| Literature DB >> 32698802 |
A S J van der Watt1, W Odendaal2,3, K Louw2, S Seedat2.
Abstract
BACKGROUND: Broadening our knowledge of the longitudinal course of mood symptoms is cardinal to providing effective long-term treatments. Research indicates that patients with mental illness are willing to engage in the use of telemonitoring and mobile technology to assess and monitor their mood states. However, without the provision of distant support, adverse outcomes and events may be difficult to prevent and manage through self-monitoring. Understanding patient perspectives is important to achieving the best balance of self-monitoring, patient empowerment, and distant supporter involvement.Entities:
Keywords: Affective disorder; Distant; Intervention; LMIC; Monitoring; Mood disorder; South Africa; Task-shifting
Mesh:
Year: 2020 PMID: 32698802 PMCID: PMC7374077 DOI: 10.1186/s12888-020-02782-y
Source DB: PubMed Journal: BMC Psychiatry ISSN: 1471-244X Impact factor: 3.630
Fig. 1Screening process
Description of study design and monitoring procedures
| Authors | Study Design | Sample Characteristics (Population and Comparison) | Mood Monitoring Information (Intervention and Time) | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Mood Disorder | Sample Size | Mean Age (Range; SD) | Monitoring | Feedback | Frequency | Total Length (weeks) | Start of monitoring | ||
| RCT single blind | BD | Intervention: Placebo-control group provided with mobile phone for daily use: | Intervention: 29.1 (NS; 7.5 years) Control: 29.5 (NS; 9.4 years) | Smart phone application (MONARCA) | Contacted by nurse when necessary; graphic visualization | Daily | 24 | NS: Outpatient population | |
| Single arm observational | MDD | 35.9 (NS; 10.8 years) | Online (Daybuilder webpage) | Telephonic, weekly; graphic visualization | Twice, daily | 4 | NS | ||
| Assessor-blind cluster RCT | MDD | Intervention: EUC control: | Intervention: 15.2 (NS; 1.5 years EUC control: 15.6 (NS; 1.7 years) | Telephonic | Telephonic | At weeks 1, 2, 3, 6, 9 | 12 | NS | |
| Observational | Depressive Disorder | NSb (21–66+ years; NS) | IVR calling system | Clinical teams with actionable feedback and informal caregivers with feedback. | Week 1–6: Weekly with option to reduce to monthly if depression scores were mild enough. Can revert back to weekly at any time. | 21–48 (median = 25) | NS | ||
| RCT | Minor Depression | Intervention: TAU control: | Intervention: 59.8 (NS; 14.6 years) Control: 58.5 (NS; 17.7 years) | Telephonic | Telephonic | Weekly | 8 | NS: Outpatient population | |
| Mixed-method | MDD and BD | Interviews: | Interviews: 35.76 (18–53; 10.8 years) | Telephonic | Telephonic | Weekly | 26 | 1 week post-discharge | |
| Longitudinal | MDD and BD | 35.3 (18–53; 10.2 years) | Telephonic | Telephonic | Weekly | 26 | 1 week post-discharge | ||
| Non-randomised controlled trial | MDD | Intervention: Control: | Intervention: 46.6 (18–65+; 15.0 years) Control: 45.3 (18–65+; 15.4 years) | Telephonic (COMET) | Telephonic | Intervention: Monthly Control: At 3 and 6 months | 24 | Following diagnosis by physician | |
| Observational | BD | 48.67 (NS; 9.63 years). | Telephonic (BiAffect) | Telephonic | Weekly | 8 | NS | ||
AD Anxiety Disorder, BD Bipolar Disorder, COMET Clinical Outcomes in Measurement-based Treatment, EUC Enhanced Usual Care, IVR Interactive Voice Response, MDD Major Depressive Disorder, NS Not specified, RCT Randomized Controlled Trial, TAU Treatment As Usual
aDemographic data only presented for participants who completed the study
bThere were a broad range of ages, with 31% being 21 to 45 years old and 12% being 66 years or older
Description of outcome measures, effectiveness, adverse events, and completion rates
| Authors | Primary Outcome Measures (Comparison and Outcome) | Feasibility and Effectiveness (Outcome) | ||||
|---|---|---|---|---|---|---|
| Depression scale/instrument | Mania | Frequency | Adverse events reported | Completion Rate | Effective | |
| HAMD-17 | YMRS | Monthly for 6 months | Trained nurse contacted participant if deterioration in symptoms detected. Results NS | Intervention: 33/39 = 82.62% Control: 34/39 = 87.18% | No significant improvement in HAMD-17 or YMRS scores. | |
| HAMD-17; MINI; MDI | NA | Baseline; at 4 weeks | 5 participants were readmitted to an inpatient ward due to worsening depression (self-monitoring continued) | General: 34/45 = 76% | 59% of participants believed that the system could detect a relapse, 50% believed that the system could influence the course of their illness, and 50% felt that the system had covered their needs for self-monitoring. No significant improvement in self-assessed mood scores. Significant improvement in HAMD-17 and MDI scores. | |
