Effects of a brief intervention on symptoms of posttraumatic stress among migrants with a refugee background
| ISRCTN | ISRCTN85818585 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85818585 |
| Sponsor | Mid Sweden University |
| Funder | Vetenskapsrådet |
- Submission date
- 14/03/2026
- Registration date
- 16/03/2026
- Last edited
- 16/03/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Due to exposure to traumatic life events before and during forced displacement, migrants with a refugee background experience elevated rates of posttraumatic stress disorder (PTSD). Upon arrival in the host country, they often continue to face multiple challenges related to resettlement and integration. At the same time, refugees encounter numerous barriers to accessing mental healthcare, leading to the underutilization of available services. In turn, untreated PTSD can have detrimental effects on successful integration into society.
The aim of this study is to evaluate whether a novel and brief intervention method, CoRe (Cognitive load during Reconsolidation of traumatic memories), can reduce symptoms of posttraumatic stress and whether changes in symptoms influence different domains of integration. CoRe has previously shown strong effects in reducing symptoms of PTSD and has now been translated and culturally adapted to meet the needs of some of the most common refugee-background groups residing in Sweden.
A further aim is to investigate whether symptom change is associated with change in different domains of integration.
Who can participate?
Adults aged 18–70 years who self-identify as having a refugee background (WHO definition) are eligible to participate in the study. Participants must speak, read, and understand Arabic, Dari, Farsi, English, or Swedish, report psychological distress related to adverse memories, and be able to generate mental images of autobiographical memories.
What does the study involve?
The intervention is delivered individually, online via video link and includes two meetings: an intervention session and a booster session one week later. The first meeting lasts approximately 90 minutes, and the second lasts approximately 30 minutes.
During the first session, a clinical psychologist will guide the participants and teach them a method for approaching and managing difficult memories. Participants will work with a memory from one of their difficult experiences. After the first meeting, participants will practice the method at home for about one week before attending the second session.
Participants in this study are randomly assigned to one of two groups: one group receives the intervention immediately, and the other group waits for five weeks before starting the intervention.
During the study, participants will also complete questionnaires about intrusive memories, posttraumatic stress symptoms, depression, and anxiety. The first and last questionnaires also include questions about experiences in different domains of integration, quality of life and resilience.
What are the possible benefits and risks of participating?
The intervention aims to help participants approach and manage distressing memories. Participants will also receive information about common psychological reactions following stressful experiences.
Thinking about difficult memories may feel uncomfortable, and symptoms may sometimes feel stronger during the process. This is common in therapy and is usually temporary, and it is not expected to be more distressing than the discomfort that can occur when difficult memories intrude in everyday life. However, no such indications have been observed in previous use of this method, but if participants experience a significant worsening of symptoms, they are encouraged to contact the research team or their regular healthcare provider.
Where is the study run from?
The study is conducted by researchers at Mid Sweden University in collaboration with colleagues at Linköping University.
When is the study starting and how long is it expected to run for?
Participants will be recruited to the study during 2026 and 2027.
Who is funding the study?
The research is funded by the Swedish Research Council
Who is the main contact?
