Wilz 2016a.

Methods	Randomised controlled trial (October 20018‐July 2010)
Participants	Informal caregivers of people with dementia recruited mainly from the areas of Berlin/Brandenburg and Thuringia, Germany. Most of the caregivers were recruited via print media (80%). Some participants learned about the study via the internet (6%), cooperating institutions (5%), relatives and friends (4%), practitioners (2%), television (2%), or radio (1%). Caregivers were included if they had the main responsibility for caregiving for a patient with a diagnosis of Alzheimer’s disease and a Global Deterioration Score > 3 as rated by the screening person based on the caregiver’s report. Caregivers were also required to have no simultaneous psychotherapy, no obvious cognitive impairment (estimated in the comprehensive screening procedure through assessor’s evaluation), and no severe acute mental and/or physical illness. Mean caregiver age was 62.01 years (SD = 9.33) and females comprised 82.2% (n = 157) of the sample. Most were spouses or partners (n = 76, 39.8%) and daughters or daughters‐in law (n = 75, 39.3%) of the care‐recipients. Of the male participants, more partners (n = 21, 11%) than sons or sons‐in‐law (n = 12, 6.3%) were included.
Interventions	Intervention: CBT (n = 50) Aim: To analyse whether caregivers of the intervention group reported better well‐being and health post‐treatment than caregivers of an untreated control group and an attention control group (treated with progressive muscle relaxation (PMR)), and whether these benefits were maintained at 6‐month follow‐up Interventionist(s): Six experienced clinical therapists (Master’s Degree) Mode of delivery: Telephone Duration: 3 months Content: This is a multicomponent intervention focused on managing the behaviour problems and personality changes of the care‐recipient, reduction of social isolation, assisting in utilization of professional and informal support, stress reduction, emotion regulation, reinforcement of positive activities, and supporting acceptance of role change and loss. The intervention included a therapeutic manual consisting of five CBT intervention modules, matched to the needs of the caregivers of people with dementia. Standardisation: Interventionists attended intensive pre‐intervention training with twice‐monthly supervision during the delivery of the intervention, which was carefully monitored based on intervention documentation (date, duration, content) and audiotaping of each session. Comparison group: Untreated control group (n = 50)
Outcomes	1. Psychological health (depression) German version of the 20‐item Center for Epidemiologic Studies Depression Scale (CES‐D). Higher scores indicated greater symptoms of depression. 2. Satisfaction with the intervention: A 5‐point Likert scale (where 1 = very good, 2 = good, 3 = average, 4 = below average, 5 = unsatisfactory). Lower scores indicated greater satisfaction. Data were collected at the end of intervention and at 6 months, the medium‐term follow‐up time point.
Notes	In this study, a second 'selected' non‐randomised experimental group was created where all sessions were delivered by telephone. This non‐randomised arm of the study did not fulfil our inclusion criteria. The study was deemed as meeting our inclusion criteria because the findings from the randomised experimental group were provided by the author. The attention‐only arm was excluded from our review as it was administered over the phone. Funding source: The study was supported by a grant from the German Federal Ministry of Health (LTDEMENZ‐44‐092) (p.43).
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	An independent data management and biometry centre was involved to ensure blinded randomisation. The random number generator Random.org was used for randomisation (p.30).
Allocation concealment (selection bias)	Unclear risk	Insufficient information to assess
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Insufficient information to assess
Blinding of outcome assessment (detection bias) All outcomes	Low risk	An independent data management and biometry centre was involved for blinded assessment (p.30).
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	The experimental group to which the reported loss to follow‐up related was not specified.
Selective reporting (reporting bias)	Low risk	All prespecified outcomes for this review were reported (p.38 and 39).
Other bias	High risk	Significant differences between untreated control group and experimental group in terms of perceived health (p.31)