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21 May 2012
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| [ Print-friendly version ] |
| Tavistock Adult Depression Study: Comparing the effectiveness of usual GP care with once weekly psychoanalytic psychotherapy for people suffering from chronic, treatment-resistant depression |
| ISRCTN | ISRCTN40586372 |
| ClinicalTrials.gov identifier | |
| Public title | Tavistock Adult Depression Study: Comparing the effectiveness of usual GP care with once weekly psychoanalytic psychotherapy for people suffering from chronic, treatment-resistant depression |
| Scientific title | Randomised Controlled Trial comparing the effectiveness of usual GP care with once weekly psychoanalytic psychotherapy in cases of refractory depression |
| Acronym | TADS |
| Serial number at source | N/A |
| Study hypothesis |
The condition under study is chronic, treatment-resistant depression, which represents a significant mental health problem worldwide. Approximately 12% of depressed patients experience these long-term, relapsing and complex forms of depression with significant impact on their work functioning, interpersonal relationships and quality of life. Until recently, there has been a shortage of research to guide the clinical management of these patients. There is a considerable a lack of effective evidence-based treatment available to date.
Patients treated with once weekly, individual psychoanalytic psychotherapy will show improvements relative to baseline on the measures chosen. They will show greater benefits than patients who are treated with usual GP care (the TAU group). |
| Lay summary | Lay summary under review |
| Ethics approval |
West Midlands Research Ethics Committee approved on 28th May 2002, reference number: MREC/0/7/35
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| Study design | Intention-to-treat pragmatic single-centre randomised controlled trial |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Treatment-resistant depression |
| Participants - inclusion criteria |
1. Male and female primary care patients between 18 to 65 years of age
2. Major depressive disorder or dysthymia based on Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV) criteria and minimum symptom severity on the Beck Depression Inventory (BDI) of 21 or above and 14 or above on the Hamilton Rating Scale for Depression (HRSD) 3. Minimum of a two-year history of depression 4. Atleast two previous failed treatment attempts, one of which was with an anti-depressant 5. Able to speak conversational English and be seen at the Tavistock Clinic, London 6. Willing to enter a randomised controlled trial |
| Participants - exclusion criteria |
Primary care patients with:
1. Recent (previous five years) history of psychosis 2. Recent (previous five year) history of bi-polar disorder 3. Moderate or severe learning disabilities 4. Recent history (previous two years) of psychiatric input for, or diagnosis of, substance dependency (alcohol abuse more than 21 units/week; drug abuse more than 4/week) 5. Patients currently in psychological therapy 6. Patients who have received psychoanalytic psychotherapy in the previous two years |
| Anticipated start date | 01/06/2002 |
| Anticipated end date | 31/12/2004 |
| Status of trial | Completed |
| Patient information material | Patient information material can be found at http://www.tavistockandportman.nhs.uk/sites/default/files//Information for patients interested in taking part.pdf |
| Target number of participants | 129 participants across both arms |
| Interventions |
Intervention group: individual psychoanalytic psychotherapy for depression (PPD), carried out once weekly for 18 months by senior clinicians from the Tavistock Clinic, adult department.