Anna Bjärtå, Principal Investigator
Mid Sweden University
anna.bjarta@miun.se
Contact information
Scientific, Principal investigator, Public
Kunskapens väg 1
Östersund
83140
Sweden
 ORCID ID |
0000-0003-0011-7770 |
|---|---|
| Phone | +46 703270611 |
| anna.bjarta@miun.se |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Open (masking not used) |
| Control | Uncontrolled |
| Assignment | Parallel |
| Purpose | Treatment |
| Scientific title | Cognitive load during reconsolidation of traumatic memories: A randomized controlled trial evaluating a brief intervention versus waitlist controls for reducing posttraumatic stress symptoms among migrants with a refugee background residing in Sweden |
| Study acronym | CoRe |
| Study objectives | The primary objective is to evaluate the effect of a brief reconsolidation based intervention (CoRe), compared with a waitlist control condition, on the frequency and distress of intrusive memories and on global symptoms of posttraumatic stress disorder (PTSD). Statistically and clinically significant change will be evaluated for global PTSD symptoms. The primary endpoint is 5 weeks after randomization. Participants are also assessed 10 weeks after randomization in order to follow up on symptoms when the waitlist control group has received CoRe. Key secondary objectives include assessing long-term outcomes about 1 year after the intervention, including symptoms of PTSD, depression, anxiety, sleep problems, quality of life, and resilience, and examining the relationship between symptom change and different domains of integration (psychological, social, economic, political, linguistic, and navigational) |
| Ethics approval(s) |
Approved 12/01/2026, Swedish Ethical Review Authority (Box 2110, Uppsala, 75002, Sweden; +46104750800; registrator@etikprovning.se), ref: 2025-08360-01 |
| Health condition(s) or problem(s) studied | Traumaspectrum symptoms including symptoms of posttraumatic stress, depression, anxiety, and sleep problems, in migrants with refugee background. |
| Intervention | SCREENING, ELIGIBILITY, AND RANDOMIZATION The trial is embedded in a longitudinal research program following migrants with a refugee background during the resettlement process. The program includes four annual questionnaires assessing mental health, integration outcomes, and quality of life. Within this program, different types of support activities are provided, of which the CoRe intervention is one. Participants who meet the inclusion criteria are invited to participate in the CoRe study. The following procedure is then applied: 1. Online eligibility screening 2. Baseline assessment (also used as the baseline assessment for the longitudinal program) 3. Eligibility interview (confirmation of inclusion criteria and assessment of exclusion criteria) 4. Randomization Participants who are excluded from CoRe during the eligibility interview are offered alternative support activities within the program. Participants who meet all eligibility criteria are randomly assigned to one of two study arms: an intervention group receiving CoRe immediately, or a waitlist control group receiving the CoRe intervention after a waiting period of five weeks. Participants who initiate support activities other than CoRe during the study period (one year), will be excluded from analyses after the start of the additional support but they may continue participation in the longitudinal research program. A randomization list is generated using Sealed Envelope™, applying 1:1 allocation with block randomization using permuted blocks with randomly varying block sizes of 4, 6, and 8 participants. The randomization list is concealed through programmed logic in an Excel-based system, preventing access to upcoming allocations. The group assignment is revealed after final inclusion when the session leader (psychologist) enters the participant code. THE INTERVENTION Cognitive load during memory Reconsolidation (CoRe) is a brief psychological intervention targeting intrusive memory symptoms. It is delivered individually via encrypted video calls by a trained clinical psychologist. The intervention consists of two sessions. The first session lasts approximately 90 minutes and includes psychoeducation and guided practice of the method, during which the participant works with a self-selected distressing autobiographical memory. During this exercise, the therapist guides the participant’s attention toward non-emotional aspects of the memory, such as visual details, in order to tax visuospatial working memory resources through progressively more demanding tasks during memory reconsolidation. The second session takes place one week later, and serves as a booster session. It lasts approximately 30 minutes and includes a brief refresher of the intervention and a discussion of participants’ experiences of practicing the method between sessions. Participants are instructed to practice the method independently at home between sessions. Before the second session, participants complete a one-week monitoring measure reporting how often they practiced the method and current symptom levels. The method has been piloted in a Swedish sample (manuscript in preparation) and showed a strong decrease in the frequency of intrusive memories, as well as statistically and clinically significant reductions in global symptoms of PTSD. |
| Intervention type | Behavioural |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/12/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | All |
| Target sample size at registration | 80 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Age 18–70 years 2. Self identify as having a refugee background (WHO definition) 3. Ability to speak, read, and understand Arabic, Dari, Farsi, English, or Swedish 4. Psychological distress related to adverse memories, assessed by items measuring the frequency and distress of intrusive memories 5. Ability to visualize mental images |
| Key exclusion criteria | 1. High suicide risk requiring immediate clinical intervention or referral to specialized care 2. Severe psychiatric conditions requiring other treatment 3. Low intellectual or relational functioning preventing participation in the intervention 4. Current participation in psychological treatment |
| Date of first enrolment | 01/04/2026 |
| Date of final enrolment | 31/12/2027 |
Locations
Countries of recruitment
- Sweden
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
16/03/2026: Trial's existence confirmed by Swedish Ethical Review Authority.
