Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Depression in adolescents is a very serious problem with over half of those diagnosed retaining their problem into young adulthood. The current best treatment involves psychological treatment together with an anti-depressant (fluoxetine). After 6 months only 20% show full recovery, 30% improve but are not fully recovered, a further 30% are left with a high number of residual depressive symptoms, and 20% do not respond at all. The reasons for the poor responses are unclear. Thus many patients remain at considerable risk of relapse in the weeks and months following the end of treatment. Given that depression in adulthood is one of the three most important health burdens on UK society, and adolescent brain functioning may influence later development, finding ways to decrease the risk of adolescent recurrent depression through adequate treatment of early episodes would be a major public health advance. The aim of this study is to find out whether increasing the amount and quality of psychological treatments offered in one or both of two ways will increase treatment response, reduce the level of residual symptoms and decrease the proportion of patients at risk for depressive relapse.

Who can participate?
Patients aged 11 - 17 with severe unipolar major depression

What does the study involve?
Participants are randomly allocated to one of three groups. One group receives 'treatment as usual' (TAU), generally addressing the life situation of the adolescent and the family plus fluoxetine. The other two groups also receive TAU but also have either brief psychodynamic psychotherapy or cognitive behaviour therapy, the treatments with the strongest evidence and most commonly offered routinely in the NHS but often inadequately or for too short a period. We do not expect that the specialist therapies on their own would effectively treat depression but we predict that, in conjunction with TAU, one or both the therapies will generate better outcomes than TAU alone over a 12-month period.

What are the possible benefits and risks of participating?
Not provided at time of registration

Where is the study run from?
Cambridgeshire and Peterborough NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
October 2009 to March 2015

Who is funding the study?
1. NIHR Health Technology Assessment Programme - HTA (UK)
2. Department of Health (UK)

Who is the main contact?
Prof. Ian Goodyer

Trial website

Contact information



Primary contact

Prof Ian Goodyer


Contact details

Cambridgeshire and Peterborough NHS Foundation Trust
Developmental Psychiatry
Douglas House
18b Trumpington Road
United Kingdom
+44 (0)1223 746040

Additional identifiers

EudraCT number number

Protocol/serial number

HTA 06/05/01

Study information

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


IMPACT (Improving Mood with Psychoanalytic Psychotherapy and Cognitive Behaviour Therapy)

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:
Protocol can be found at:

Ethics approval

Cambridgeshire 2 Research Ethics Committee, 09/10/2009, ref: 09/H0308/137

Study design

Randomised controlled trial

Primary study design


Secondary study design

Randomised controlled trial

Trial setting


Trial type


Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet


Unipolar major depression of moderate to severe severity


Experimental interventions:
1. 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
2. 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

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).

Intervention type



Drug names

Primary outcome measures

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 measures

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.

Overall trial start date


Overall trial end date


Reason abandoned


Participant 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

Participant type


Age group




Target number of participants


Participant 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)

Recruitment start date


Recruitment end date



Countries of recruitment

United Kingdom

Trial participating centre

Cambridgeshire and Peterborough NHS Foundation Trust
United Kingdom

Sponsor information


Cambridgeshire and Peterborough NHS Foundation Trust (UK)

Sponsor details

Research and Development Department
Douglas House
18b Trumpington Road
United Kingdom
+44 (0)1223 746145

Sponsor type




Funder type


Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government


United Kingdom

Funder name

Department of Health (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date


Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2011 protocol in:
2016 results in:

Publication citations

  1. Protocol

    Goodyer IM, Tsancheva S, Byford S, Dubicka B, Hill J, Kelvin R, Reynolds S, Roberts C, Senior R, Suckling J, Wilkinson P, Target M, Fonagy P, Improving mood with psychoanalytic and cognitive therapies (IMPACT): a pragmatic effectiveness superiority trial to investigate whether specialised psychological treatment reduces the risk for relapse in adolescents with moderate to severe unipolar depression: study protocol for a randomised controlled trial., Trials, 2011, 12, 175, doi: 10.1186/1745-6215-12-175.

  2. Results

    N Midgley, D Isaacs, K Weitkamp, M Target, The experience of adolescents participating in a randomised clinical trial in the field of mental health: a qualitative study, Trials, 2016, 17, 364, doi: 10.1186/s13063-016-1474-2.

Additional files

Editorial Notes

28/07/2016: Publication reference added. 15/04/2016: Plain English summary added.