Ecological Momentary Intervention for Depressive Symptoms in a Community Sample in Hong Kong

Depressive Symptoms Clinical Trial

Official title:

Ecological Momentary Intervention for Depressive Symptoms in a Community Sample in Hong Kong: a Randomised Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04985422
• Other study ID #: Flow EMI - Depressive Symptom
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: Eric YH Chen, MA
• Phone: (+852) 22554486
• Email: eyhchen.hk[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The key aim of the study is to test the efficacy of a 4-week ecological momentary intervention (EMI), as compared with the regular weekly-based intervention (control group), in reducing (1) symptoms of depression and (2) rumination in community-dwelling individuals. The efficacy of the EMI in reducing distress and improving functioning is also examined. For both EMI and control groups, the intervention will be delivered through SMS text messages, with a link to a user-friendly and locally-adapted intervention platform designed using Qualtrics (online survey programme). It is hypothesised that (1) those in the EMI group, as compared to the control group, will show greater reductions in (1) depressive symptoms, (2) rumination level, (3) distress, and in (4) improving functioning. These effects are hypothesised to be observed in individuals with varying levels of symptom severity.

Description:

Despite the growth of online-based interventions, there remains a lack of highly adaptive and personalised smartphone-based interventions that can be implemented in the course of everyday life. The current study examines the effectiveness of a newly-developed smartphone-based ecological momentary intervention (EMI) in reducing symptoms of depression as well as rumination and distress. Rumination is a common experience in individuals with major depressive disorder (MDD). These psychopathological symptoms occur in a population on a continuous spectrum, which may be especially pronounced after the community has experienced a series of highly stressful and traumatic events. On the high end of the spectrum, manifestations of symptoms may be considered to be clinical disorders, and professional intervention may be indicated. Rumination may affect prognosis and there are suggestions that interventions to reduce and modify rumination can improve outcomes. At the less severe end of the spectrum (i.e., not yet reached the threshold for disorders), rumination may be a risk factor that compromises outcomes and adjustment, one that can cause significant distress and functional impairment. Targeting rumination in both below- and above- threshold populations therefore has important research and clinical implications. Mental Health Needs in Hong Kong The Hong Kong population has undergone a series of highly stressful events traceable since June 2019, from large-scale social unrest, to the outbreak of Coronavirus disease 2019 (COVID-19) first in January 2020 and a second wave of COVID-19 cases in March 2020. Each of these population-level events is accompanied by other related social, economic, and political consequences, all of which can result in significant psychological distress and mental health burdens especially when added up to individual-level stressors. Local studies have reported heightened depressive symptoms in relation to such population-level events in addition to personal stressful events. The rates observed are considerably higher than the average global prevalence, which marks it as particularly concerning when help-seeking is severely minimal in the general local population. It is anticipated that these rates will continue rising and would manifest with symptoms of other conditions (such as anxiety, as is already seen in China during COVID-19). Unsurprisingly, the widespread pandemic has already led researchers in many other countries to call for enhanced and novel psychological interventions. A local online self-help initiative has recently been launched by the Department of Psychiatry of the University of Hong Kong, offered to individuals via different channels (including various social media platforms, non-governmental organisations, social and personal connections) in the form of an anonymous mental health recognition and support tool. The key aims of the tool are to provide users with a space to reflect on the ongoing events in their lives and their feelings, provide them with an individualised understanding of their current mental health conditions (MDD symptoms) and the potential contributing factors, as well as offer individualised suggestions for self-help and professional help when necessary. A high level of MDD as well as significant levels of rumination in response to the community stressors have been reported, particularly in young people. Of importance, rumination about such large-scale external events ("event-based rumination") was seen to be highly associated with MDD symptoms. Rumination and its Consequences In the presence of significant external stressors, an excessive level of symptoms, together with rumination about the stressors or their psychological responses characterise a state described as adjustment disorder (AjD) in the International Classification of Diseases, 11th Revision (ICD-11). The presence of AjD carries an increased level of risk for transition into other clinical disorders, such as MDD. The role of rumination as a mechanism that predisposes individuals towards the development of major depressive episodes has been well studied. Researchers have shown that particular types of rumination, such as brooding (i.e., passive and judgmental comparison of current situation and an unachieved alternative outcome), are specifically responsible for the development of depression. The presence of this rumination type for people with MDD also predicted poorer outcomes. Because of its importance, interventional strategies (such as cognitive-behavioural therapy, CBT) targeting rumination have been developed and have been shown to be effective in improving mental health outcomes. Rumination-focused CBT generally involves increasing one's ability to become aware of their own (brooding) ruminations and supporting them to eventually replace them with alternative thinking habits). Ecological Momentary Assessment and Intervention Recent years have seen the growth of a new avenue for mental health that appears highly suitable for the Hong Kong population, namely ecological momentary assessment (EMA) and ecological momentary intervention (EMI). These mobile health (mHealth) approaches offered new opportunities for mental health research, management, detection, and intervention via smartphones. In EMA, individuals can self-initiate assessments when an emotion or specific event is experienced (event-sampling), or are prompted several times a day to complete brief assessments over a number of days (time-sampling). While EMIs have been used to augment usual treatments, EMIs have also been coupled with EMA to deliver interventions based on symptoms reported in the moment. The essence of these two approaches is their abilities to be implemented in real-time and in everyday life contexts, be designed flexibly according to specific objectives, and be adapted to individual needs. Capturing prospective information on interactions between micro-level experiences and real-world contexts, as well as providing in-the-moment interventions, EMA and EMI impart benefits that cannot be achieved in traditional in-person treatments. Importantly, increasing evidence from randomised controlled trials (RCTs) has shown EMI to be an efficacious and effective means to augment interventions in different disorders, including depression, anxiety, bipolar disorders, psychosis. Furthermore, although EMA in addition to treatment-as-usual (TAU) has shown to be more effective than TAU alone in reducing depressive symptoms in patients with MDD, the positive impact of EMI was shown to be more long-lasting in the EMI+TAU group compared with EMI+TAU, with the effects lasting for up to 3 months for EMA+TAU, and up to 6 months for EMI+TAU. The Current Study EMI appears to be a promising approach to support individuals with distress in the Hong Kong population in reducing symptoms and ruminative thoughts. This is also possibly the only means to reach those less motivated to seek help due to stigma, as well as potential worries over in-person contacts especially after the COVID-19 outbreak. The key aim of the study is to test the efficacy of a 4-week ecological momentary intervention (EMI), as compared with the regular weekly-based intervention (control group), in reducing (1) symptoms of depression and (2) rumination in community-dwelling individuals. The efficacy of the EMI in reducing distress and improving functioning is also examined. It is hypothesised that (1) those in the EMI group, as compared to the control group, will show greater reductions in (1) depressive symptoms, (2) rumination level, (3) distress, and in (4) improving functioning. These effects are hypothesised to be observed in individuals with varying levels of symptom severity.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 262
• Est. completion date: December 31, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 64 Years

