{
  "abstract": "Objectives To pilot test a stepped care intervention and examine trial procedures in advance of a definitive randomised controlled trial (RCT). We aimed to evaluate safety, acceptability and adherence to interventions.DesignA two-arm, single-blind, parallel, pilot RCT.SettingMulticentre primary healthcare settings.Participants Adults with significant psychological distress (K10 (Kessler Psychological Distress Scale) score ≥20) were recruited in Jordan between September 2022 and February 2023.Interventions Participants were randomised to one of two arms. The intervention arm received a stepped care programme consisting of a guided self-help programme (Doing What Matters; DWM), followed by a more intensive group programme (group Problem Management Plus; gPM+). The control arm received a guided self-help programme alone. Both intervention arms also received Enhanced Treatment as Usual that comprised referral to available community support services.Primary and secondary outcome measures A mixed methods approach was used to examine trial procedures in preparation for a definitive RCT, evaluate safety, acceptability and adherence to interventions and examine the pattern of quantitative outcomes. The primary clinical outcome was assessor-reported depression and anxiety symptoms (Hopkins Symptom Checklist-25) at week 12.Results 145 distressed adults (meeting Kessler Distress Score-10 score of ≥20) were randomised to either the stepped care or the single intervention arm (86% female) on a 1:1 allocation basis. DWM was delivered over 5 weeks by trained non-specialist helpers, where participants attended on average 2.6 support calls. Those randomised to gPM+attended on average 3.3 sessions. The study demonstrated feasibility and acceptability for DWM and gPM+interventions as delivered by trained non-specialists. Although the trial was not powered to detect clinical effectiveness, the stepped care arm relative to the single intervention arm demonstrated significantly lower depression symptoms immediately after and at 3 months following intervention delivery. The study and trial procedures were acceptable to participants, non-specialists and programme staff and demonstrated feasibility of implementing such a framework in Jordan.Conclusions Findings from this trial informed a fully powered definitive RCT seeking to evaluate the clinical and cost-effectiveness of a stepped model of care in Jordan.Trial registration number ACTRN12621000189820p.",
  "authors": [
    {
      "affiliations": [
        "School of Psychology, University of New South Wales, Sydney, New South Wales, Australia"
      ],
      "name": "Dharani Keyan"
    },
    {
      "affiliations": [
        "Institute for Family Health, King Hussein Foundation, Amman, Jordan"
      ],
      "name": "Rand Habashneh"
    },
    {
      "affiliations": [
        "Institute for Family Health, King Hussein Foundation, Amman, Jordan"
      ],
      "name": "Hafsa El-Dardery"
    },
    {
      "affiliations": [
        "Institute for Family Health, King Hussein Foundation, Amman, Jordan"
      ],
      "name": "Muhannad Faroun"
    },
    {
      "affiliations": [
        "Institute for Family Health, King Hussein Foundation, Amman, Jordan"
      ],
      "name": "Feda’a Al-Johary"
    },
    {
      "affiliations": [
        "Institute for Family Health, King Hussein Foundation, Amman, Jordan"
      ],
      "name": "Adnan Abualhaija"
    },
    {
      "affiliations": [
        "Institute for Family Health, King Hussein Foundation, Amman, Jordan"
      ],
      "name": "Ibrahim Said Aqel"
    },
    {
      "affiliations": [
        "Department of Clinical Neuroscience, Division of Insurance Medicine, Karolinska Institutet, Stockholm, Sweden"
      ],
      "name": "Aemal Akhtar"
    },
    {
      "affiliations": [
        "Community Health Nursing Department, School of Nursing, The University of Jordan, Amman, Jordan"
      ],
      "name": "Latefa Ali Dardas"
    },
    {
      "affiliations": [
        "School of Psychology, University of New South Wales, Sydney, New South Wales, Australia"
      ],
      "name": "Richard A Bryant"
    }
  ],
  "title": "Stepped-care programme of brief psychological interventions for adults affected by adversity in Jordan: lessons from a pilot randomised controlled trial",
  "uid": "db738102-aa96-5301-b0c1-66f2857e53fd"
}