| BDI | NA | Baseline; at 12 weeks | NS | Intervention: 65/65 = 100% EUC control: 73/78 = 83.49% | Participants rated the intervention as 6/7 (88.57%) in terms of both usefulness and comfort. Clinicians rated the intervention for usefulness for clinical work (90%), usefulness for patients (92.86%), and comfort (85.71%). No significant differences were observed across arms at 12-week follow-up in terms of depressive symptomology. However, regression analysis indicated (i) for each extra point in baseline BDI scores, a reduction of 0.5 points in BDI scores at 12 weeks; and (ii) for each additional point in satisfaction with the psychological care received, a reduction of 4.3 points in BDI scores at 12 weeks. | |
| PHQ-9 | NA | Week 1–6: Weekly with option to reduce to monthly if depression scores were mild enough. Could revert to weekly at any time. | Alerts generated for suicidal ideation, poor medication adherence, and increased depressive symptom severity. Alerts were triggered at a rate of 4.9 per 100 person-weeks of participation. | 11% attrition in first 6 months; 68% assessment completion | NS | |
| PHQ; MINI | NA | Baseline; at 6 months | Participants (37.7%) referred to the behavioural health specialist. | Intervention: 96/130 = 73.85% Control: 72/93 = 77.42% | Intervention group had less (not significantly) depression symptoms and diagnoses at 6-months follow-up than control group. | |
| QIDS | ASRM | Weekly for 26 weeks | Participants reported negative (10.8%) and apprehensive (16.2%) experience of baseline assessment. | Interviews conducted regarding effectiveness: 60.7% | Majority of participants interviewed (86.5%) reported that they found the mood monitoring helpful. | |
| QIDS | ASRM | Weekly for 26 weeks | NS | 45.9% | Significant improvement in QIDS scores. No significant difference in ASRM scores. | |
| PHQ-9; PGI-S | NA | Monthly | Physicians were sent reports on participants’ PHQ scores. 273 PHQ-9 responses endorsing thoughts of self-harm were reported to physicians. | Intervention: 364/503 = 72.37% Control: 278/412 = 67.48% | 45% achieved remission by the end of the study, with the intervention group being significantly more likely to achieve remission. 53.9% fulfilled the response criterion (50% + reduction in PHQ-9 scores), with the intervention group being significantly more likely to achieve response. | |
| HAMD-17 | YMRS | Weekly | NS | Participation varied in terms of the number of weeks that had any keyboard activity, with an average of 4.69 (3.05) weeks. Only 9 participants (9/16 = 56.25%) complete at least 4 weeks. | Decrease in HAMD-17 scores: Week 1 = 11.90 (3.17); Week 8 = 11.11 (5.49). Significance not reported. Decrease in YMRS scores: Week 1 = 7.56 (5.00); Week 8 = 6.67 (4.03). Significance not indicated. | |
ASRM Altman Self-Rating Mania Scale, BDI Beck Depression Inventory, HAMD-17 Hamilton Depression rating scale, MDI Major Depression Inventory, MINI Mini-International Neuropsychiatric Interview, NA Not Applicable, NS Not Specified, PGI-S Patient Global Impression Severity, PHQ Personal Health Questionnaire, QIDS Quick Inventory of Depressive Symptomatology, YMRS Young Mania Rating Scale
aDemographic data only presented for participants who completed the study
bDemographic data only presented for participants who completed the study
cDemographic data only presented for participants who completed the study
MMAP quality appraisal of included articles
| 1. | Yes: Patients suffering from MDD were recruited to participate post discharge. The authors acknowledge that patients referred to the facility may belong to a more severely depressed subset of inpatients. | No: The included participants were not representative of the target population in terms of race, sex, and education. | Yes: Inpatients with a primary mood or anxiety disorder were recruited pre-discharge. | Partially: Participants were recruited based on a physician’s diagnosis of MDD. The authors acknowledge the influence physician selection bias and that standard diagnostic criteria of patients may not have been met. | Partially: Patients suffering from bipolar disorder were recruited to participate in the study. The authors acknowledge that the sample is not representative of the target population in terms of sex. |
| 2. | Yes: The intervention involved monitoring mood and quality of sleep, daily, using a Visual Analog Scale (VAS). Depression outcome was measured using the well-established HAM-D-17 measure. | Yes: The intervention involved monitoring mood and medication adherence using Interactive Voice Response (IVR) technology. Depression outcome was measured using the well-established PHQ-9. | Yes: The intervention involved interepisodal telephonic mood monitoring and the outcomes were measured weekly for 26 weeks using established tools, the ASRM and QIDS. | Yes: The intervention involved monthly telephonic monitoring of depression symptom severity using the well-established PHQ-9. | Partially: The intervention involved weekly telephonic mood monitoring using well-established measures (HAM-D-17; YMRS) and ecological monitoring using keystroke data. The use of keystroke data as indicators of mood symptoms is partially motivated in the introduction section; yet well-established evidence is lacking. |
