Physical Activity in the Management of Personality Disorders: Protocol for a Three-Arm Randomized Feasibility Trial (The PANDA Trial)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 60
- Locations
- 2
- Primary Endpoint
- Referral rate (initial interest rate)
Study Overview
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.
Detailed Description
OBJECTIVE: The PANDA trial aims to examine the feasibility, acceptability and safety of two physical activity (PA) interventions - pedometer-based walking combined with treatment as usual and karate training combined with treatment as usual - compared to treatment as usual alone. The trial will also explore a range of secondary objective and subjective outcomes. The specific objectives are to:
- Assess feasibility for a future full-scale trial by measuring screening, recruitment, retention and attendance rates, and intervention safety.
- Describe changes in objective (body composition and physical fitness) and subjective (patient-reported measures of emotion regulation, personality disorder symptoms and severity, interpersonal functioning, personal recovery, PA behavior, body awareness, and body image) outcomes within and between groups, to estimate the standard deviation of each outcome to inform sample size calculations for a future definitive trial.
- Explore participant experiences using qualitative methods to assess acceptability and perceived impact of the interventions.
RECRUITMENT: Participants will be recruited from two psychotherapeutic clinics. Eligible patients will be identified during routine treatment by clinical staff based on predefined criteria. Staff will provide brief information about the trial and refer interested individuals to the research team. Additionally, potential participants may self-refer in response to posters in the two clinics. However, all self-referred patients must still meet the trial's inclusion criteria.
Detailed information about the study will then be provided in an information session, which can be conducted either in person or via telephone. Participants will have the option to be accompanied by a support person during this session. A minimum of 24 hours will be provided for reflection before scheduling the baseline visit. At the baseline visit, written informed consent will be obtained prior to any study assessments. Recruitment will continue until 60 participants are included or until July 1, 2026, whichever comes first. If fewer than 20 participants are recruited by April 1, 2026, the study will proceed as a non-randomized trial, allowing participants to select their preferred intervention arm.
STUDY VISITS: Participants will be assessed at three time points: baseline, 8 weeks, and 12 weeks. Baseline and 8-week assessments will be conducted in person, including completion of self-report questionnaires and physical measurements (body composition and cardiorespiratory fitness). The 12-week follow-up consists of questionnaires only and can be completed online at home via REDCap, with no in-person visit required.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •Individuals with a documented diagnosis of antisocial personality disorder (F60.2)
Arms & Interventions
Treatment as usual
Participants in this arm receive treatment as usual and function as the control group.
Intervention: Treatment as usual (TAU) (Other)
Karate
Participants receive supervised karate training twice a week for 8 weeks from experienced instructors.
Intervention: Karate (Behavioral)
Karate
Participants receive supervised karate training twice a week for 8 weeks from experienced instructors.
Intervention: Treatment as usual (TAU) (Other)
Walking
Participants follow an 8-week pedometer-based walking program with individually tailored goals.
Intervention: Pedometer-based walking (Behavioral)
Walking
Participants follow an 8-week pedometer-based walking program with individually tailored goals.
Intervention: Treatment as usual (TAU) (Other)
Outcomes
Primary Outcomes
Referral rate (initial interest rate)
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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
Time Frame: 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)
Time Frame: 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
Time Frame: 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).
Secondary Outcomes
- 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.)
- Questionnaire about the Process of Recovery (QPR)(Baseline, 8 weeks, and 12 weeks follow-up.)
- Difficulties in Emotion Regulation Scale - 16 items (DERS 16)(Baseline, 8 weeks, and 12 weeks follow-up.)
- Positive and Negative Affect (PANAS)(Baseline, 8 weeks, and 12 weeks follow-up.)
- BSL 23 Supplementary Items (from the Borderline Symptom list (BSL-23))(Baseline, 8 weeks, and 12 weeks follow-up.)
- The Body Appreciation Scale 2 (BAS-2)(Baseline, 8 weeks, and 12 weeks follow-up.)
- The Multidimensional Assessment of Interoceptive Awareness (MAIA) - Self-Regulation subscale(Baseline, 8 weeks, and 12 weeks follow-up.)
- Body Awareness Scale - Experience (BAS-E) (from the Body Awareness Scale - Movement Quality and Experience (BAS MQ E))(Baseline, 8 weeks, and 12 weeks follow-up.)
- Cardiorespiratory fitness (VO₂max)(Baseline and at 8-weeks follow-up)
Investigators
Julie Midtgaard
Professor
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital