Soellner 2015.

Trial name or title	The Tele.TAnDem intervention: study protocol for a psychotherapeutic intervention for family caregivers of people with dementia
Methods	Non‐blinded two‐armed parallel RCT
Participants	Caregiving partners, children and children‐in‐law who have key responsibility for the relative with at least a low grade dementia diagnosis. Caregivers are excluded if they are in receipt of ongoing psychotherapeutic treatment, have a severe physical illness/medically diagnosed psychiatric disorder or the person with dementia is institutionalised or institutionalisation is planned for the next 6 months.
Interventions	Aim: The primary objective was to evaluate whether telephone‐based cognitive‐behavioural therapy (TEL) improves depressiveness, burden of care, health complaints, and problem‐solving ability compared to usual care. Interventionist(s): Psychotherapists Mode of delivery: Telephone Duration: 6 months (weekly for 4 weeks, two‐weekly for 6 further sessions and monthly for the last two sessions) Title of intervention: Cognitive‐behavioural telephone‐based intervention for family caregivers of people with dementia. Content: The intervention is based on the principles and methods used in cognitive behavioural therapy. Therapy strategies were adapted for caregivers of people with dementia. The intervention which is standardised and manualised consists of 10 different therapy modules individualised by the therapist to the needs of each participant. Standardisation: according to the manual Comparison group: usual care
Outcomes	1. Quality of life using the WHOQoL‐BREF, a standardised and normed questionnaire with 26 items measuring subjective physical and mental well‐being as well as satisfaction with social relations and the environment 2. Burden: A self‐developed thermometer scale (0‐100, vertical) 3. Depression: A self‐developed thermometer scale (0‐100, vertical) and the Allgemeine Depressionsskala (ADS). ADS consists of 20 item covering emotional, motivational, cognitive, and somatic aspects. 4. Physical health: complaints assessed on four domains (fatigue, stomach problems, heart problems, and joint pain) by using the Gießener Beschwerdebogen instrument. 5. Problem‐solving using the Goal Attainment Scaling, a non‐standardised manual‐based instrument providing process‐orientated information on how far participants are from reaching individual therapy goals 6. Anxiety: The anxiety subscale of the Hospital Anxiety and Depression Scale 7. Cost: Cost‐effectiveness analysis will be conducted from the perspective of statutory health insurance with a time horizon of 6 months. This consisted of the costs of the intervention and of the health care utilisation of the caregiving relatives. The latter were assessed by the FIMA questionnaire. Time spent on informal care was measured by a modified version of the Resource Utilisation in Dementia (RUD) questionnaire. Effectiveness was measured using the subjectively rated health status of caregiving relatives and quality of life, measured through the EQ‐5D. Data were collected at T1, end of intervention (6‐month time point) and T2, 12 months (the 6‐month follow‐up time point).
Starting date	Not stated
Contact information	Renate Soellner email:soellner@uni‐hildesheim.de
Notes	Findings for this study were not published at the time of our search.