Self Help Plus for Asylum Seekers and Refugees in Europe

NCT03571347 | Completed DMC

• 1 other identifier: 779255
• Study Type: interventional
• Target: 459
• Locations: 1 country
• Sites: 1

Brief Summary

Background The flow of asylum seekers and refugees moving to European and bordering countries has progressively increased in the last years. This population is exposed to physical and mental challenges before and during displacement, and suffer continuing hardships after arrival in a High-Income Country. As a consequence, asylum seekers and refugees are extremely vulnerable to some common mental health conditions, i.e., post-traumatic stress disorder, anxiety, depression and other forms of disabling psychological distress. The World Health Organization has developed a new 5-session self-help intervention called Self-Help Plus (SH+) for managing stress and coping with adversity. SH+ has been evaluated in RCTs in low- and middle-income countries, however, there is no rigorous evidence on its cost-effectiveness in preventing the onset of mental disorders in HIC. Objectives To evaluate the effectiveness and cost-effectiveness of the SH+ in asylum seekers and refugees with psychological distress resettled in six sites of five European countries (Italy, Austria, Germany, Finland, and two sites in the UK), as compared with enhanced treatment as usual (ETAU). The primary outcome is the reduction in the incidence of any mental disorders. Secondary outcomes are mental health symptoms, psychological functioning, well-being, drop-out rates, and economic outcomes. Design This is a multicentre parallel-group randomized controlled trial, in which participants will have an equal probability (1:1) of being randomly allocated to the SH+ or the ETAU. Methodology Asylum seekers and refugees who screen positive at the General Health Questionnaire (≥ 3) and without a formal diagnosis of any psychiatric disorders according to the M.I.N.I. International Neuropsychiatric Interview will enter the study. After random allocation they will receive the SH+ or the ETAU. Assessments will be performed by masked assessors immediately after intervention, at 6 months, and a 12 months after randomization. Time frame The recruitment phase will last 12 months. After the screening, eligible participants will be assessed at baseline, post-intervention, and at 6- and 12-month follow-up. The SH+ delivery will be conducted in around 5 weeks. Expected outcomes A reduction in the incidence of psychiatric diagnoses at 6-month follow-up, and a general improvement in mental health symptoms, psychological functioning, well-being, and economic outcomes at each assessment.

Conditions

Stress, Psychological

Keywords

distress; post-traumatic stress disorder; prevention; asylum seekers; refugees; Self Help Plus; Europe

Outcome Measures

Primary Outcomes (1)

• Psychiatric diagnosis at 6-month follow-up

  The primary outcome will be the number of participants with a current psychiatric diagnosis 6 at six-month follow-up, as measured by the M.I.N.I.

  6-month follow-up

Secondary Outcomes (10)

• Psychological distress

  Post-intervention; 6-month and 12-month follow-ups

• Psychiatric diagnosis

  Post-intervention; 6-month and 12-month follow-ups

• Functioning

  Post-intervention; 6-month and 12-month follow-ups

• Depressive symptoms

  Post-intervention; 6-month and 12-month follow-ups

• Subjective wellbeing

  Post-intervention; 6-month and 12-month follow-ups

Study Arms (2)

Self Help Plus

EXPERIMENTAL

SH+ programme has been developed by WHO and collaborators working in the humanitarian field, with expertise in global mental health and psychosocial interventions. SH+ programme consists of a pre-recorded audio course, complemented with bibliotherapy, and thanks to this format not requiring much time from experts for implementation. SH+ consists of 5 sessions.

Behavioral: Self Help Plus

Enhanced Treatment As Usual

OTHER

Control arm participants will receive routine social support and/or care according to ordinary practice and following local regulations. Additionally, they will receive baseline and follow-up assessments according to the study schedule, and information about freely available mental health services, social services and community networks providing support to asylum seekers and refugees, and NGOs' contact details.

Other: Enhanced Treatment As Usual

Interventions

Self Help Plus BEHAVIORAL

5-session psychosocial intervention

Self Help Plus

Enhanced Treatment As Usual OTHER

Routine social support and/or care, and information about freely available mental health services, social services, NGOs, and community networks providing support to asylum seekers and refugees

Enhanced Treatment As Usual

Eligibility Criteria

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

You may qualify if:

• Age 18 or above;
• Able to speak and understand the target languages: Arabic, and/or Urdu, and/or Dari, and/or English;
• Asylum seeker or refugee;
• Presence of psychological distress, as shown by a score of 3 or more at the 12 item General Health Questionnaire (GHQ-12 ≥ 3);
• Both oral and written informed consent to enter the study.

You may not qualify if:

• Presence of any mental disorders according to DSM-V and ICD-10, as shown by a positive M.I.N.I.;
• Acute medical conditions contraindicating study participation, based on clinical judgment of the health care professional with a clinical background who performs the screening;
• Clinical evidence of imminent suicide risk or suicide risk scored as "moderate or high" (or a positive suicidality behaviour disorder) by the M.I.N.I. (section SUICIDALITY);
• Clinical evidence that the decision-making capacity is impaired.

Sponsors & Collaborators

• Universita di Verona: lead
• World Health Organization: collaborator
• VU University of Amsterdam: collaborator
• University of Vienna: collaborator
• University of Ulm: collaborator
• The International Federation of Red Cross and Red Crescent Societies: collaborator
• University of Turku: collaborator
• University of Liverpool: collaborator
• University of York: collaborator

Study Sites (1)

Università di Verona

Verona, VR, 37134, Italy

Location

Related Publications (1)

• Purgato M, Carswell K, Acarturk C, Au T, Akbai S, Anttila M, Baumgartner J, Bailey D, Biondi M, Bird M, Churchill R, Eskici S, Hansen LJ, Heron P, Ilkkursun Z, Kilian R, Koesters M, Lantta T, Nose M, Ostuzzi G, Papola D, Popa M, Sijbrandij M, Tarsitani L, Tedeschi F, Turrini G, Uygun E, Valimaki MA, Wancata J, White R, Zanini E, Cuijpers P, Barbui C, Van Ommeren M. Effectiveness and cost-effectiveness of Self-Help Plus (SH+) for preventing mental disorders in refugees and asylum seekers in Europe and Turkey: study protocols for two randomised controlled trials. BMJ Open. 2019 May 14;9(5):e030259. doi: 10.1136/bmjopen-2019-030259.

  PMID: 31092670 DERIVED

MeSH Terms

Conditions

Stress, Psychological; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants, facilitators, and research staff involved in the screening and baseline assessment will not be blind to the interventions provided during the trial. Outcomes assessors will be kept blind to the study conditions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD, Clinical researcher

Model Details: RE-DEFINE is a prospective, multicentre, randomized, parallel-group trial that will follow study participants over a period of 12-months. Asylum seekers and refugees with psychological distress, but without a mental disorder according to the MINI International Neuropsychiatric Interview (M.I.N.I.) for DSM-V and ICD-10, will be randomly assigned to the Self Help Plus intervention or to enhanced treatment as usual (ETAU).

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 27, 2018
• Study Start: September 1, 2018
• Primary Completion: June 30, 2020
• Study Completion: December 31, 2020
• Last Updated: November 7, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)