Low mood or mild depression Mental and Behavioural Disorders
Conditions
Interventions
This study is a two-arm, cluster-randomised, controlled feasibility trial delivered in groups in two locations in community centres/mosques. Clusters will each comprise 8-10 young women, each attendin
Sponsors
University of Hertfordshire
Eligibility
Sex/Gender
Female
Age
18 Years to 24 Years
Inclusion criteria
Inclusion criteria: 1. Muslim women aged 18-24 years old self-diagnosed or referred from another source with low mood or mild depression and scoring between 5 and 14 on the Patient Health Questionnaire 9 (PHQ-9) scale (74) (low mood/mild symptoms) and willing to participate in the study. 2. Eligible young women with comorbidities that are not contradictions to the study (e.g., chronic pain) 3. Eligible young women on current treatment with antidepressants, other drugs, or psychological therapy will be included provided these individuals are not excluded because of disease severity.
Exclusion criteria
Exclusion criteria: 1. Those who score under 5 or above 14 on the PHQ-9 scale at screening. 2. Those considered unsuitable for whatever reason based on the professional opinion of the mental health professionals during risk assessment (see below). This will include those on current treatment, or with co-morbid conditions that present contraindications to engaging in the study. 3. Those who are identified by the mental health professionals delivering the programme at any point during the conduct of the study as being severely depressed, having psychosis, schizophrenia, or requiring hospitalisation. 4. Participants must be able to read and understand English, although it is not anticipated that this will lead to any exclusions given the age group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The feasibility outcomes to determine progression will be: 1. Referral rate measured using the number of people referred for screening via any route by the end of recruitment 2. Number of exclusions measured by the number of participants who do not consent to take part in the study for any reason including those who do not meet the inclusion criteria during screening 3. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by the end of recruitment 2. Retention rates at follow-up recorded as the number of participants who consent to participate and remain in the study until the end of follow-up at 24 weeks post randomisation 3. Participant engagement and adherence measured using the attendance rate at the intervention sessions as a proportion of the total number of sessions at 6 weeks 4. Feasibility, acceptability, barriers and facilitators to interventions and training of therapists measured using focus groups after the 6-week intervention 5. Data quality and follow-up completion rates, including health economic data measured using missing data at 6 weeks and 24 weeks post randomisation 6. Training and delivery model (adherence, engagement, confidence) measured using intervention logs and rated against the adherence checklist at weekly intervention sessions up to 6 weeks 7. Adverse event rate recorded as the frequency, type and severity of event by treatment arm at the end of follow-up at 24 weeks post randomisation 8. The existence of early evidence that the intervention is not inferior to usual care is measured using analysis of primary outcome data collected at baseline and 24 weeks. 9. Feasibility of required sample size and other requirements for future trial measured using sample size calculation computed using follow-up data at 24 weeks. Further outcome measures are: 1. Distress measured using the Patient Health Questionnaire-9 (PHQ9) at baseline, 6 weeks and 24 weeks 2. Well-being measured using the Warw | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Health-related quality of life measured using the EuroQol EQ-5D-5L scale at baseline, after 6 weeks and 24 weeks 2. Non-health-related resource use for participants measured using the Client Service Receipt Inventory baseline, after 6 weeks and 24 weeks 3. Religious coping measured using R-Cope baseline, after 6 weeks and 24 weeks | — |
Countries
England, United Kingdom
Contacts
Public ContactMegan Smith
Outcome results
None listed