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

NCT04985422 | Unknown

• 1 other identifier: Flow EMI - Depressive Symptom
• Study Type: interventional
• Target: 262
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depressive Symptoms

Keywords

Depressive symptoms; Ecological momentary intervention; Rumination; Distress; Stressors; Mental health

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in rumination level, as assessed using the 10-item ruminative response scale (RRS-10)

  Immediately after intervention (post 4-week intervention) and up to 3 months

• Change in psychological distress, as assessed using the Kessler Psychological Distress Scale (K6)

  Immediately after intervention (post 4-week intervention) and up to 3 months

• Change in level of functioning, as reflected by presenteeism and absenteeism due to distress

  Immediately after intervention (post 4-week intervention) and up to 3 months

Study Arms (2)

Experimental group: Smartphone-based daily ecological momentary intervention (EMI)

EXPERIMENTAL

The experimental group receives 4 weeks of smartphone-based daily EMI. Participants are prompted 6 times a day (with an interval of at least 30 minutes between each digital prompt), on a daily basis over the 4-week period. Within 15 minutes of the digital prompt, participants are to first complete a brief (1-2 minutes) momentary survey ("ecological momentary assessment" \[EMA\]), and subsequently select 1 out of 5 personalised intervention actions of interest to complete in the moment (time to complete spans from 1 minute to 5 minutes). The interventions are brief simple behavioural actions (mostly 1-2 minutes, up to 5 minutes) which could be done in the moment. Simple action tasks include guided breathing, mindful walking, and mindful sound hearing (etc.). Participants could also use the platform at any other times to redo intervention actions when preferred. Individualised reports for the EMI completed are provided.

Behavioral: Smartphone-based Daily Ecological Momentary Intervention

Control group: Smartphone-based weekly-delivered information

OTHER

The control group receives 4 weeks of smartphone-based weekly-delivered information. The smartphone system (SMS + Qualtrics) as well as the contents of the interventions are identical to those provided to the EMI group. Rather than interventions delivered in the moment on a daily basis over the 4-week period, participants in the control group are provided with a new set of information on a weekly basis over the 4-week period (4 sets in total, 1 new set each week). Participants in the control group are also required to complete a brief 5-minute assessment within 3 days. The information includes brief simple behavioural actions (mostly 1-2 minutes, up to 5 minutes) which could be done anytime. Simple action tasks include guided breathing, mindful walking, and mindful sound hearing (etc.). Participants could complete any intervention of interest in the information provided at any time throughout the 4-week period.

Behavioral: Smartphone-based Weekly-delivered Information

Interventions

Smartphone-based Daily Ecological Momentary Intervention BEHAVIORAL

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.

Experimental group: Smartphone-based daily ecological momentary intervention (EMI)

Smartphone-based Weekly-delivered Information BEHAVIORAL

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.

Control group: Smartphone-based weekly-delivered information

Eligibility Criteria

• Age: 15 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (12)

• 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.

  PMID: 24676485 BACKGROUND

• 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.

  PMID: 22190846 BACKGROUND

• 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.

  PMID: 26158958 BACKGROUND

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

  PMID: 18298268 BACKGROUND

• 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.

  PMID: 31928765 BACKGROUND

• 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.

  PMID: 32155789 BACKGROUND

• 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.

  PMID: 32289019 BACKGROUND

• 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.

  PMID: 33618286 BACKGROUND

• 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.

  PMID: 33545423 BACKGROUND

• 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.

  PMID: 33317325 BACKGROUND

• 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.

  PMID: 29856567 BACKGROUND

• 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.

  PMID: 24497255 BACKGROUND

MeSH Terms

Conditions

Depression; Rumination Syndrome; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Gastrointestinal Diseases; Digestive System Diseases; Feeding and Eating Disorders; Mental Disorders; Personal Satisfaction

Study Officials

• Eric YH Chen, MA

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

• Stephanie MY Wong, BSocSc

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eric YH Chen, MA

CONTACT

(+852) 22554486; eyhchen.hk@gmail.com

Stephanie MY Wong, BSocSc

CONTACT

(+852) 90371111; steph.my.wong@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chi-Li Pao Foundation Professor in Psychiatry, Chair Professor

Study Record Dates

• First Submitted: July 20, 2021
• First Posted: August 2, 2021
• Study Start: July 26, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 11, 2023

Record last verified: 2023-05

Locations

HK (1)