| 3. | Yes: Mood, sleep, and activity outcomes were analysed using available data from all included patients. The completion rate is relatively high (76%) and the authors clearly indicate the reasons for attrition. Outcome data is reported for all measurements used. | Yes: Mood and medication adherence were analysed using available data from all included participants. Reasons for attrition were not provided. | Yes: Although the drop-out rate was quite high, results showed a significant decline in depression scores. ASRM scores were not indicative of significant mania and the authors also reported data for suicidality. | No: In both the intervention and control group, data were excluded from analysis due to the lack of an interview at 6 months or a too low PHQ-9 score at baseline. | Partially: Missing data were handled with pairwise deletion. |
| 4. | Partially: Analyses model of mood included time, sleep-onset, sleep-offset, sleep quality, activity, and interactions between sleep-onset and day, sleep-offset and day, sleep quality and day, and activity and day. The authors acknowledged confounders that may have had an influence on the data, was not included in the present study data. | Partially: Analyses of completion rates controlled for demographic characteristics, measures of baseline vulnerability, baseline depression scores, and weeks of follow-up. No other confounders are mentioned. | Partially: The authors collected data on traumatic childhood experiences but did not state if these were accounted for as confounders in the data analysis. No other confounders are mentioned. | Partially: Covariates to control for patient demographics and clinical history were included in the logistic regression models. The authors acknowledge that may have had an influence on the data, was not included in the present study data. | No: Possible confounders were not clearly identified, or how they were controlled for. |
| 5. | Yes: The intervention was administered as intended. | Yes: The intervention was administered as intended. | Yes: The intervention was administered as intended. | Yes: The intervention was administered as intended | Yes: The intervention was administered as intended |
| 1. | Yes: Participants were randomized with a balanced ration of 1:1 to receive either an intervention Android smartphone (the intervention group) or a control Android smartphone (the control group) for a 6-month trial period. | Yes: Randomization was conducted using computer-generated random numbers | Unclear: Consented clinicians were randomly assigned to either usual care or close monitoring. Randomization was stratified by clinic. However, it is unclear how participants were randomized. | 1. | No: There is no rationale provided |
| 2. | Yes: Randomization was stratified on age (< 29 or ≥ 29 years) and former hospitalization (yes/no) since these were considered to be possible prognostic variables, and a fixed block size of 10 within each stratum was used. | Yes: Participants’ baseline sociodemographic characteristics were similar, with the exception of socioeconomic status ( | Partial: See Table | 2. | Yes: The qualitative and quantitative components complement each other and function well as a unified whole to answer the research question. |
| 3. | Yes: 82.62% of the intervention group data, and 87.18% of the control group data could be analysed. | Yes: It appears as if all the data mentioned in the measurement section is reported | Yes: 72.31% of the intervention group data, and 77.42% of the control group data could be analysed. | 3. | Yes: The qualitative component provides detailed evidence for acceptability and perceived effectiveness of mood monitoring and reasons for participant drop-out. This information is effectively supported by quantitative data including baseline assessment and post-discharge assessment using established questionnaires. |
| 4. | Partially: Due to the type of intervention, this trial was single-blinded since blinding of the participants, the clinicians, and the study nurse handling the intervention was not possible. | Yes: Patient baseline data and outcomes at 12-week follow-up were evaluated via telephone by a trained consultant who was blinded to treatment allocation. | No: Due to the nature of the intervention, blinding was not possible. | 4. | Unclear: There appears to be no mention of any divergence or inconsistencies between quantitative and qualitative results. |
| 5. | Yes: A total of 3.7% of participant visits were missing (3.6% in the intervention group and 3.8% in the control group) due to participants not attending. | Partially: No participants assigned to the intervention were lost to follow-up. However, only one-third of the patients displayed an adequate adherence to the pharmacological treatment | Unclear: Follow-up data is reported for 75.3% (6 months) for the participants in general. However, it is not clear how many completed the weekly assessments. | 5. | Yes: It is reflected in the analysis and reporting of the data. |
ASRM Altman Self-Rating Mania scale, HAM-D-17 Hamilton Depression rating scale, MDD Major Depressive Disorder, PHQ Patient Health Questionnaire