Control group: Treatment-as-usual as provided and managed by the referring primary care practitioner. Total duration of treatment or review period is 18 months. Follow-up period is 2 years. |
| Primary outcome measure(s) | Change in depression severity as indicated by the independent, double-rated Hamilton Rating Scale of Depression (HRSD, Hamilton, 1967) at baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up. It is a semi-structured interview consisting of 21 depression items, which yield a range of scores from 0 - 62. |
| Secondary outcome measure(s) |
1. Self-report depression severity: assessed using the Beck Depression Inventory (BDI II, Beck et al, 1996). It consists of 21 items, which yield a range of scores from 0 to 63. Each items is to be scored on a Likert-scale ranging from 0-3 (0 = depression symptom not present, 3 depression symptom severe). It is assessed at baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months,6 months follow-up, 12 months follow-up and 24 months follow-up
2. Axis I disorders: assessed using the Structured Clinical Interview for DSM IV, research version (SCID-I, First et al, 2001). This semi-structured clinical interview assesses subjects on all five axes of DSM IV diagnosis. The diagnoses assessed in the TADS trial are Major depressive disorder (MDD), dysthymia, alcohol abuse/dependency, drug abuse/dependency, anxiety disorders, obsessive–compulsive disorder (OCD), and eating disorders. It is assessed and blindly double-rated at baseline, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up 3. Axis II personality disorders (PD): the Structured Clinical Interview for DSM IV Personality Disorders Questionnaire (SCID-II-PQ. First et al., 1997)) is used to identify patients with probable Axis II disorders. It is a self-report measure asking for a yes or no response to 104 questions. It is assessed and blindly double-rated at baseline, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up 4. Personality functioning: the information yielded by the Tavistock Psychodynamic Interview (TPI) carried at baseline and six-months follow-up allows Axis-II pathology to be assessed with the Shedler-Westen Q-Sort, Shedler and Westen, 2004. The information also permits the assessment of personality pathology according to the revised criteria of the proposed DSM-V. Will be assessed and blindly double-rated at baseline and 6 months follow-up 5. Object relations: assessed using the Persons Relating to Others Questionnaire (PROQ2a, Birtchnell, 1999). It is a 48-item self-report questionnaire, which evaluates style of personal relating in terms of close (involving) vs. distant (seeking separation) and upper (relating from above downwards) vs. lower (relating from below upwards). The measure uses eight scales which are structured around these two axes. Participants are asked to tick against 48 statements whether there are "nearly always true", "quite often true", "sometimes true" or "rarely true". It is assessed at baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up 6. Social functioning: the Global Assessment of Functioning scale (GAF, Hilsenroth et al., 2000) is used to assess psychological, social and occupational functioning positioned on a hypothetical, 0 to 100 continuum of mental health - illness. It also comprises Axis V of the DSM-IV. GAF scores are made on the basis of the aggregated total of information available on the subject. It is assessed by the researcher and double-rated at baseline, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up 7. Subjective well-being: is assessed using the Clinical Outcomes in Routine Evaluation Outcome Measure (CORE-OM, Evans et al., 2000). This 34-item self-report instrument assesses subjective well-being, symptoms, function, and risk. Participants are asked to rate whether 34 statements are "not at all true", "only occasionally true", "sometimes true", "often true" or "most or all of the time true". It is assessed at baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up 8. Quality of life: is assessed using the Quality of Life Enjoyment and Satisfaction Questionnaire (Q-LES-Q, Endicott et al., 1993) . It is a self-report instrument consisting of 93 items grouped into eight quality of life areas - physical health, subjective feelings, work, household duties, school, leisure activities, social relationships, and general activities. Participant rate each item on a 5-point scale of enjoyment/satisfaction over the previous week (0 = not at all or never, 5 = frequently or all the time). Mean scores can be derived from the eight summary scales with a range from 0-100, with higher scores indicating better quality of life. It is assessed at baseline, 3 months, 6 months, 9 months, 12 months, 15 months, 18 months, 6 months follow-up, 12 months follow-up and 24 months follow-up 9. Number of depression-free days: at baseline, and at all subsequent review/ follow-up interviews, participants are asked to estimate the number of depression-free days experienced in the preceding month |
| Sources of funding |
1. Tavistock Charitable Foundation (UK)
2. Evaluation of Research Proposals and Results Subcommittee (CERP) of the International Psychoanalytic Association (IPA) (UK) |
| Trial website | http://www.tavistockandportman.nhs.uk/adultdepressionstudy |
| Publications | |
| Contact name | Prof Peter Fonagy |
| Address |
Psychoanalysis Unit
Research Dept. of Clinical, Education & Health Psychology University College London 10-19 Torrington Place |
| City/town | London |
| Zip/Postcode | WC1E 7HJ |
| Country | United Kingdom |
| Tel | +44 (0)20 7679 1943 |
| Fax | +44 (0)20 7916 8502 |
| p.fonagy@ucl.ac.uk | |
| Sponsor | The Tavistock Charitable Foundation (UK) |
| Address |
Tavistock and Portman Trustees
c/o Dr M. Patrick 120 Belsize Lane |
| City/town | London |
| Zip/Postcode | NW3 5BE |
| Country | United Kingdom |
| Tel | +44 (0)20 7435 7111 |
| Fax | +44 (0)20 7447 3709 |
| MPatrick@tavi-port.nhs.uk | |
| Sponsor website: | http://opencharities.org/charities/1049530 |
| Date applied | 18/11/2011 |
| Last edited | 11/01/2012 |
| Date ISRCTN assigned | 11/01/2012 |
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