Improving mood and preventing relapse with psychoanalytic psychotherapy and cognitive behaviour therapy
| ISRCTN | ISRCTN83033550 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83033550 |
| Protocol serial number | HTA 06/05/01 |
| Sponsor | Cambridgeshire and Peterborough NHS Foundation Trust (UK) |
| Funders | Health Technology Assessment Programme, Department of Health (UK) |
- Submission date
- 14/10/2009
- Registration date
- 15/10/2009
- Last edited
- 10/06/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
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
Contact information
Scientific
Cambridgeshire and Peterborough NHS Foundation Trust
Developmental Psychiatry
Douglas House
18b Trumpington Road
Cambridge
CB2 8AH
United Kingdom
| Phone | +44 (0)1223 746040 |
|---|---|
| ig104@cam.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| 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 |
| Study acronym | IMPACT (Improving Mood with Psychoanalytic Psychotherapy and Cognitive Behaviour Therapy) |
| Study objectives | 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. |
| Ethics approval(s) | Cambridgeshire 2 Research Ethics Committee, 09/10/2009, ref: 09/H0308/137 |
| Health condition(s) or problem(s) studied | 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 |
| 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). |
| Key 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) |
| Completion date | 31/03/2015 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 17 Years |
| Sex | All |
| Target sample size at registration | 540 |
| Key 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 |
| Key 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) |
| Date of first enrolment | 01/10/2009 |
| Date of final enrolment | 31/03/2015 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
CB2 8AH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 28/07/2016 | Yes | No | |
| Results article | results | 01/02/2017 | Yes | No | |
| Results article | results | 01/03/2017 | Yes | No | |
| Results article | qualitative study results | 23/11/2020 | 25/11/2020 | Yes | No |
| Results article | Longitudinal network analysis | 09/06/2025 | 10/06/2025 | Yes | No |
| Protocol article | protocol | 13/07/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
10/06/2025: Publication reference added.
25/11/2020: Publication reference added.
11/04/2017: Publication reference added.
06/12/2016: Publication reference added.
28/07/2016: Publication reference added.
15/04/2016: Plain English summary added.