Eligibility

Inclusion Criteria:

• Symptoms of depression indicated by DASS-D score of 10 or above
• Aged 15 to 64 years (parental or guardian consent is required for those below 18 years)
• Possess a smartphone with access to the Internet

Exclusion Criteria:

• Significant developmental disorder, psychotic disorder, substance abuse or organic brain disorder
• Active suicidal risk
• Receiving active structured intervention or anticipating to receive such treatment (e.g., biweekly psychotherapy sessions, receiving pharmacotherapy)

Related Conditions & MeSH terms

• Depression
• Depressive Symptoms

Intervention

Behavioral:
• Smartphone-based Daily Ecological Momentary Intervention
Interventions are delivered through smartphones (SMS text message + Qualtrics) at a low cost with high accessibility. Participants are prompted 6 random times a day over the set intervention period (4 weeks) to complete brief EMA and EMI intervention actions) across contexts in daily lives for the reduction of depressive symptoms, as well as rumination distress, and improve functioning.
• Smartphone-based Weekly-delivered Information
Information with simple actions for reducing depressive symptoms are delivered through smartphones (SMS text message + Qualtrics) at a low cost with high accessibility. Participants are prompted weekly with a new set of information, together with a 5-min assessment. The information includes intervention actions provided in the EMI group.

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (12)

Echiverri AM, Jaeger JJ, Chen JA, Moore SA, Zoellner LA. "Dwelling in the Past": The Role of Rumination in the Treatment of Posttraumatic Stress Disorder. Cogn Behav Pract. 2011 Aug;18(3):338-349. doi: 10.1016/j.cbpra.2010.05.008. — View Citation

Kramer I, Simons CJ, Hartmann JA, Menne-Lothmann C, Viechtbauer W, Peeters F, Schruers K, van Bemmel AL, Myin-Germeys I, Delespaul P, van Os J, Wichers M. A therapeutic application of the experience sampling method in the treatment of depression: a randomized controlled trial. World Psychiatry. 2014 Feb;13(1):68-77. doi: 10.1002/wps.20090. — View Citation

Lam LC, Chan WC, Wong CS, Chen EY, Ng RM, Lee EH, Chang WC, Hung SF, Cheung EF, Sham PC, Chiu HF, Lam M, Chiang TP, van Os J, Lau JT, Lewis G, Bebbington P; Hong Kong Mental Morbidity Survey Team. The Hong Kong mental morbidity survey: background and study design. East Asian Arch Psychiatry. 2014 Mar;24(1):30-6. — View Citation

