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
ig104@cam.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Ian Goodyer
ORCID ID
Contact details
Cambridgeshire and Peterborough NHS Foundation Trust
Developmental Psychiatry
Douglas House
18b Trumpington Road
Cambridge
CB2 8AH
United Kingdom
+44 (0)1223 746040
ig104@cam.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov 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
Acronym
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: http://www.nets.nihr.ac.uk/projects/hta/060501
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0016/51280/PRO-06-05-01.pdf
Ethics approval
Cambridgeshire 2 Research Ethics Committee, 09/10/2009, ref: 09/H0308/137
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Unipolar major depression of moderate to severe severity
Intervention
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
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).
Intervention type
Mixed
Phase
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
01/10/2009
Overall trial end date
31/03/2015
Reason abandoned
Eligibility
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
Patient
Age group
Child
Gender
Both
Target number of participants
540
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
01/10/2009
Recruitment end date
31/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Cambridgeshire and Peterborough NHS Foundation Trust
Cambridge
CB2 8AH
United Kingdom
Sponsor information
Organisation
Cambridgeshire and Peterborough NHS Foundation Trust (UK)
Sponsor details
Research and Development Department
Douglas House
18b Trumpington Road
Cambridge
CB2 8AH
United Kingdom
+44 (0)1223 746145
natercia.godinho@cpft.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Government
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
Location
United Kingdom
Funder name
Department of Health (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
01/10/2016
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21752257
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27465740
Publication citations
-
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.
-
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.