Effectiveness of the Stress Process Model-Based Program in Dementia Caregiving (DeCare-SPM) for Family Caregivers: A Study Protocol for a Randomized Controlled Trial

Figures & data

Figure 1 Theoretical framework of the intervention protocol.

Abbreviations: DeCare-SPM, Stress Process Model-based Program in Dementia Caregiving; IWD, Individuals with Dementia; NPS, Neuropsychiatric Symptoms.

Figure 2 Flow Diagram protocol of study.

Table 1 Intervention Components

DeCare-SPM	Sessions	Goals	Focus Contents
Stressors	Session 1: Being a caregiver	Improve knowledge and skills	1. Focus on primary stressors: Problem-based coping ● Know about dementia (overview, antecedents, consequences, etc.) ● Everyday care (eating, toileting, continence care, etc.) ● Behavior changes (affective symptoms, psychosis, etc.)
	Session 2: Caring for me	Reduce negative feelings	2. Focus on secondary stressors: Emotion-based coping ● Relaxation (deep breathing, progressive muscle relaxation) ● Mindfulness (self-acceptance, mindful life) ● Behavioral activation (sleep, pleasant events)
Appraisal & Coping	Session 3: Finding the meaning of caregiving	Enhance positive feelings	3. Focus on re-appraisal: Meaning-based coping ● Self-care (keep healthy, seek support) ● Benefit finding (source of meaning, power of role models) ● Positive appraisal (mind change, goal setting)
Mediators	Session 4: Supporting for me	Promote social support and maintain intervention efficacy	4. Focus on support network: Supporting caregiver ● Support group (information, resources, etc.) ● Telephone-based consultation (care plan, solutions) ● Boosters (reinforce the whole intervention contents)

Abbreviation: DeCare-SPM, Stress Process Model-based Program in Dementia Caregiving.

Table 2 Study Timelines

Time from Enrollment	Baseline (T0)	1d	2d	3d	1m (T1)	Up to 6m
						3m (T2)	6m (T3)
Intervention
DeCare-SPM	X	S-1	S-2	S-3	Weekly S-4	Monthly S-4
Control group	X	Usual care
Assessment
Demographic information	X
Primary outcome
PACS-9	X				X	X	X
Secondary outcomes
For caregivers	X				X	X	X
For IWD	X				X	X	X
Biomarkers	X				X	X	X
Process evaluation	See Table 3

Abbreviations: DeCare-SPM, Stress Process Model-based Program in Dementia Caregiving; IWD, Individuals with Dementia; S, Session; PACS-9, 9-item positive aspects of caregiving scale.

Table 3 Data Sources and Data Collection Approach

Key Questions	Data Source and Measurement	Measurement Point
Individual characteristics of dementia and family caregivers	CRF- basic information on dementia and family caregiver	T0
Interpersonal relationships	CRF-relationship quality (two items)	T0
Community services	CRF- service utilization (two items)	T0
Healthcare system	CRF- A type of medical insurance	T0
Extent and consistency of intervention delivered	Checklist based on intervention protocol	Immediately after interventions
Participants’ engagement in the intervention	Questionnaire- engagement with interventions (attention, interest, interaction, and performance)	Immediately after interventions
	Attendance records
The extent to which intervention components become part of caregiving	Questionnaire-frequency of practice intervention components	T3
Satisfaction with program	Questionnaire-The client satisfaction questionnaire (CSQ-8)	T2
	Focus-group interview with participants
Recruitment procedure	Screening and follow-up records	T0 – T3
Acceptability, perception of intervention components	Focus-group interview with participants	Immediately after interventions, T2
	Semi-structure interview with project staff
Facilitators and barriers (RE-AIM)	Focus-group interview with participants	T3
	Semi-structured interview with project staff

Abbreviations: CRF, Case Report Form; RE-AIM, Reach, Effectiveness, Adoption, Implementation, Maintenance.

Figure 3 Process evaluation framework.

Abbreviations: DeCare-SPM, Stress Process Model-based Program in Dementia Caregiving; PAC, Positive Aspects of Caregiving.