Change in quality of life scores (measured using the Brief Version WHO-Quality of life tool)
Time frame: Change from baseline to 3 months post-intervention.
The researchers will compare the changes in the mean WHO-QOL scores between the intervention and control arms
Fidelity to the intervention assessed using a researcher designed rating scale
Time frame: until completion of participant recruitment and follow-up, an average of 3 months
Fidelity checklists will be developed based on key elements of the intervention. Items will be rated by the SBI trainers on a 3-point scale.
Study Participation Rate
Time frame: until completion of participant recruitment and follow-up, an average of 3 months
Number of participants who consent to take part in the study divided by the number of eligible patients. The researchers will also document reasons for refusal to participate in the study. Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of those who eligibility meet criteria consent to participate
Proportion of participants meeting inclusion criteria who get excluded
Time frame: until completion of participant recruitment and follow-up, an average of 3 months
Number of participants excluded divided by number meeting inclusion criteria. The researchers will document reasons for exclusion; Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of those meeting inclusion criteria are not excluded
Proportion of participants willing to be randomized
Time frame: until completion of participant recruitment and follow-up, an average of 3 months
Number of participants consenting to participate divided by number willing to be randomized to either study arm; Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of those consenting are willing to be randomized to either study arm
Study Completion Rate
Time frame: Baseline, month 3
Number of participants who complete both the baseline and month 3 assessments/intervention divided by the number of participants enrolled in each study arm; Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% complete both baseline and month 3 assessments
Participant Burden
Time frame: Baseline, month 3
Time required to complete data collection at each assessment time point. Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of participants complete study assessments and the SBI in less than 90 minutes at baseline; and study assessments in less than 60 minutes at month 3
Data Completeness
Time frame: Baseline, month 3
Percentage of questionnaires/study measures completed; Benchmark to establish feasibility for conducting a full-scale randomized trial: 80% of those who enroll will complete at least 80% of study questionnaires/measures