NCT03887559

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Mar 2019Dec 2027

First Submitted

Initial submission to the registry

March 11, 2019

Completed
14 days until next milestone

First Posted

Study publicly available on registry

March 25, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

March 25, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

7.2 years

First QC Date

March 11, 2019

Last Update Submit

April 24, 2026

Conditions

Stress Disorders, Post-TraumaticMental DisordersTrauma and Stressor Related Disorders

Keywords

Psychotherapy

Outcome Measures

Primary Outcomes (3)

  • Questionnaire about Process of Recovery' (QPR) Change from baseline

    Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

    4 weeks after intervention group has completed group treatment

  • Questionnaire about Process of Recovery' (QPR) Change from baseline

    Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

    6 months after intervention group has completed group treatment

  • Questionnaire about Process of Recovery' (QPR) Change from baseline

    Experienced personal recovery is measured by self-report; 'Questionnaire about Process of Recovery' (QPR)

    12 months after intervention group has completed group treatment

Secondary Outcomes (5)

  • The Work and Social Adjustment Scale (WSAS) change from baseline

    4 weeks, 6 months and 12 months after intervention group has completed group treatment

  • The International Trauma Questionnaire (ITQ) change from baseline

    4 weeks, 6 months and 12 months after intervention group has completed group treatment

  • 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

  • WHO Five Well-Being Index (WHO-5) change from baseline

    4 weeks, 6 months and 12 months after intervention group has completed group treatment

  • Posttraumatic Cognition Inventory (PTCI-9) change from baseline

    4 weeks, 6 months and 12 months after intervention group has completed group treatment

Other Outcomes (3)

  • Use of health services in hospitals - Data extracted from The National Patient Register (NPR)- change from baseline

    12 months after group intervention

  • Prescriptions of medicine -Data extracted from The Norwegian Prescription Database - change from baseline

    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

Study Arms (2)

Intervention group

EXPERIMENTAL

Group-based stabilization and skill-training combined with individual treatment.

Behavioral: Group-based stabilization and skill training in addition to individual treatment

controls

ACTIVE COMPARATOR

Individual treatment as usual only.

Other: Treatment as usual

Interventions

Group-based stabilization and skill training in addition to individual treatmentBEHAVIORAL

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'.

Intervention group
Treatment as usualOTHER

Treatment as usual: conventional individual treatment (outpatient). Not standardized.

controls

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Tiller DPS, St. Olavs Hospital University Hospital in Trondheim

Trondheim, Norway

RECRUITING

Related Publications (1)

  • 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: 32460840DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticMental DisordersTrauma and Stressor Related Disorders

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic

Study Officials

  • Anne-Lise Løvaas

    St. Olavs Hospital

    STUDY DIRECTOR

Central Study Contacts

Katrine Høyer Holgersen, PhD

CONTACT

+47 72 82 39 00katrine.hoyer.holgersen@stolav.no

Heidi Brattland, PhD

CONTACT

+47 72 82 39 00heidi.brattland@stolav.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2019

First Posted

March 25, 2019

Study Start

March 25, 2019

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

April 30, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)