Glueckauf 2012.

Methods	Randomised pilot trial (Study start date: October 2008, end date was not reported but final data collection date for primary outcome was February 2012)
Participants	Informal caregivers of people with dementia recruited from 2 memory disorder clinics, the local Alzheimer’s caregiver organisations, local newspapers, and self‐referral based on information from a friend in Jacksonville‐Tallahassee, USA. Caregivers (CGs) were included if they were 18 years of age and older, provided direct care to their care‐recipients (CR) for a minimum of 6 hours per week for at least 6 months, reported specific caregiving problems amenable to change within a 12‐week intervention frame (e.g. increasing CG social and recreational activities and managing effectively CR agitation and aggressive behaviours), scored a minimum of 10 on the Patient Health Questionnaire‐9 indicating a moderate level of depression, and reported no difficulties in hearing over the phone.The caregivers consisted of husbands (n = 1), wives (n = 5), daughters (n = 4), granddaughter (n = 1) of the care‐recipients. Five of the 7 caregivers randomised to the intervention group completed the intervention and 6 of the 7 randomised to the control group completed the study. The mean age of the caregivers who completed the study was 58.09 (SD = 10.11) years and 1 was male and 10 female. All caregivers had an average of 14.18 (SD = 1.78) years education. Care‐recipients: All care‐recipients were African‐Americans with mean age in years 76.73 (SD = 6.60) and education (years) 12.27 (SD = 3.80), independence in activity of daily living mean score of 2.64 (SD = 1.91) and independence in instrumental activities of daily living mean score of 20.36 (SD = 2.46). Care‐recipients were required to have a medical diagnosis of possible Alzheimer’s disease or other type of progressive dementia verified by a physician at a memory disorder clinic approved by the Alzheimer’s Disease Initiative and at least one limitation in basic activities of daily living and 2 dependencies in IADL.
Interventions	Intervention: A cognitive behavioural program (CBT) (group and individual format) (n = 7) Aim: To assess CGs appraisal of the intervention process and its impact on daily caregiving experiences and to conduct a preliminary analysis of the effects of face‐to‐face and telephone‐based CBT on changes in subjective burden, assistance support, depression, and health status in African‐American dementia CGs. Interventionist(s): Four African American counsellors, 3 females and 1 male, and were randomly assigned to the groups. All counsellors had a master’s degree in a counselling related profession and at least 1 year of group intervention experience. All 4 regularly used CBT in their practices but none had participated in a formal CBT workshop prior to the study. Average age of counsellors (66 years, SD = 9.2), average years of education (21.5, SD = 1.29), average years in professional practice (30.75, SD = 13.38). Mode of delivery: Telephone Duration: Twelve, 1‐hr, weekly sessions Content: Telephone‐based CBT took place at the CGs’ homes mediated by either a Florida State University or Mayo Clinic Jacksonville teleconferencing system. The intervention program consisted of seven group and five individual CG goal‐setting and implementation sessions. The small group format was used to encourage discussion and clarification about the rationale for and application of fundamental, cognitive–behavioural skills (e.g. assertiveness and effective thinking), as well as to enhance social support among participants. Individual sessions concentrated on the development of problem‐solving skills, beginning with the identification of key caregiving problems and the performance of focused problem histories, followed by goal setting, rehearsal of goal‐related behaviours, goal implementation, and monitoring change over time. Acquisition of such skills was time‐intensive and required tailoring of the intervention to the specific circumstances, characteristics and preferences of the CG, thus necessitating a one‐on‐one format. All participants received a CBT guidebook and a copy of The 36 Hour Day, and information about local dementia care resources prior to the first training session. Standardisation: Interventionist training consisted of two 6‐hour training workshops performed over a period of 2 months by two of the authors who were doctoral‐level licensed clinicians. The authors concluded that overall findings of treatment fidelity analysis suggested that pilot counsellors adhered to implementation guidelines in conducting the CBT program. Comparison group: Face‐to‐face CBT was performed at a university‐based conference room or in a private, soundproof room at a public library. The structure and contents of the programme were the same as that for the telephone intervention (n = 7).
Outcomes	1. Burden: The subjective burden scale of the Caregiver Appraisal Inventory – a subscale of the Caregiver Appraisal Inventory (CAI). Higher scores indicated greater burden. 2. Psychological health (depression): Center for Epidemiological Studies Survey‐Depression scale (CES‐D) is a 20‐item self‐report scale that assesses depression in non‐clinical community populations. Respondents rate the frequency of a variety of depressive symptoms they have experienced over the past week on a 0 to 3 scale. A total score ranging from 0 to 60 is derived by summing the item scores. Individuals scoring 16 or higher on the CES‐D are generally considered to be at risk for developing clinical depression. 3. Psychological health (stress): The Revised Memory and Behaviour Problem Checklist (RMBPC) ‐ The disruptive behaviour and depression subscales (17 items) measure CG distress associated with CR disruptive behaviours and CR difficulties with depression. Higher scores indicated higher levels of stress. 4. Health status and well‐being (physical health): Physical symptoms subscale of the modified Caregiver Health and Behaviour inventory (CHHB). The modified CG Health and Health Behaviors inventory (CHHB) is a 42‐item scale to assess dementia CG perceived health, sleep quality, unhealthy behaviours, chronic health conditions, and physical symptoms. Two items ask respondents to rate their general health; two items measure quality of sleep; four items assess involvement in unhealthy behaviours such as smoking and drinking alcohol to excess; 15 items assess the presence of CG health problems, such as high blood pressure, diabetes, cancer, and arthritis; and 21 items measure physical symptoms, such as headaches, shortness of breath, heartburn, and sore throat. Higher scores indicated greater physical ill‐health. Outcome data were collected via the telephone at the end of intervention, approximately 1 week after the 12 week CBT program.
Notes	Funding source: Grants from the National Institute of Mental Health (R34MH078999) Florida State University College of Medicine, and University of South Florida Health Byrd Alzheimer’s Institute (p.124). Unpublished data sought via email but not received, author did provide information to enable categorisation of the study during the data screening process.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	Insufficient information to assess
Allocation concealment (selection bias)	Unclear risk	Insufficient information to assess
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Unable to blind due to nature of the intervention
Blinding of outcome assessment (detection bias) All outcomes	Low risk	"Post treatment assessments were also administered over the telephone by an independent interviewer..." (p.130). "The interviewer was unaware of assignment to treatment condition" (p.130) .
Incomplete outcome data (attrition bias) All outcomes	Low risk	Minimal attrition (3:1 intervention and control) and reasons provided, p.133
Selective reporting (reporting bias)	High risk	Results for stress not reported (p.134)
Other bias	Low risk	Groups fairly balanced on all baseline characteristics and measures, although Jacksonville CRs had a significantly greater number of years of education than their Tallahassee counterparts (p.134).