Evaluating Augmented Depression Therapy (ADepT): study protocol for a pilot randomised controlled trial
| Autor: | Nigel Reed, Willem Kuyken, Gerjo Kok, Gerda Kraag, Christabel Owens, Michelle L. Moulds, Nicholas J. Moberly, Emily Widnall, Nicole Geschwind, David Richards, Andrew K. MacLeod, Anne Spencer, Kim Wright, Rachel V. Handley, Barnaby D. Dunn, Rod S Taylor, John Campbell |
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| Přispěvatelé: | Section Applied Social Psychology, RS: FPN WSP II, Section Clinical Psychology, RS: FPN CPS III |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
DISORDER
medicine.medical_specialty Mixed methods mixed methods media_common.quotation_subject Medicine (miscellaneous) Major depressive disorder Feasibility study VALIDATION Pleasure law.invention ACTIVATION 03 medical and health sciences STRUCTURED INTERVIEW GUIDE Study Protocol 0302 clinical medicine Randomized controlled trial law medicine 030212 general & internal medicine VALIDITY COGNITIVE-BEHAVIORAL THERAPY Cognitive Behavioural therapy SCALE media_common Pilot study lcsh:R5-920 major depressive disorder business.industry pilot study Outcome measures Anhedonia feasibility study Adept Cognition Augmented Depression Therapy MAJOR DEPRESSION cognitive behavioural therapy medicine.disease NEGATIVE AFFECT augmented depression therapy Physical therapy EXPERIENCE medicine.symptom Process evaluation business lcsh:Medicine (General) 030217 neurology & neurosurgery |
| Zdroj: | Pilot and Feasibility Studies Dunn, B D, Widnall, E & al., E 2019, ' Evaluating Augmented Depression Therapy (ADepT) : study protocol for a pilot randomised controlled trial ', Pilot and Feasibility Studies, vol. 5, 63 (2019) . https://doi.org/10.1186/s40814-019-0438-1 Pilot and Feasibility Studies, 5(1):63. BioMed Central Ltd Pilot and Feasibility Studies, Vol 5, Iss 1, Pp 1-16 (2019) |
| ISSN: | 2055-5784 |
| Popis: | Background While existing psychological treatments for depression are effective for many, a significant proportion of depressed individuals do not respond to current approaches and few remain well over the long-term. Anhedonia (a loss of interest or pleasure) is a core symptom of depression which predicts a poor prognosis but has been neglected by existing treatments. Augmented Depression Therapy (ADepT) has been co-designed with service users to better target anhedonia alongside other features of depression. This mixed methods pilot trial aims to establish proof of concept for ADepT and to examine the feasibility and acceptability of a future definitive trial evaluating the clinical and cost-effectiveness of ADepT, compared to an evidence-based mainstream therapy (Cognitive Behavioural Therapy; CBT) in the acute treatment of depression, the prevention of subsequent depressive relapse, and the enhancement of wellbeing. Methods We aim to recruit 80 depressed participants and randomise them 1:1 to receive ADepT (15 weekly acute and 5 booster sessions in following year) or CBT (20 weekly acute sessions). Clinical and health economic assessments will take place at intake and at 6-, 12-, and 18-month follow-up. Reductions in PHQ-9 depression severity and increases in WEMWBS wellbeing at 6-month assessment (when acute treatment should be completed) are the co-primary outcomes. Quantitative and qualitative process evaluation will assess mechanism of action, implementation issues, and contextual moderating factors. To evaluate proof of concept, intake-post effect sizes and the proportion of individuals showing reliable and clinically significant change on outcome measures in each arm at each follow-up will be reported. To evaluate feasibility and acceptability, we will examine recruitment, retention, treatment completion, and data completeness rates and feedback from patients and therapists about their experience of study participation and therapy. Additionally, we will establish the cost of delivery of ADepT. Discussion We will proceed to definitive trial if any concerns about the safety, acceptability, feasibility, and proof of concept of ADepT and trial procedures can be rectified, and we recruit, retain, and collect follow-up data on at least 60% of the target sample. Trial registration ISCRTN85278228, registered 27/03/2017 Electronic supplementary material The online version of this article (10.1186/s40814-019-0438-1) contains supplementary material, which is available to authorized users. |
| Databáze: | OpenAIRE |
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