Clin Psychopharmacol Neurosci.
2022 May;20(2):300-310. 10.9758/cpn.2022.20.2.300.
Mixed Methods Thematic Analysis of a Randomised Controlled Trial of Adjunctive Mitochondrial Agents for Bipolar Depression
- Russell SE
1 - Wrobel AL1,2
- Dean OM1,3
- Berk M1,2,3,4
- Dodd S1,5
- Ng CH4
- Malhi GS6,7,8
- Cotton SM2,5
- Sarris J4,9
- Turner A1,10
- Affiliations
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- 1Deakin University, IMPACT, the Institute for Mental and Physical Health and Clinical Translation, School of Medicine, Barwon Health, Geelong, Australia.
- 2Orygen, The National Centre of Excellence in Youth Mental Health, Parkville, Australia.
- 3Florey Institute for Neuroscience and Mental Health, University of Melbourne, Parkville, Australia.
- 4Department of Psychiatry, University of Melbourne, The Melbourne Clinic, Richmond, Australia.
- 5Centre for Youth Mental Health, The University of Melbourne, Parkville, Australia.
- 6CADE Clinic, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, Australia.
- 7Department of Psychiatry, The University of Sydney, Faculty of Medicine and Health, Northern Clinical School, Sydney, Australia.
- 8Academic Department of Psychiatry, Royal North Shore Hospital, Northern Sydney Local Health District, St Leonards, Australia.
- 9NICM Health Research Institute, Western Sydney University, Westmead, Australia.
- 10School of Medicine and Public Health, Faculty of Health, The University of Newcastle, Callaghan, Australia.
- KMID: 2530465
- DOI: http://doi.org/10.9758/cpn.2022.20.2.300
Abstract
Objective
There is often a shortfall in recovery following treatment for an episode of bipolar disorder (BD). Exploration of participant’s experience provides vital information to enhance statistical outcomes for novel therapy trials. This study used mixed-methods to explore participants’ experience of a trial testing N -acetyl cysteine (NAC) and mitochondrially active nutraceuticals for BD depression.
Methods
Case report forms from a randomised controlled trial (RCT) of BD depression (n = 148) were analysed using a pragmatic adaption of grounded theory and thematic analysis.
Results
Thematic analysis of 148 study participants indicated numerous changes in participant experience over time. For example, perceived environmental stressors reported by participants decreased over the trial in both treatment groups. Quantitative analysis of the themes revealed more positive theme reports in the combination treatment arm compared to the placebo arm and there were more negative themes identified in the placebo arm, compared to the NAC arm.
Conclusion
This approach revealed additional results not elucidated in the primary quantitative analysis. This emphasises the value of mixed-methods research in capturing participants’ experiences in RCTs and detecting possible latent benefits and risks. Such methods can detect latent target signals in novel therapy trials conducted in BD and generate novel hypotheses.
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