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Improving mood and preventing relapse with psychoanalytic psychotherapy and cognitive behaviour therapy
ISRCTN ISRCTN83033550
DOI 10.1186/ISRCTN83033550
ClinicalTrials.gov identifier
EudraCT number
Public title Improving mood and preventing relapse with psychoanalytic psychotherapy and cognitive behaviour therapy
Scientific title A pragmatic superiority relapse prevention randomised controlled trial of short term psychodynamic psychotherapy (STPP), cognitive behaviour therapy (CBT) and active clinical care (ACC) in adolescents with moderate to severe depression attending routine child and adolescent mental health clinics
Acronym IMPACT (Improving Mood with Psychoanalytic Psychotherapy and Cognitive Behaviour Therapy)
Serial number at source HTA 06/05/01
Study hypothesis We have a superiority hypothesis which will test whether i) short term psychodynamic psychotherapy (STPP) and cognitive behaviour therapy (CBT) are independently more effective than active clinical care (ACC); ii) STPP is more effective than CBT.

Cost-effectiveness: We will test the hypothesis that the additional costs of specialised treatment are justified by improvements in effectiveness, and possibly decreased use of health and social care services in the medium term.

We also want to determine whether the treatments differ a) in user satisfaction, and b) within subgroups defined by severity.

More details can be found at: http://www.hta.ac.uk/1731
Lay summary Not provided at time of registration
Ethics approval Cambridgeshire 2 Research Ethics Committee, approved on 09/10/2009 (ref: 09/H0308/137)
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Unipolar major depression of moderate to severe severity
Participants - inclusion criteria 1. Both males and females, age 11 through 17 years
2. Current moderate to severe unipolar major depression (MD) according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) criteria
Participants - exclusion criteria 1. Generalised learning problems (clinical diagnosis) or a pervasive developmental disorder that results in an inability to complete the questionnaires, or both
2. Pregnant, or currently having sexual relations without reliable contraception
3. Currently taking another medication that may interact with a selective serotonin reuptake inhibitor (SSRI) and unable to stop this medication (uncommon)
Anticipated start date 01/10/2009
Anticipated end date 31/03/2015
Status of trial Ongoing
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 540
Interventions Experimental interventions:

i. Short term psychoanalytic psychotherapy (STPP) (n=180). 30 weekly sessions of treatment; total duration of follow up: 86 weeks from entry, 56 weeks from end of treatment

ii. Cognitive behaviour therapy (CBT) (n=180). 20 weekly sessions of treatment; total duration of follow up: 86 weeks from entry, 66 weeks from end of treatment

Comparator:

Active clinical care (ACC) (n=180). 12 weekly sessions of treatment; total duration of follow up: 74 weeks from entry , 66 weeks from end of treatment

All 3 arms will be allowed to prescribe oral fluoxetine 20-40 mg daily.

The initial dosage will be 10 mg (as syrup) increased to 20 mg once a day, if there are no side effects. If there is no response by 6 weeks the dose will be increased to 40 mg. The medication will be monitored by the research child psychiatrist over the trial period. Compliance will be monitored by counting returned pills/syrup bottles (in NHS practice frequent blood tests would not be acceptable and assays of SSRI levels are seldom available).
Primary outcome measure(s) Persistence of self-reported depressive symptoms at 52 weeks and recurrence of symptoms by 86 weeks. The instrument is the Mood and Feelings Questionnaire (MFQ) consisting of 33 items (range 0-66, higher scores more symptoms, >27 = clinical level of depression).
Secondary outcome measure(s) 1. The Health of the Nation Outcome Scale for Children and Adolescents (HoNOSCA) will be completed by the interviewer (blind to treatment arm) (range 0-68, higher score = greater level of personal impairment)
2. The Children's Depression Rating Scale completed by the clinician treating the patient (range 17-113; higher scores = greater severity)
3. Psychiatric diagnosis: Children's Schedule for Affective Disorders (K-Sads); interviewer based diagnostic measure recording presence or absence of unipolar depression and other psychiatric diagnoses at each assessment point.

All secondary outcome measures will be assessed at 0, 6, 12, 36, 52 and 86 weeks.
Sources of funding 1. NIHR Health Technology Assessment Programme - HTA (UK) (main funding)
2. Department of Health (UK)
Trial website
Publications 2011 protocol in http://www.ncbi.nlm.nih.gov/pubmed/21752257
Contact name Prof  Ian  Goodyer
  Address Cambridgeshire and Peterborough NHS Foundation Trust
Developmental Psychiatry
Douglas House
18b Trumpington Road
  City/town Cambridge
  Zip/Postcode CB2 8AH
  Country United Kingdom
  Tel +44 (0)1223 746040
  Fax +44 (0)1223 746122
  Email ig104@cam.ac.uk
Sponsor Cambridgeshire and Peterborough NHS Foundation Trust (UK)
  Address Research and Development Department
Douglas House
18b Trumpington Road
  City/town Cambridge
  Zip/Postcode CB2 8AH
  Country United Kingdom
  Tel +44 (0)1223 746145
  Email natercia.godinho@cpft.nhs.uk
  Sponsor website: http://www.cpft.nhs.uk/
Date applied 14/10/2009
Last edited 22/11/2011
Date ISRCTN assigned 15/10/2009
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