MedPath

Improving mood and preventing relapse with psychoanalytic psychotherapy and cognitive behaviour therapy

Not Applicable
Completed
Conditions
Mental and Behavioural Disorders
Depressive episode
nipolar major depression of moderate to severe severity
Registration Number
ISRCTN83033550
Lead Sponsor
Cambridgeshire and Peterborough NHS Foundation Trust (UK)
Brief Summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21752257 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27465740 2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27914903 2017 results in: http://www.ncbi.nlm.nih.gov/pubmed/28394249 2020 qualitative study results in https://pubmed.ncbi.nlm.nih.gov/33228744/ (added 25/11/2020)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
540
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

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)

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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
NameTimeMethod
<br> 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)<br> 2. The Children's Depression Rating Scale completed by the clinician treating the patient (range 17-113; higher scores = greater severity)<br> 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.<br><br> All secondary outcome measures will be assessed at 0, 6, 12, 36, 52 and 86 weeks.<br>
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