Physical Activity in the Management of Personality Disorders

NCT07341438 | Recruiting

• 1 other identifier: H-25047904
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Avoidant Personality Disorders; Borderline Personality Disorder (BPD)

Keywords

Physical activity; karate; walking; pedometer; martial arts; psychiatry; personality disorders; borderline personality disorder; avoidant personality disorder; feasibility; rct; randomized controlled trial; exercise

Outcome Measures

Primary Outcomes (7)

• Referral rate (initial interest rate)

  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.

  Assessed continuously throughout the recruitment period.

• Screening rate

  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.

  Assessed continuously throughout the recruitment period, prior to each participant's baseline assessment.

• Recruitment rate (consent rate)

  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.

  Assessed continuously throughout the recruitment period.

• Retention rate

  The proportion of participants who remain in the trial until completion. Calculation: Number of participants completing the study/Number of participants initially enrolled.

  From each participant's baseline assessment (week 0) to their 12-week follow-up.

• Adherence

  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.

  Assessed during the 8-week intervention period for each participant.

• Safety (Adverse Events)

  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.

  Weeks 0-8 for the intervention period for each participant; medical record review extend through 12-week follow-up.

• Reasons for non-participation or drop-out

  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).

  Collected throughout recruitment and study participation for each individual (from invitation to 12-week follow-up).

Secondary Outcomes (13)

• Simple Physical Activity Questionnaire (SIMPAQ)

  Baseline and 8-weeks follow-up.

• Exercise Addiction Inventory (EAI)

  Baseline, 8 weeks, and 12 weeks follow-up.

• Body composition

  Baseline and at 8-weeks follow-up.

• Personality Disorder Severity Scale - ICD 11 (PDS ICD 11)

  Baseline, 8 weeks, and 12 weeks follow up.

• Inventory of Interpersonal Problems - 32 items (IIP 32)

  Baseline, 8 weeks, and 12 weeks follow up.

Study Arms (3)

Treatment as usual

ACTIVE COMPARATOR

Participants in this arm receive treatment as usual and function as the control group.

Other: Treatment as usual (TAU)

Karate

EXPERIMENTAL

Participants receive supervised karate training twice a week for 8 weeks from experienced instructors.

Behavioral: Karate; Other: Treatment as usual (TAU)

Walking

EXPERIMENTAL

Participants follow an 8-week pedometer-based walking program with individually tailored goals.

Behavioral: Pedometer-based walking; Other: Treatment as usual (TAU)

Interventions

Karate BEHAVIORAL

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.

Karate

Treatment as usual (TAU) OTHER

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.

Karate; Treatment as usual; Walking

Pedometer-based walking BEHAVIORAL

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.

Walking

Eligibility Criteria

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

You may qualify if:

• adults (≥18 years)
• documented diagnosis of borderline personality disorder (BPD; F60.3, ICD-10) or avoidant personality disorder (AVPD; F60.6, ICD-10), as confirmed in the patient's medical record.
• at the time of recruitment, participants must be receiving treatment at one of two specialized psychotherapeutic outpatient clinics (Clinic A or Clinic B) in the Capital Region of Denmark
• proficient in Danish.

You may not qualify if:

• Individuals with a documented diagnosis of antisocial personality disorder (F60.2)

Sponsors & Collaborators

• Julie Midtgaard: lead
• Danish Council for Independent Research: collaborator
• Helsefonden, Denmark: collaborator

Study Sites (2)

Mental Health Center Stolpegård, Copenhagen University Hospital -Mental Health Services CPH, Copenhagen Denmark

Gentofte Municipality, Capital Region, 2820, Denmark

RECRUITING

Mental Health Centre Glostrup, Copenhagen University Hospital - Amager and Hvidovre, Denmark

Glostrup Municipality, Capital Region, 2620, Denmark

RECRUITING

Related Publications (1)

• Petersen J, Palic S, Nyboe L, Schuster M, Videbech P, Midtgaard J. Physical activity in the management of borderline personality disorder: A scoping review. Psychiatry Res. 2025 Aug;350:116535. doi: 10.1016/j.psychres.2025.116535. Epub 2025 May 5.

  PMID: 40398190 BACKGROUND

MeSH Terms

Conditions

Borderline Personality Disorder; Personality Disorders; Motor Activity

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mental Disorders; Behavior

Study Officials

• Julie Midtgaard, Professor

  Copenhagen University Hospital - Amager and Hvidovre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Justina Petersen, PhD student

CONTACT

+45 24278751; justina.petersen@regionh.dk

Ida Lundager Kraaer

CONTACT

+45 20379035; ida.lundager.kraaer@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 12, 2025
• First Posted: January 14, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)