeks (≈70%). Progression criterion: Progression to a full-scale RCT without modification requires that at least 70% of participants in each intervention arm meet these adherence criteria.
• Safety (Adverse Events) — Weeks 0-8 for the intervention period for each participant; medical record review extend through 12-week follow-up.
  Occurrence of any adverse events (AEs) during the intervention period. Assessment: Bi-weekly self-reported electronic questionnaires via REDCap. Extraction from medical records for events such as emergency department visits.
• Reasons for non-participation or drop-out — Collected throughout recruitment and study participation for each individual (from invitation to 12-week follow-up).
  Documented explanations provided voluntarily by participants who decline participation or discontinue the trial. Assessment: Categorized according to predefined options (e.g., intervention not attractive, inconvenient timing, travel distance, lack of energy, other).

Trial sites (2)