Specialty: Mental Health, Primary sub-specialty: Depression
Conditions
Interventions
This is a parallel groups, superiority pragmatic RCT with 1:1 allocation to MBCT-SH or CBT-SH with blinded assessments at all time points. Participants are blind to the hypothesised direction of effec
Sponsors
Sussex Partnership NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Be aged 18 years or over 2. Meet diagnostic criteria on the revised Clinical Interview Schedule (CIS-R) for a primary diagnosis of a depressive episode, or mixed anxiety and depression 3. Score 10 or more on the PHQ-9 at their initial IAPT assessment (the cut-off for a major depressive episode); and 4. Have sufficient literacy skills to read and understand the self-help materials
Exclusion criteria
Exclusion criteria: 1. Have severe symptoms of depression (a score 20 or more on the PHQ-9); 2. Score of 4 on the CIS-R suicidality scale 3. Express a strong preference (5/5) for one intervention over the other on the Treatment Preference 5. Question such that if randomised to the non-preferred intervention they would be likely to drop out of the intervention.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| 1. Depression symptom severity is measured using the change in PHQ-9 score from baseline to follow-up (42 weeks post-randomisation) is a secondary outcome for the study at follow-up 2. Generalised anxiety is measured using the GAD-7 is a 7-item measure of generalised anxiety used in IAPT. Items are rated on a 4-point scale and the measure has excellent psychometric properties from baseline to post-intervention and from baseline to follow-up 3. Wellbeing is measured using the short version of the Warwick Edinburgh Mental Wellbeing Scale consists of 7 questions rated on a 5-point scale designed to measure wellbeing from baseline to post-intervention and from baseline to follow-up are secondary outcomes 4. Functioning is measured using the Work and Social Adjustment Scale (WSAS) is a 5-item measure of daily occupational and social functioning that is used routinely in IAPT from baseline to post-intervention and from baseline to follow-up are secondary outcomes 5. Mindfulness is measured using the 15-item version of the Five-Facet Mindfulness Questionnaire. from baseline to post-intervention and from baseline to follow-up are secondary outcomes 6. Service use is measured using the a self-report version of the Adult Service Use Schedule (ADSUS) will be used to collect data on resource used to estimate costs and will take the health and social services perspective at collected at baseline, post-intervention (16 weeks post-randomisation) and follow-up (42 weeks post-randomisation) 7. Health-related quality of life is measured using the EQ-5D is a five-dimension, generic, preference-based measure of health-related quality of life covering mobility, self-care, usual activities, pain/discomfort and anxiety/depression.at baseline, post-intervention (16 weeks post-randomisation) and follow-up (42 weeks post-randomisation). Qualitative Evaluation: The | — |
Primary
| Measure | Time frame |
|---|---|
| Depression symptom severity at post-intervention. The PHQ-9 is a 9-item self-report measure of depression symptom severity used in all IAPT services. Items are rated on a four-point scale. The primary outcome for this study is change in PHQ-9 score from baseline to 16 weeks post-randomisation | — |
Countries
England, United Kingdom
Outcome results
None listed