Topic: Mental Health
Conditions
Interventions
Participants are randomly allocated to receive Dynamic Interpersonal Therapy or Cognitive Behavioural Therapy over the course of approximately 16 weeks.
Cognitive-Behavioural Therapy:
Study Entry : Single Randomisation only
Sponsors
The Tavistock and Portman NHS Foundation Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age 18 or over 2. Current diagnosis of MDD with or without dysthymic disorder according to DSM-IV criteria 3. Hamilton Depression Rating Scale score above 14 4. 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. Current self-injury 5. Historic severe or persistent self-injury 6. Two or more suicide attempts (lifetime) 7. One or more suicide attempt in the past 12 months 8. Current diagnosis of eating disorder according to DSM-IV criteria 9. Current diagnosis of drugs/alcohol abuse according to DSM-IV criteria 10. Non-English speaking 11. Previous unsuccessful CBT treatment 12. Clinical contra-indication to short-term psychotherapy (e.g. attachment history multiple - separations, serious ongoing trauma in childhood, multiple caregivers suggesting the need for longer term psychotherapy) 13. Evidence of pervasive use of help 14. Highly unstable or insecure life arrangements (e.g. domestic violence)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Updated primary outcome measures as of 03/05/2017: Depression severity is measured using a semi-structured interview, the Hamilton Depression Rating Scale (HDRS-17) at baseline, mid-treatment (8 weeks), and end-of-treatment (approx. 16 weeks). Previous primary outcome measure: Treatment acceptability and feasibility. The main outcomes are recruitment rate, retention in treatment, treatment adherence, and adherence to research protocol. Acceptability will be indicated by the number of sessions attended, including the number of individuals who refuse treatment and feasibility by the number of patients failing to comply with the full clinical and research protocol, the burden of which will be similar to that which could be expected in a full study. We will use the Hamilton Depression Rating Scale (HDRS-17) (17), a structured interview designed to quantify the severity of depressive symptoms in patients already diagnosed as suffering from depressive disorder. | — |
Secondary
| Measure | Time frame |
|---|---|
| Updated secondary outcome measures as of 03/05/2017: 1. Depression severity is measured using the Beck Depression Inventory (BDI-II) at baseline, mid-treatment (8 weeks), and end-of-treatment (approx. 16 weeks) 2. Psychological distress is measured using the Brief Symptom Inventory (BSI) at baseline, mid-treatment (8 weeks), and end-of-treatment (approx. 16 weeks) 3. Quality of life is measured using EuroQOL (EQ-5D) questionnaire at baseline, mid-treatment (8 weeks), and end-of-treatment (approx. 16 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), and end-of-treatment (approx. 16 weeks) 5. Reflective functioning is measured using the Reflective Function Questionnaire (RFQ-54) at baseline, mid-treatment (8 weeks), and end-of-treatment (approx. 16 weeks) 6. Social adjustment is measured using the Revised Social Adjustment Scale (SAS-r) at baseline, mid-treatment (8 weeks) and end-of-treatment (approx. 16 weeks) 7. Interpersonal difficulties are measured using the Inventory of Interpersonal Problems (IIP-64) questionnaire at baseline and end-of-treatment (approx. 16 weeks) 8. Adult attachment is measured using the Experiences in Close Relationships - Revised (ECR-R) questionnaire at baseline and end-of-treatment (approx. 16 weeks) Previous secondary outcome measures: General psychopathology outcomes, psychotherapy process outcome, health-related quality of life and measures of cost-effectiveness. The battery of instruments will include: 1. Brief Symptom Inventory (BSI) 2. Beck Depression Inventory (BDI-II) 3. EuroQol (EQ-5D) 4. Reflective Function Questionnaire (RFQ-54) 5. Self-Esteem Implicit Associ | — |
Countries
United Kingdom
Outcome results
None listed