title: E-care 4 caregivers - an online intervention for nonprofessional caregivers of patients with depression: study protocol for a pilot randomized controlled trial.
abstract: BACKGROUND
  Nonprofessional caregivers are highly important in the everyday life of patients with depression. Yet, they may experience increased levels of burden, stress, depression, and anxiety. Therefore, there is a need for interventions that relieve symptoms and are accessible and time-efficient. This paper describes the protocol of a pilot study to evaluate (1) the feasibility of an online self-management intervention, E-care 4 caregivers, for the nonprofessional caregiver of patients with depression, and (2) the initial effects of E-care 4 caregivers on psychological distress, subjective burden, symptoms of anxiety and depression, and quality of life.
  
  
  METHODS
  The study is a randomized controlled trial in which we are comparing the E-care 4 caregivers online intervention with a wait list control group. Eighty-four nonprofessional caregivers of patients with depression aged 18 years or older are being recruited from among the general population. Feasibility is determined by semistructured telephone interviews evaluating the subjects' satisfaction with the intervention and by using a questionnaire on the user-friendliness of the system. The primary outcome measure used to examine the initial effects of the intervention is psychological distress. Secondary outcome measures are subjective burden, symptoms of anxiety and depression, level of mastery, and quality of life. Assessments will be done at baseline and 6 weeks later. Statistical analysis of the effects of the intervention will be carried out on the basis of the intention-to-treat principle.
  
  
  CONCLUSIONS
  E-care 4 caregivers could potentially benefit nonprofessional caregivers, as well as patients and professionals indirectly.
  
  
  BACKGROUND
  Netherlands Trial Register identifier: NTR5268 . Registered on 30 June 2015.
authors.affiliation: Department of Clinical Psychology, Faculty of Movement and Behavioral Sciences, Vrije Universiteit Amsterdam, van der Boechorststraat 1, 1081 BT, Amsterdam, the Netherlands. l.bijker@vu.nl.|EMGO+ Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands. l.bijker@vu.nl.
authors.forename: L
authors.initials: L
authors.lastname: Bijker
authors.affiliation: Department of Clinical Psychology, Faculty of Movement and Behavioral Sciences, Vrije Universiteit Amsterdam, van der Boechorststraat 1, 1081 BT, Amsterdam, the Netherlands.|EMGO+ Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands.
authors.forename: A
authors.initials: A
authors.lastname: Kleiboer
authors.affiliation: Department of Clinical Psychology, Faculty of Movement and Behavioral Sciences, Vrije Universiteit Amsterdam, van der Boechorststraat 1, 1081 BT, Amsterdam, the Netherlands.|EMGO+ Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands.
authors.forename: H
authors.initials: H
authors.lastname: Riper
authors.affiliation: Department of Clinical Psychology, Faculty of Movement and Behavioral Sciences, Vrije Universiteit Amsterdam, van der Boechorststraat 1, 1081 BT, Amsterdam, the Netherlands.|EMGO+ Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands.
authors.forename: P
authors.initials: P
authors.lastname: Cuijpers
authors.affiliation: Department of Clinical Psychology, Faculty of Movement and Behavioral Sciences, Vrije Universiteit Amsterdam, van der Boechorststraat 1, 1081 BT, Amsterdam, the Netherlands.|EMGO+ Institute for Health and Care Research, VU University Medical Center, Van der Boechorststraat 7, 1081 BT, Amsterdam, the Netherlands.
authors.forename: T
authors.initials: T
authors.lastname: Donker
mesh_terms: D001292:Attitude to Computers; D017028:Caregivers / Q000523:psychology*; D002985:Clinical Protocols; D017281:Cost of Illness; D003863:Depression / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D005240:Feasibility Studies; D006801:Humans; D057194:Intention to Treat Analysis; D020407:Internet; D009426:Netherlands; D017060:Patient Satisfaction; D010865:Pilot Projects; D012107:Research Design; D013315:Stress, Psychological / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D011795:Surveys and Questionnaires; D017216:Telemedicine; D013813:Therapy, Computer-Assisted; D013997:Time Factors; D016896:Treatment Outcome
keywords: Burden; Caregivers; Depression; E-mental health; Feasibility; Pilot study; Prevention; Psychological distress; Randomized controlled trial