Supported cognitive-behavioural self-help versus treatment-as-usual for depressed informal carers of stroke survivors (CEDArS): study protocol for a feasibility randomized controlled trial

Abstract

Background: Increased life expectancy has resulted in a greater provision of informal care within the community for patients with chronic physical health conditions. Informal carers are at greater risk of poor mental health, with one in three informal carers of stroke survivors experiencing depression. However, currently no psychological treatments tailored to the unique needs of depressed informal carers of stroke survivors exist. Furthermore, informal carers of stroke survivors experience a number of barriers to attending traditional face-to-face psychological services, such as lack of time and the demands of the caring role. The increased flexibility associated with supported cognitive behavioral therapy self-help (CBTsh), such as the ability for support to be provided by telephone, email, or face-to-face, alongside shorter support sessions, may help overcome such barriers to access. CBTsh, tailored to depressed informal carers of stroke survivors may represent an effective and acceptable solution. Methods/Design: This study is a Phase II (feasibility) randomized controlled trial (RCT) following guidance in the MRC Complex Interventions Research Methods Framework. We will randomize a sample of depressed informal carers of stroke survivors to receive CBT self-help supported by mental health paraprofessionals, or treatment-as-usual. Consistent with the objectives of assessing the feasibility of trial design and procedures for a potential larger scale trial we will measure the following outcomes: a) feasibility of patient recruitment (recruitment and refusal rates); (b) feasibility and acceptability of data collection procedures; (c) levels of attrition; (d) likely intervention effect size; (e) variability in number, length and frequency of support sessions estimated to bring about recovery; and (f) acceptability of the intervention. Additionally, we will collect data on the diagnosis of depression, symptoms of depression and anxiety, functional impairment, carer burden, quality of life, and stroke survivor mobility skill, self-care and functional ability, measured at four and six months post-randomization. Discussion: This study will provide important information for the feasibility and design of a Phase III (effectiveness) trial in the future. If the intervention is identified to be feasible, effective, and acceptable, a written CBTsh intervention for informal carers of stroke survivors, supported by mental health paraprofessionals, could represent a cost-effective model of care. Trial registration: Current Controlled Trials ISRCTN63590486. Keywords: Randomized controlled trial, Cognitive behavioral therapy (CBT), Self-help, Depression, Stroke, Informal caregivers