Self Help Plus for Asylum Seekers and Refugees in Europe (REDEFINE)

• ClinicalTrials.gov Identifier: NCT03571347
• Recruitment Status: Active, not recruiting
• First Posted: June 27, 2018
• Last Update Posted: August 20, 2020
• Sponsor: Universita di Verona
• Collaborators: World Health Organization; VU University of Amsterdam; University of Vienna; University of Ulm; The International Federation of Red Cross and Red Crescent Societies; University of Turku; University of Liverpool; University of York
• Information provided by (Responsible Party): Marianna Purgato, Universita di Verona

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Stress, Psychological	Behavioral: Self Help Plus; Other: Enhanced Treatment As Usual	Not Applicable

Detailed Description:

Asylum seekers and refugees will be randomized to receive the SH+ intervention or Enhanced Treatment as Usual. The SH+ has been developed by WHO and collaborators working in the humanitarian field, with expertise in global mental health and psychosocial interventions. SH+ consists of a pre-recorded audio course, delivered by facilitators in a group setting and complemented with an illustrated self-help book. SH+ was designed to be relevant for large adversity-affected populations: it is transdiagnostic, easily adaptable to different cultures and languages, and both meaningful and safe for people with and without mental disorders. The format of SH+ is innovative in that it seeks to ensure that key intervention components are delivered as intended without the burden of extensive facilitator training. SH+ programme is based on acceptance and commitment therapy (ACT), a form of cognitive-behavioral therapy, with distinct features. SH+ programme has two components: a pre-recorded course and an illustrated self-help book. Pre-recorded audio material (culturally adapted) is delivered across five 2-hour sessions to groups of up to 30 people. The audio material imparts key information about stress management and guides participants through individual exercises and small group discussions. To augment the audio recordings, an illustrated self-help book reviews all essential content and concepts 19. Written manuals help briefly-trained, non-specialist facilitators to conduct the course using the pre-recorded audio. The SH+ intervention will be delivered by briefly-trained, non-specialist facilitators.

The control intervention will receive Enhanced Treatment as Usual.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 459 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: 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).
• Masking: Single (Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Prevention
• Official Title: Refugee Emergency: DEFining and Implementing Novel Evidence-based Psychosocial Interventions
• Actual Study Start Date: September 1, 2018
• Actual Primary Completion Date: June 30, 2020
• Estimated Study Completion Date: December 30, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: Self Help Plus; 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; 5-session psychosocial intervention
Enhanced Treatment As Usual; 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; 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

Outcome Measures

Primary Outcome Measures :

1. Psychiatric diagnosis at 6-month follow-up [ Time Frame: 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.

Secondary Outcome Measures :

1. Psychological distress [ Time Frame: Post-intervention; 6-month and 12-month follow-ups ]
   Psychological distress will be measured through the General Health Questionnaire-12. The questionnaire asks whether the respondent has experienced a particular symptom or behaviour recently. Each item is rated on a four-point Likert scale (less than usual, no more than usual, rather more than usual, or much more than usual); and gives a total score of 36 or 12 based on the GHQ version and on the selected scoring methods.
2. Psychiatric diagnosis [ Time Frame: Post-intervention; 6-month and 12-month follow-ups ]
   Number of participants with a current psychiatric diagnosis as measured by the M.I.N.I.
3. Functioning [ Time Frame: Post-intervention; 6-month and 12-month follow-ups ]
   The WHO Disability Assessment Schedule 2.0 (WHODAS 2.0) is a generic assessment instrument assessing health and disability. It is used across all diseases, including mental, neurological and substance use disorders. It is simple to administer and applicable across cultures.
4. Depressive symptoms [ Time Frame: Post-intervention; 6-month and 12-month follow-ups ]
   Patient Health Questionnaire-9 (PHQ-9). The PHQ-9 is a 9-item instrument measuring the presence and severity of depression. Major depression is diagnosed if five or more of the nine depressive symptom criteria have been present at least "more than half the days" in the past two weeks, and one of the symptoms includes depressed mood or anhedonia.
5. Subjective wellbeing [ Time Frame: Post-intervention; 6-month and 12-month follow-ups ]
   WHO-5 Wellbeing index. The WHO-5 Wellbeing Index is a 5-item questionnaire measuring current psychological wellbeing and quality of life, rather than psychopathology.
6. Self-defined psychosocial goals [ Time Frame: Post-intervention; 6-month and 12-month follow-ups ]
   The Psychological Outcome Profiles instrument (PSYCHLOPS) consists of four questions. It contains three domains: problems (2 questions), function (1 question) and wellbeing (1 question).
7. Symptoms of Post traumatic stress disorder [ Time Frame: Post-intervention; 6-month and 12-month follow-ups ]
   PTSD Checklist for DSM-5 (PCL-5). The PCL-5 is a 20-item self-report measure that assesses the 20 DSM-5 symptoms of PTSD.
8. Health-related quality of life [ Time Frame: 6-month and 12-month follow-ups ]
   The EuroQol-5Dimension-3 level version (EQ-5D-3L). The EQ-5D-3L is applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status that can be used in the clinical and economic evaluation of health care as well as in population health surveys.
9. Cost-effectiveness [ Time Frame: 6-month and 12-month follow-ups ]
   The Client Service Receipt Inventory, European version (CSSRI-EU): Client sociodemographic and service receipt inventory (adapted version with other socio- demographic characteristics). The CSSRI is a research tool developed for collecting information that describes in detail the types and level of services that comprise the care package of each study member.
10. Proportion of participants leaving the study early [ Time Frame: This information will be collecfted at any time. ]
    Number of people leaving the study prematurely at any times, and reasons for discontinuation.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

1. Presence of any mental disorders according to DSM-V and ICD-10, as shown by a positive M.I.N.I.;
2. Acute medical conditions contraindicating study participation, based on clinical judgment of the health care professional with a clinical background who performs the screening;
3. 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);
4. Clinical evidence that the decision-making capacity is impaired.

Contacts and Locations

Locations

Italy

Università di Verona

Verona, VR, Italy, 37134

Sponsors and Collaborators

Universita di Verona

World Health Organization

VU University of Amsterdam

University of Vienna

University of Ulm

The International Federation of Red Cross and Red Crescent Societies

University of Turku

University of Liverpool

University of York

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Nosè M, Ostuzzi G, Papola D, Popa M, Sijbrandij M, Tarsitani L, Tedeschi F, Turrini G, Uygun E, Välimäki 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.

• Responsible Party: Marianna Purgato, Principal Investigator, PhD, Clinical researcher, Universita di Verona
• ClinicalTrials.gov Identifier: NCT03571347
• Other Study ID Numbers: 779255
• First Posted: June 27, 2018
• Last Update Posted: August 20, 2020
• Last Verified: August 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marianna Purgato, Universita di Verona:

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

Additional relevant MeSH terms:

Stress, Psychological; Behavioral Symptoms