Topic: Mental Health Research Network
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years, male or female 2. Current diagnosis of Major depressive disorder (MDD) with or without dysthymic disorder according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria 3. Hamilton Depression Rating Scale score above 14 4. Patient Health Questionnaire (PHQ) score above 10 5. Confirmed need for high-intensity treatment either at triage, following referral, or by low-intensity worker and supervisor
Exclusion criteria
Exclusion criteria: 1. Current psychotic symptoms or bipolar disorder 2. Current use of antipsychotic medication 3. Complex Personality Disorder 4. Historic or current self-injury/parasuicide 5. Historic or current eating disorder 6. Current excessive use of drugs/alcohol 7. Non-English speaking 8. Participation in another depression clinical trial within the last year where subject has received CBT 9. Previous unsuccessful CBT treatment 10. Clinical contra-indication to short-term psychotherapy (e.g. attachment history - multiple separations, serious ongoing trauma in childhood, multiple care-givers - suggesting the need for longer term psychotherapy) 11. Evidence of pervasive use of help 12. Highly unstable or insecure life arrangements (e.g. domestic violence)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome as of 14/06/2016: Depression severity is measured using a semi-structured interview, the Hamilton Depression Rating Scale (HDRS-17) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks). Original primary outcome: Hamilton Depression Rating Scale (HDRS-17) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome as of 14/06/2016: 1. Depression severity is measured using the Beck Depression Inventory (BDI-II) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks) 2. Psychological distress is measured using the Brief Symptom Inventory (BSI) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks) 3. Quality of life is measured using EuroQOL (EQ-5D) questionnaire at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks) 4. Comorbidity of a range of psychiatric diagnoses are measured using the MINI+ interview (MINI International Neuropsychiatric Interview) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks) 5. Reflective functioning is measured using the Reflective Function Questionnaire (RFQ-54) at baseline, mid-treatment (8 weeks), end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks) 6. Social adjustment is measured using the Revised Social Adjustment Scale (SAS-r) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks), and long-term follow-ups (52 and 86 weeks) 7. Interpersonal difficulties are measured using the Inventory of Interpersonal Problems (IIP-64) questionnaire at baseline, end-of-treatment (approx.. 16 weeks), and long-term follow-ups (52 and 86 weeks) 8. Adult attachment is measured using the Experiences in Close Relationships - Revised (ECR-R) questionnaire at baseline, end-of-treatment (approx.. 16 weeks), and long-term follow-ups (52 and 86 weeks) Original secondary outcome measures: 1. Beck Depression Inventory (BDI-II) at baseline, mid-treatment (8 weeks) end-of-treatment (approx. 16 weeks) | — |
Countries
United Kingdom