The Effect of BAT Versus Mixed Physical Activity as add-on Treatment for Traumatised Refugees.

NCT01955538 | Completed Phase 3 DMC

• 1 other identifier: PTF4
• Study Type: interventional
• Target: 338
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomised controlled trial is to study two types of physical activities as add-on treatment, compared to treatment as usual for traumatised refugees. Hereby, the study will examine the evidence of an often-used treatment modality in a field where very little research yet has been conducted.

Conditions

PTSD; Depression; Pain

Outcome Measures

Primary Outcomes (1)

• Change in Harvard Trauma Questionnaire (HTQ)

  Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).

Secondary Outcomes (11)

• Change in Hopkins Symptom Check List (HSCL-25)

  Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).

• Change in Hamilton depression + anxiety (HAM D+A)

  Assessing a potential change between baseline at the beginning of the treatment and after 6 months (at the end of treatment).

• Change in World Health Organisation-5 (WHO5)

  Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).

• Change in Sheehan Disability Scale

  Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).

• Change in Visual Analogue Scale (VAS)

  Assessing a potential change between baseline at the beginning of treatment, after three months and after 6 months (at the end of treatment).

Study Arms (3)

Control

ACTIVE COMPARATOR

Psychiatric treatment as usual for 6 months according to best clinical practice: 10 consultations with a medical doctor (medication and psycho-education) as well as 16 consultations with a psychologist.

Other: Control; Other: Basic Body Awareness Therapy; Other: Mixed physical activity

Basic Body Awareness Therapy

EXPERIMENTAL

Standard psychiatric treatment + Basic Body Awareness Therapy for 20 weeks, 1 hour/week.

Other: Basic Body Awareness Therapy

Mixed physical activity

EXPERIMENTAL

Standard psychiatric treatment + Mixed physical activity for 20 weeks, 1 hour/week.

Other: Mixed physical activity

Interventions

Control OTHER

Psychiatric treatment as usual for 6 months according to best clinical practice.

Control

Basic Body Awareness Therapy OTHER

20 weeks, 1 hour/week.

Basic Body Awareness Therapy; Control

Mixed physical activity OTHER

20 weeks, 1 hour/week.

Control; Mixed physical activity

Eligibility Criteria

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

You may qualify if:

• Patients referred to treatment for PTSD at Competence Centre for Transcultural Psychiatry from September 2013 to May 2015.
• Adults (18 years or older)
• Refugees or persons who have been brought in under family reunification
• Symptoms of PTSD pursuant to the International Classification of Diseases (ICD-10) research criteria.
• Psychological trauma in the anamnesis. Trauma is typically imprisonment or detention with torture (according to the United Nations definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
• Assessed by a doctor to be motivated for treatment
• Informed consent.

You may not qualify if:

• Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F30.9). Patients are excluded only if the psychotic-like experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression.
• Current abuser of drugs and alcohol (F1x.24-F1x.26).
• In need of admission to psychiatric hospital.
• No informed consent.
• Physical handicaps that make the person unable to participate in the physical activity.
• Cardiac arrhythmia identified on the electrocardiogram taken before start of the treatment or symptoms of heart problems that are unclarified.

Sponsors & Collaborators

• Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital: lead
• TrygFonden, Denmark: collaborator

Study Sites (1)

Competence Centre for Transcultural Psychiatry, Psychiatric Centre Ballerup.

Copenhagen, Hellerup, 2900, Denmark

Location

Related Publications (4)

• Masmas TN, Moller E, Buhmann C, Bunch V, Jensen JH, Hansen TN, Jorgensen LM, Kjaer C, Mannstaedt M, Oxholm A, Skau J, Theilade LA, Worm L, Ekstrom M. [Health status and degree of traumatisation among newly arrived asylum seeker--secondary publication]. Ugeskr Laeger. 2010 Jan 11;172(2):120-4. Danish.

  PMID: 20376916 BACKGROUND

• Olsen DR, Montgomery E, Bojholm S, Foldspang A. Prevalence of pain in the head, back and feet in refugees previously exposed to torture: a ten-year follow-up study. Disabil Rehabil. 2007 Jan 30;29(2):163-71. doi: 10.1080/09638280600747645.

  PMID: 17364766 BACKGROUND

• Nordbrandt MS, Sonne C, Mortensen EL, Carlsson J. Trauma-affected refugees treated with basic body awareness therapy or mixed physical activity as augmentation to treatment as usual-A pragmatic randomised controlled trial. PLoS One. 2020 Mar 12;15(3):e0230300. doi: 10.1371/journal.pone.0230300. eCollection 2020.

  PMID: 32163509 DERIVED

• Nordbrandt MS, Carlsson J, Lindberg LG, Sandahl H, Mortensen EL. Treatment of traumatised refugees with basic body awareness therapy versus mixed physical activity as add-on treatment: Study protocol of a randomised controlled trial. Trials. 2015 Oct 22;16:477. doi: 10.1186/s13063-015-0974-9.

  PMID: 26492879 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression; Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maja Sticker Nordbrandt, MD

  Competence Centre for Transcultural Psychiatry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2013
• First Posted: October 7, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 29, 2016

Record last verified: 2016-04

Locations

DK (1)