TY - JOUR
T1 - Preliminary clinical and cost effectiveness of augmented depression therapy versus cognitive behavioural therapy for the treatment of anhedonic depression (ADepT)
T2 - a single-centre, open-label, parallel-group, pilot, randomised, controlled trial
AU - Dunn, Barnaby D.
AU - Widnall, Emily
AU - Warbrick, Laura
AU - Warner, Faith
AU - Reed, Nigel
AU - Price, Alice
AU - Kock, Merle
AU - Courboin, Clara
AU - Stevens, Rosie
AU - Wright, Kim
AU - Moberly, Nicholas J.
AU - Geschwind, Nicole
AU - Owens, Christabel
AU - Spencer, Anne
AU - Campbell, John
AU - Kuyken, Willem
N1 - Funding Information:
NIHR Career Development Fellowship.The trial was funded by a Career Development Fellowship awarded to the principal investigator (BD) by the National Institute for Health Research (NIHR) in the UK, grant number CDF-2014-07-10. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. MK is supported by Research Foundation Flanders (FWO-Vlaanderen) under a PhD fellowship (11|1622N). The AccEPT service that hosted the research was commissioned by the National Health Service North, Eastern and Western Devon Clinical Commissioning Group (now the NHS Devon Integrated Care Board) and hosted at the Mood Disorders Centre, University of Exeter. Excess treatment costs to cover the costs of experimental care during the study were provided by NEW Devon Clinical Commissioning Group and South Devon & Torbay Clinical Commissioning Group (now both the NHS Devon Integrated Care Board). The authors are grateful to the Exeter Collaboration for Academic Primary Care (APEX), the South West Clinical Research Network, the Research and Development Teams in Devon Partnership NHS Trust, TALKWORKS IAPT (now NHS Talking Therapies) service, members of the Mood Disorders Centre Lived Experience Group, and the AccEPT clinic for assistance with the project. The authors would also like to thank Rachel Handley, Andy MacLeod, Michelle Moulds, Gerda Kraag, David Richards, Gerjo Kok, Rob DeRubeis, Katie Marchant, Richard Moore, Rachel Barter, Georgina Clifford, Richard Meiser-Stedman and other members of the TSC/DMEC for help with this work. The authors would also like to express gratitude to the trial therapists and supervisors, including Joanna Mackenzie, Hugo Durward, Kay Octigan, Megan Colletta, Susie Kroger, Faye Small and Miriam Cassell. We would also like to acknowledge and remember our friend and colleague Peter Mason (trial therapist), who passed away in 2020. Finally, the authors thank all the study participants for taking part.
Funding Information:
The trial was funded by a Career Development Fellowship awarded to the principal investigator (BD) by the National Institute for Health Research (NIHR) in the UK, grant number CDF-2014-07-10. The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care . MK is supported by Research Foundation Flanders (FWO-Vlaanderen) under a PhD fellowship (11|1622N).
Publisher Copyright:
© 2023 The Author(s)
PY - 2023/7/1
Y1 - 2023/7/1
N2 - Background: Anhedonia (reduced interest/pleasure) symptoms and wellbeing deficits are core to depression and predict a poor prognosis. Current depression psychotherapies fail to target these features adequately, contributing to sub-optimal outcomes. Augmented Depression Therapy (ADepT) has been developed to target anhedonia and wellbeing. We aimed to establish clinical and economic proof of concept for ADepT and to examine feasibility of a future definitive trial comparing ADepT to Cognitive Behavioural Therapy (CBT). Methods: In this single-centre, open-label, parallel-group, pilot randomised controlled trial, adults meeting diagnostic criteria for a current major depressive episode, scoring =10 on the Patient Health Questionnaire (PHQ-9) and exhibiting anhedonic features (PHQ-9 item 1 = 2) were recruited primarily from high intensity Improving Access to Psychological Therapy (IAPT) service waiting lists in Devon, UK. Participants were randomised to receive 20 sessions of CBT or ADepT, using a mimimisation algorithm to balance depression severity and antidepressant use between groups. Treatment was delivered in an out-patient university-based specialist mood disorder clinic. Researcher-blinded assessments were completed