Pragmatic, randomised controlled trial assessing the non-Inferiority of counselling and its effectiveness for depression

Conditions

Moderate and severe depression Mental and Behavioural Disorders Depression

Barkham M, Saxon D, Hardy GE, Bradburn M, Galloway D, Wickramasekera N, Keetharuth AD, Bower P, King M, Elliott R, Gabriel L, Kellett S, Shaw S, Wilkinson T, Connell J, Harrison P, Ardern K, Bishop-Edwards L, Ashley K, Ohlsen S, Pilling S, Waller G, Brazier JE.

2021-05-1417 citations

10.1016/s2215-0366(21)00083-3

A pragmatic randomised controlled trial assessing the non-inferiority of counselling for depression versus cognitive-behaviour therapy for patients in primary care meeting a diagnosis of moderate or severe depression (PRaCTICED): Study protocol for a randomised controlled trial.

Saxon D, Ashley K, Bishop-Edwards L, Connell J, Harrison P, Ohlsen S, Hardy GE, Kellett S, Mukuria C, Mank T, Bower P, Bradburn M, Brazier J, Elliott R, Gabriel L, King M, Pilling S, Shaw S, Waller G, Barkham M.

2017-03-019 citations

10.1186/s13063-017-1834-6

Interventions

Participants are randomised to two arms: 1. Counselling for Depression (CfD): the intervention being evaluated is Counselling for Depression (CfD). CfD is a form of Person-Centred/Exp

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged 18 or over Stage 1: 1. An initial indication by the client that depression is a major focus (ascertained by the PWP during initial assessment of presenting issues) 2. Weekly PHQ-9 scores are greater or equal to 12 at the 3rd or 4th appointment with the PWP 3. Client states no strong objection to either treatment sufficient for them to be unwilling to enter the trial should they be allocated to the alternate treatment Stage 2: 4. Client meets an ICD-10 diagnosis of moderate or severe depression using the Clinical Interview Schedule-Revised (CIS-R) carried out by an independent assessor

Exclusion criteria

Exclusion criteria: Stage 1: 1. Presence of prior diagnosis of personality disorder, bipolar disorder, schizophrenia as indicated in the IAPT Outcomes Toolkit within the service data or from GP referral notes to the service 2. Organic origin of presentation (e.g., dementia) as indicated on referral to the service by the GP 3. Long-term physical condition as denoted in service notes Stage 2: 4. Elevated risk of suicide: if active thoughts of suicide are indicated from the CIS-R, we will implement a risk protocol to inform the PWP or identified practitioner 5. Alcohol or substance dependency: these will be determined by Questions 1 and 2 from Section I (Alcohol) and Section II (Drug) of the Mini-International Neuropsychiatric Interview (M.I.N.I.), which yield diagnoses of current alcohol or drug dependency

Design outcomes

Primary

Measure	Time frame
Depression severity and symptomatology measured by the PHQ-9 at 6 months and at 12-month follow-up.	—

Secondary

Measure	Time frame
1. CORE-OM, BDI-II, EQ-5D-5L, WSAS and GAD-7 2. Healthcare utilisation, measured using an adaptation of the Client Service Receipt Inventory 3. Patient satisfaction, measured using the Client Satisfaction Questionnaire (CSQ), at 6 months Taken at baseline, 6 and 12 months	—

Countries

United Kingdom

Outcome results

None listed