Tavistock Adult Depression Study (TADS): a randomised controlled trial of psychoanalytic psychotherapy for treatment-resistant/treatment-refractory forms of depression.

BACKGROUND

Long-term forms of depression represent a significant mental health problem for which there is a lack of effective evidence-based treatment. This study aims to produce findings about the effectiveness of psychoanalytic psychotherapy in patients with treatment-resistant/treatment-refractory depression and to deepen the understanding of this complex form of depression.

METHODS/DESIGN INDEX GROUP: Patients with treatment resistant/treatment refractory depression.

DEFINITION & INCLUSION CRITERIA: Current major depressive disorder, 2 years history of depression, a minimum of two failed treatment attempts, ≥14 on the HRSD or ≥21 on the BDI-II, plus complex personality and/or psycho-social difficulties.

EXCLUSION CRITERIA

Moderate or severe learning disability, psychotic illness, bipolar disorder, substance dependency or receipt of test intervention in the previous two years.

DESIGN

Pragmatic, randomised controlled trial with qualitative and clinical components.

TEST INTERVENTION

18 months of weekly psychoanalytic psychotherapy, manualised and fidelity-assessed using the Psychotherapy Process Q-Sort.

CONTROL CONDITION

Treatment as usual, managed by the referring practitioner.

RECRUITMENT

GP referrals from primary care.

RCT MAIN OUTCOME

HRSD (with ≤14 as remission).

SECONDARY OUTCOMES

depression severity (BDI-II), degree of co-morbid disorders Axis-I and Axis-II (SCID-I and SCID-II-PQ), quality of life and functioning (GAF, CORE, Q-les-Q), object relations (PROQ2a), Cost-effectiveness analysis (CSRI and GP medical records).

FOLLOW-UP: 2 years. Plus: a). Qualitative study of participants' and therapists' problem formulation, experience of treatment and of participation in trial. (b) Narrative data from semi-structured pre/post psychodynamic interviews to produce prototypes of responders and non-responders. (c) Clinical case-studies of sub-types of TRD and of change.

DISCUSSION

TRD needs complex, long-term intervention and extended research follow-up for the proper evaluation of treatment outcome. This pushes at the limits of the design of randomised therapeutic trials. We discuss some of the consequent problems and suggest how they may be mitigated.

TRIAL REGISTRATION

Current Controlled Trials ISRCTN40586372.