Mild-to-moderate depression/low mood Mental and Behavioural Disorders
Conditions
Interventions
Arm 1 - Intervention (Behavioural Activation):
All participants randomised to the intervention arm will be offered Behavioural Activation (BA). This will comprise 5 modules, delivered in up to 8 week
Sponsors
Tees, Esk and Wear Valleys NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
12 Years to 18 Years
Inclusion criteria
Inclusion criteria: Young people: 1. Aged =12 and =18 years at the date of consent 2. Scores =65 on the depression subscale (10-items) of the Brief Revised Children’s Anxiety and Depression Scale (RCADS). This is the standardised cut-off by which elevated symptoms of depression warrant further assessment and potential intervention. 3. Scores <15 on the PHQ-9A and does not answer ‘more than half of the days’ or ‘nearly every day’ to question 9 of the PHQ-9A or answers “yes” to either SQ3 or SQ4 of the PHQ-9A 4. Provide consent, or assent along with their parent’s consent (if applicable), to participate in the study Professionals: All professionals who have provided support to young people with depression during the research (BA or usual care)
Exclusion criteria
Exclusion criteria: Young people: 1. Have severe depression or an increased risk of suicide, assessed with an interview by a clinical member of the ComBAT team. The assessment interview will only be carried out if the young person scores =15 on the PHQ-9A, or answers ‘more than half of the days’ or ‘nearly every day’ to question 9 of the PHQ-9A, or answers “yes” to either SQ3 or SQ4 of the PHQ-9A. 2. Meet criteria for secondary care (tier 3/high intensity therapy), other than the risk of suicide or severity of the depressive symptoms, such as a learning disability or complex comorbid conditions, confirmed through a discussion with the referrer and the local secondary care team 3. Cannot speak English and do not have a carer or other designated adult to translate the intervention and research materials, and to translate conversations during sessions with a professional
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Anxiety and depression symptoms measured using the Revised Children's Anxiety and Depression Scale (RCADS) - Brief Version (25 items) at 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression symptoms measured using the Children’s Depression Rating Scale-Revised (CDRS-R) at baseline, 6, and 12 months 2. Changes in avoidance and activation measured using the Behavioural Activation for Depression Scale- Short Form (BADS-SF) at baseline, 6, and 12 months 3. Health-related quality of life measured using the Child Health Utility-9 Dimensions (CHU-9D) at baseline, 6, and 12 months 4. Health service use measured using the Resource Utilisation Questionnaire for Adolescents (RUQ-A) at baseline, 6, and 12 months 5. Patient experience of staff interactions measured using the Aspects of Care Questionnaire (ASQ) at 6, and 12 months 6. Intervention fidelity measured using the BA Fidelity Assessment completed throughout the trial 7. Contamination within the control condition measured using the Usual Care Contamination Checklist completed throughout the trial 8. Acceptability of the support received during ComBAT by the young people receiving it and the professionals delivering it measured using qualitative interviews at 6 months | — |
Countries
England, United Kingdom
Contacts
Public ContactLucy Tindall
Outcome results
None listed