at intake and six, 12, and 18 months. Co-primary outcomes were depression (PHQ-9) and wellbeing (Warwick Edinburgh Mental Wellbeing Scale) at 6 months. Primary clinical proof-of-concept analyses were intention to treat. Feasibility (including safety) and health economic analyses used complete case data. This trial is registered at the ISRCTN registry, ISRCTN85278228. Findings: Between 3/29/2017 and 7/31/2018, 82 individuals were recruited (102% of target sample) and 41 individuals were allocated to each arm. A minimum adequate treatment dose was completed by 36/41 (88%) of CBT and 35/41 (85%) of ADepT participants. There were two serious adverse events in each arm (primarily suicide attempts; none of which were judged to be trial- or treatment-related), with no other evidence of harms. Intake and six-month primary outcome data was available for 37/41 (90%) CBT participants and 32/41 (78%) ADepT participants. Between-group effects favoured ADepT over CBT for depression (mean? = -1.35, 95% CI = -3.70, 1.00, d = 0.23) and wellbeing (mean? = 2.64, 95% CI = -1.71, 6.99, d = 0.27). At 18 months, the advantage of ADepT over CBT was preserved and ADepT had a >80% probability of cost-effectiveness. Interpretation: These findings provide proof of concept for ADepT and warrant continuation to definitive trial. Funding: NIHR Career Development Fellowship.
AB - Background: Anhedonia (reduced interest/pleasure) symptoms and wellbeing deficits are core to depression and predict a poor prognosis. Current depression psychotherapies fail to target these features adequately, contributing to sub-optimal outcomes. Augmented Depression Therapy (ADepT) has been developed to target anhedonia and wellbeing. We aimed to establish clinical and economic proof of concept for ADepT and to examine feasibility of a future definitive trial comparing ADepT to Cognitive Behavioural Therapy (CBT). Methods: In this single-centre, open-label, parallel-group, pilot randomised controlled trial, adults meeting diagnostic criteria for a current major depressive episode, scoring =10 on the Patient Health Questionnaire (PHQ-9) and exhibiting anhedonic features (PHQ-9 item 1 = 2) were recruited primarily from high intensity Improving Access to Psychological Therapy (IAPT) service waiting lists in Devon, UK. Participants were randomised to receive 20 sessions of CBT or ADepT, using a mimimisation algorithm to balance depression severity and antidepressant use between groups. Treatment was delivered in an out-patient university-based specialist mood disorder clinic. Researcher-blinded assessments were completed at intake and six, 12, and 18 months. Co-primary outcomes were depression (PHQ-9) and wellbeing (Warwick Edinburgh Mental Wellbeing Scale) at 6 months. Primary clinical proof-of-concept analyses were intention to treat. Feasibility (including safety) and health economic analyses used complete case data. This trial is registered at the ISRCTN registry, ISRCTN85278228. Findings: Between 3/29/2017 and 7/31/2018, 82 individuals were recruited (102% of target sample) and 41 individuals were allocated to each arm. A minimum adequate treatment dose was completed by 36/41 (88%) of CBT and 35/41 (85%) of ADepT participants. There were two serious adverse events in each arm (primarily suicide attempts; none of which were judged to be trial- or treatment-related), with no other evidence of harms. Intake and six-month primary outcome data was available for 37/41 (90%) CBT participants and 32/41 (78%) ADepT participants. Between-group effects favoured ADepT over CBT for depression (mean? = -1.35, 95% CI = -3.70, 1.00, d = 0.23) and wellbeing (mean? = 2.64, 95% CI = -1.71, 6.99, d = 0.27). At 18 months, the advantage of ADepT over CBT was preserved and ADepT had a >80% probability of cost-effectiveness. Interpretation: These findings provide proof of concept for ADepT and warrant continuation to definitive trial. Funding: NIHR Career Development Fellowship.
KW - CBT
KW - Depression anhedonia
KW - Psychotherapy
KW - RCT
KW - Wellbeing
U2 - 10.1016/j.eclinm.2023.102084
DO - 10.1016/j.eclinm.2023.102084
M3 - Article
C2 - 37528846
SN - 2589-5370
VL - 61
JO - EClinicalMedicine
JF - EClinicalMedicine
M1 - 102084
ER -