Pilot trial of an evidence-based low intensity psychosocial intervention delivered by lay therapists for asylum seekers and refugees

INTERVENTION: Participants will be randomised in the ratio 1:1:1 to one of three arms: Individual Problem Management Plus (PM+), Group Problem Management Plus (PM+) or no PM+ (control arm ‐ participants will receive usual care/peer support from voluntary organisation). Participants will be randomised using a secure (24‐hour) web‐based randomisation program controlled centrally by the Liverpool Clinical Trial Centre (LCTC). A personal login username and password, provided by the LCTC, will be required to access the randomisation system. Designated research staff will be issued with their personal login and password upon completion of training in the use of the system. The PM+ intervention consists of five weekly face‐to‐face sessions, delivered either one‐to‐one or in groups. The first session opens with psychoeducation, including information on common reactions to adversity, the rationale for PM+, goal setting, and brief motivational interviewing. Sessions one to four each introduce an intervention strategy: (i) Managing Stress (slow breathing exercise); (ii) Managing Problems (using problem‐solving techniques); (iii) Get Going, Keep Doing (applying behavioural activation techniques); and (iv) Strengthening Social Support. These strategies are applied by participants during the intervention session to problems they are facing. Each strategy is reviewed in subsequent sessions, with the application of strategies between sessions encouraged to enhance learning through repetition. The final session involves a revision of learning, education on preventing relapse, and ends with a culturally appropriate closing ceremony. Participants randomised to the control arm will not be offered any PM+ but will be able to access all usual care and peer support offered by the participating NGOs. To control for time and attention, participants randomised to the control arm will be invited to attend a local AS&R NGO of their choice. They are put in CONDITION: Mental health ; Mental and Behavioural Disorders PRIMARY OUTCOME: Severity of combined anxiety and depressive symptoms measured using Hospital Anxiety and Depression Scale (HADS) at 13 weeks post‐baseline SECONDARY OUTCOME: ; 1. Severity of combined anxiety and depressive symptoms measured using HADS.at 26 weeks post‐baseline; 2. Subjective wellbeing measured using WHO‐5 at 13‐ and 26‐weeks post‐baseline; 3. Functional impairment measured using WHODAS 2.0 at 13‐ and 26‐weeks post‐baseline; 4. Progress on problems for which participant has sought help, measured using PSYCHLOPS at 13‐ and 26‐weeks post‐baseline; 5. Post‐traumatic stress disorder measured using PCL‐5 at 13‐ and 26‐weeks post‐baseline; 6. Depressive disorder measured using PHQ‐9 at 13‐ and 26‐weeks post‐baseline; 7. Service and support use measured using CSRI at 13‐ and 26‐weeks post‐baseline; INCLUSION CRITERIA: 1. Asylum seekers and refugees 2. Age =18 years (self‐reported) 3. Score of =8 on either the depression or anxiety subscale of HADS and score of =17 on WHODAS 4. Good working knowledge of one or more of English, Farsi, Urdu and Arabic 5. Registered with a GP in Liverpool City Region 6. Willing to provide relevant socioeconomic data (age, medical information etc) 7. Provided written informed consent