Participants and setting
We conducted an open, non-controlled trial in community settings in Korangi, a low-income, urban district in Karachi, Pakistan. Patients visiting a primary care centre with integrated mental health service were assessed for depression and anxiety by a lay counsellor and enrolled for a brief intervention utilising a task-sharing approach. Lay counsellors were eligible to participate in the study if they had completed Interactive Research and Development Mental Health Program’s basic counselling training, had more than 6 months experience working with patients and did not plan to leave their position during the study period.
Patients visiting Indus Hospital and Health Network’s primary care center were approached to participate in the study if they met the following criteria: age between 18 and 65 years; resided within 20 km of the center, presented with symptoms of depression and anxiety (based on assessment on Aga Khan University Depression and Anxiety Scale (AKUADS)); and capacity to give informed consent. As the primary outcome was subjective quality of life, patients were excluded if they had a mean score of 5 or higher on the Manchester Short Assessment of Quality of Life (MANSA) scale. Consecutive patients were screened until enrollment was complete. Eligible patients completed a baseline questionnaire and were asked to identify two family members who were willing and interested in taking part in the study. ‘Family’ here is defined as anyone who is close with the patient and provides support. Consenting family members completed a short questionnaire including socio demographic information as well as a short assessment on caregiver burden.
Ethics approval was obtained by the Interactive Research Institutional Review Board (IRB 00005148) and Queen Mary University London Institutional Review Board (QMERC). The trial was retrospectively registered with the ISRCTN registry (ISRCTN12299326) on 5th June 2019.
Materials and instruments
This was a mixed methods study and quantitative and qualitative data was collected. Basic demographics including age, gender, marital status, education status and employment status were collected for all participants.
The primary outcome for this study was subjective quality of life, measured on the MANSA. The MANSA comprises 16 items and patients rate their satisfaction on 12 life domains on a Likert scale from 1 to 7 (completely dissatisfied to completely satisfied). The mean score of these items is taken as indicator of subjective quality of life. The MANSA has been tested and used with patients in community settings .
Secondary outcome measures were the symptoms of depression and anxiety, and social outcomes. The AKUADS  is a locally developed and validated 25-item screening instrument for the symptoms of depression and anxiety. Based on a Likert scale rating of 0–3 for each question, scores range from 0 to 75, with higher scores indicating greater symptom severity. A score of 20 or above indicates probable depression and/or anxiety (Cronbach’s alpha = 0.69). The Social Outcome Index (SIX)  is an objective measure of social outcomes, designed to assess the employment, accommodation and social relationships of people living with mental illness. Scores range from 0 to 6, with higher scores indicating better social outcomes.
The Burden Assessment Scale (BAS)  19 item questionnaire to assess objective and subjective caregiver burden was used to assess caregiver burden, with higher scores indicating higher burden (Cronbach’s alpha = 0.78).
A topic guide was developed for semi-structured interviews with participants in the local language, Urdu to learn about their experience with the intervention, barriers and facilitators to attending intervention sessions, suggested adaptations and the practical delivery of the intervention in the current context.
Patients were recruited between 27 May 2019 and 30 September 2019 and follow-up data was collected between December 2019 and January 2020. Written informed consent was obtained from all counsellors, patients and caregivers. All counsellors participating in the study received a 1-day training on group facilitation and implementation of the family involvement intervention.
The intervention involved monthly meetings of patients, their family members and counsellors to discuss pre-agreed, co-produced topics to allow learning through sharing experiences, mutual support and psychoeducation. At the end of each meeting, a meeting topic for the following meeting was agreed by mutual consensus of the group. Topics chosen by the groups were related to different life domains including relationship management, increasing self-awareness, the importance of physical health, recognizing signs of depression and anxiety, positive thinking, among others. The purpose of the meeting was to provide a safe space for patients and their family members to decide topics of concern, and benefit from communication, learnings, and psychoeducation from each other as well as the mental health facilitator. As such, the groups followed principles of mutual respect but allowed for flexibility so that group members could prioritize discussions around areas that concerned them. The meetings were held once per month over 6 months at local community centers and were chaired by trained counsellors. Each group consisted of five or six patients, one or two family members per patient, and the counsellor. Six multi-family groups were set up for the 6-month period, with each facilitator running two groups. Each family was reimbursed in local currency for travelling to the meeting site. A topic guide was developed in Urdu for semi-structured interviews with a subset of participant patients and service-providers after completion of intervention to learn about their experience with the intervention, barriers and facilitators to attending intervention sessions, suggested adaptations and the practical delivery of the intervention in the current context.
Patients and their families were not involved in setting the research question or the outcome measures, but they were they intimately involved in the co-development of the intervention design and implementation. Patients and family members along with the research team decided the agenda of each meeting.
Quantitative data was analyzed using R software for data analysis. Descriptive statistics of demographic variables are provided with mean and standard deviation and frequencies for categories. Parametric analysis was conducted as assumptions of normality were met for the outcome variables of interest. Paired t-tests were used to assess changes in outcome measures over time. A p-value < 0.05 was considered statistically significant. Effect sizes were calculated for all outcome measures, using Cohen’s guidelines for effect size: 0.2 = small, 0.5 = medium, 0.8 = high .
Qualitative interviews were transcribed verbatim, and an inductive approach was used to provide new insights and richer understanding of the data without using preconceived categories. Two members of the research team (AB and SS) first familiarized themselves with the transcripts and used thematic analysis to examine the data, grouping similar under themes, and the identified themes and sub-themes discussed, checked, and refined by consensus. The transcripts were reviewed line by line by the first and second author independently, and text extraction was used to identify units of analysis and sorted into themes. Each theme was discussed and refined until consensus was reached. Direct quotations from the original transcript were included under each theme, maintaining the terminology used by the participants.