Myin-Germeys I, Kasanova Z, Vaessen T, Vachon H, Kirtley O, Viechtbauer W, Reininghaus U. Experience sampling methodology in mental health research: new insights and technical developments. World Psychiatry. 2018 Jun;17(2):123-132. doi: 10.1002/wps.20513. — View Citation

Ni MY, Yao XI, Leung KSM, Yau C, Leung CMC, Lun P, Flores FP, Chang WC, Cowling BJ, Leung GM. Depression and post-traumatic stress during major social unrest in Hong Kong: a 10-year prospective cohort study. Lancet. 2020 Jan 25;395(10220):273-284. doi: 10.1016/S0140-6736(19)33160-5. Epub 2020 Jan 9. — View Citation

Nolen-Hoeksema S, Wisco BE, Lyubomirsky S. Rethinking Rumination. Perspect Psychol Sci. 2008 Sep;3(5):400-24. doi: 10.1111/j.1745-6924.2008.00088.x. — View Citation

Wang C, Pan R, Wan X, Tan Y, Xu L, Ho CS, Ho RC. Immediate Psychological Responses and Associated Factors during the Initial Stage of the 2019 Coronavirus Disease (COVID-19) Epidemic among the General Population in China. Int J Environ Res Public Health. 2020 Mar 6;17(5):1729. doi: 10.3390/ijerph17051729. — View Citation

Watkins ER. Constructive and unconstructive repetitive thought. Psychol Bull. 2008 Mar;134(2):163-206. doi: 10.1037/0033-2909.134.2.163. — View Citation

Wind TR, Rijkeboer M, Andersson G, Riper H. The COVID-19 pandemic: The 'black swan' for mental health care and a turning point for e-health. Internet Interv. 2020 Apr;20:100317. doi: 10.1016/j.invent.2020.100317. Epub 2020 Mar 19. No abstract available. — View Citation

Wong SM, Hui CL, Wong CS, Suen YN, Chan SK, Lee EH, Chang WC, Chen EY. Prospective prediction of PTSD and depressive symptoms during social unrest and COVID-19 using a brief online tool. Psychiatry Res. 2021 Apr;298:113773. doi: 10.1016/j.psychres.2021.113773. Epub 2021 Jan 29. — View Citation

Wong SMY, Hui CLM, Wong CSM, Suen YN, Chan SKW, Lee EHM, Chang WC, Chen EYH. Mental Health Risks after Repeated Exposure to Multiple Stressful Events during Ongoing Social Unrest and Pandemic in Hong Kong: The Role of Rumination: Risques pour la sante mentale apres une exposition repetee a de multiples evenements stressants d'agitation sociale durable et de pandemie a Hong Kong: le role de la rumination. Can J Psychiatry. 2021 Jun;66(6):577-585. doi: 10.1177/0706743720979920. Epub 2020 Dec 15. — View Citation

Wong SMY, Hui CLM, Wong CSM, Suen YN, Chan SKW, Lee EHM, Chang WC, Wong GHY, Chen EYH. Induced ideas of reference during social unrest and pandemic in Hong Kong. Schizophr Res. 2021 Mar;229:46-52. doi: 10.1016/j.schres.2021.01.027. Epub 2021 Feb 19. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in depressive symptoms, as assessed using the Depression subscale of the Depression, Anxiety and Stress Scales (DASS-D)	The DASS-D is a 7-item measure rated on a 4-point Likert scale. Scores range from 0 to 42, where a higher score represents a higher level of depressive symptoms. The DASS-D has been validated in Hong Kong (epidemiological and clinical samples) as well as in both young people and adults.	Immediately after intervention (post 4-week intervention) and up to 3 months
Secondary	Change in rumination level, as assessed using the 10-item ruminative response scale (RRS-10)	The RRS-10 is a 10-item measure rated on a 4-point Likert scale. Scores range from 10 to 40, where a higher score represents a higher level of ruminative experience.	Immediately after intervention (post 4-week intervention) and up to 3 months
Secondary	Change in psychological distress, as assessed using the Kessler Psychological Distress Scale (K6)	The K6 is a 6-item measure rated on a 5-point Likert scale. Scores range from 0 to 24, where a higher score represents a higher level of distress symptoms.	Immediately after intervention (post 4-week intervention) and up to 3 months
Secondary	Change in level of functioning, as reflected by presenteeism and absenteeism due to distress	Presenteeism is assessed using an item that asks the number of days during the past four weeks the participant has to cut down on work, study, or manage day-to-day activities due to distress. Absenteeism is assessed using an item that asks the number of days during the past four weeks the participant has been totally unable to work, study, or manage day-to-day activities due to distress.	Immediately after intervention (post 4-week intervention) and up to 3 months