Plain English Summary

Not provided at time of registration

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.hta.ac.uk/1731

Ethics approval

Cambridgeshire 2 Research Ethics Committee, approved on 09/10/2009 (ref: 09/H0308/137)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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:

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).

Intervention type

Other

Phase

Not Applicable

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

http://www.cpft.nhs.uk/

Funders

Funder type

Government

Funder name

NIHR Health Technology Assessment Programme - HTA (UK) (main funding)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

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

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.

Editorial Notes