Group-based Stabilization and Skill Training for Patients With Lasting Posttraumatic Reactions in Mental Health Care

NCT03887559 — Not applicable, Active not recruiting, 160 participants, St. Olavs Hospital

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Adding a Group Based Stabilization and Skill Training Intervention for Patients With Long Lasting Posttraumatic Reactions Receiving Outpatient Treatment in Specialized Mental Health Care - A Randomized Controlled Trial

RegistryNCT03887559
StatusActive not recruiting
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment160 (Estimated)
SponsorSt. Olavs Hospital (Other); collaborators: Norwegian University of Science and Technology
ConditionsStress Disorders, Post-Traumatic, Mental Disorders, Trauma and Stressor Related Disorders
InterventionsGroup-based stabilization and skill training in addition to individual treatment, Treatment as usual (Behavioral, other)
Datesstart 2019-03-25, primary completion 2027-08-01 (estimated), completion 2028-12-01 (estimated), first posted 2019-03-25, last updated 2026-10-21
Locations1 site in Norway

Related Papers Related Patents Related Grants Related Experts
All trials for Stress Disorders, Post-Traumatic All trials for Mental Disorders All trials of Group-based stabilization and skill training in addition to individual treatment All trials of Treatment as usual

-Summary

This study evaluates the addition of a group based stabilization and skill-training intervention to individual out-patient treatment for long lasting post-traumatic reactions. Half of the participants will receive the combined treatment while the other half will receive individual treatment as usual.

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+Detailed description

Many patients in mental health care have previously experienced life-stressors and traumatic events that are related to the problems they seek treatment for. Although the diagnostic labels vary, the clinical picture often demonstrates long lasting complex psychological and somatic post-traumatic symptoms such as avoidance, bodily activation, difficulties in regulating emotions and in relationships with others, impaired quality of life and reduced level of function. Patients often receive long-term individual therapy in general mental health care, occasionally without clinically significant improvement. Still, they continue treatment due to high symptom pressure and low level of functioning. The study targets a novel intervention which tests the effect of adding a group based stabilization and skill training intervention to conventional individual treatment among 160 patients already receiving treatment in a community mental health hospital. Change in variables covering mental health issues, functional impairment, well-being, use of hospital services and drug prescriptions will be examined, as well as markers of inflammation found in sera before and after intervention. The purpose is to develop better and more effective treatment options for a large number of patients who receive mental health care in community mental health hospitals.

+Arms and interventions

ArmTypeInterventionsDescription
Intervention groupExperimentalBehavioral: Group-based stabilization and skill training in addition to individual treatmentGroup-based stabilization and skill-training combined with individual treatment.
controlsActive comparatorOther: Treatment as usualIndividual treatment as usual only.
  • Group-based stabilization and skill training in addition to individual treatment (Behavioral): Group-based stabilization and skill training, weekly 2-hour sessions during 20 weeks. Based on the manual "Tilbake til Nåtid" ("Back to here and now") (Holbæk, 2014) developed by clinicians in the highly specialized national trauma clinic 'Modum Bad's Trauma Clinic'.
  • Treatment as usual (Other): Treatment as usual: conventional individual treatment (outpatient). Not standardized.

+Outcome measures

Primary outcomes

  • Questionnaire about Process of Recovery' (QPR) Change from baseline [4 weeks after intervention group has completed group treatment]: Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
  • Questionnaire about Process of Recovery' (QPR) Change from baseline [6 months after intervention group has completed group treatment]: Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)
  • Questionnaire about Process of Recovery' (QPR) Change from baseline [12 months after intervention group has completed group treatment]: Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

Secondary outcomes

  • The Work and Social Adjustment Scale (WSAS) change from baseline [4 weeks, 6 months and 12 months after intervention group has completed group treatment]: Functional impairment associated with mental Health measured by self-report
  • The International Trauma Questionnaire (ITQ) change from baseline [4 weeks, 6 months and 12 months after intervention group has completed group treatment]: Self-report to capture elements of post-traumatic stress disorder (PTSD) and complex post-traumatic stress disorder (CPTSD)
  • The Clinical Outcome in Routine Evaluation (CORE-10) change from baseline [4 weeks, 6 months and 12 months after intervention group has completed group treatment]: Sel-report measure of psychological distress, capturing general mental health issues.
  • WHO Five Well-Being Index (WHO-5) change from baseline [4 weeks, 6 months and 12 months after intervention group has completed group treatment]: Questionnaire assessing subjective psychological well-being and also a measure of depression.
  • Posttraumatic Cognition Inventory (PTCI-9) change from baseline [4 weeks, 6 months and 12 months after intervention group has completed group treatment]: Self-report measure of negative and dysfunctional posttraumatic cognitions

Other outcomes

  • Use of health services in hospitals - Data extracted from The National Patient Register (NPR)- change from baseline [12 months after group intervention]: The National Patient Register (NPR) regularly receives data from all health authorities in Norway on treatment episodes in hospitals and mental health services. Data extracted will include type of clinical unit, time of admission, length of stay in inpatient units, consultations in outpatient units and mobile teams and diagnoses, measured 12 months before group intervention and 12 months after group intervention.
  • Prescriptions of medicine -Data extracted from The Norwegian Prescription Database - change from baseline [12 months after group intervention]: The Norwegian Prescription Database regularly receives data on prescriptions on drug prescriptions from doctors in primary and secondary health care services and hospitals. Extracted data will cover prescriptions, 12 months before group intervention and 12 months after group intervention.
  • Occupational status- Data extracted from The Norwegian Labour and Welfare Administration (NAV)- change from baseline [12 months after group intervention]: The Norwegian Labour and Welfare Administration (NAV) have data on all citizens working status and sick-leaves lasting for more than two weeks. Extracted data will include information such as sick- and disability leaves 12 months before group intervention and 12 months after group intervention.

+Eligibility

Sex: All, ages: 18 Years to 75 Years

Inclusion Criteria:

* Receiving treatment in ordinary out-patient clinics
* Having been exposed to or witnessing to traumatic event(s) defined as "one or several extremely threatening or horrific events or series of events or situations being of such a character which is likely to overwhelming distress in almost anyone in a similar situation", measured by Stressful Life Events Screening Questionnaire
* Presenting with posttraumatic reactions such as hyperarousal, avoidance, intrusions, emotional dysregulation or interpersonal difficulties.
* Symptom duration for a minimum of six months.
* Understand and speak Norwegian to an extent that is required to participate in a stabilization- and skill-training group.

Exclusion Criteria:

* Active psychotic symptoms.
* Substance or drug addiction or abuse.
* High suicidal risk considered by the individual therapist.
* Having participated in the course previously.

+Locations (1)

FacilityCityCountryStatus
Department of Tiller DPS, St. Olavs Hospital University Hospital in TrondheimTrondheimNorway

+Publications

  • Results publication: Holgersen KH, Bronstad I, Jensen M, Brattland H, Reitan SK, Hassel AM, Arentz M, Lara-Cabrera M, Skjervold AE. A combined individual and group-based stabilization and skill training intervention versus treatment as usual for patients with long lasting posttraumatic reactions receiving outpatient treatment in specialized mental health care - a study protocol for a randomized controlled trial. Trials. 2020 May 27;21(1):432. doi: 10.1186/s13063-020-04297-z. PMID 32460840

+Investigators

  • Anne-Lise Løvaas, Study director, St. Olavs Hospital