Enhancing group way of life intervention for melancholy with ecological momentary evaluation: a pilot randomized managed trial

This pilot three-arm, parallel-group RCT was performed on the Department of Psychology, The Chinese University of Hong Kong, Hong Kong. Ethical approval was sought from the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research Ethics Committee (The Joint CUHK-NTEC CREC) (Reference No. 2021.369), and the trial protocol was pre-registered on ClinicalTrials.gov (Reference No. NCT04875663; Registration Date: 06/05/2021). This research adopted the Consolidated Standards for Reporting Trials (CONSORT) assertion: extension to randomized pilot and feasibility trials for reporting²⁷.

Study inhabitants and process

A complete of 56 members had been recruited by printed posters on the CUHK, the CUHK mass mail system, phrase of mouth, and commercials on social media platforms, together with Facebook and Instagram. Eligible members had been Hong Kong residents who met the next standards: (1) aged 18 years or older; (2) had at the very least average depressive symptomatology, as indicated by a Patient Health Questionnaire-9 (PHQ-9) whole rating ≥ 10²⁸; (3) possessed an internet-enabled cell machine, appropriate with both iOS or Android working methods; (4) demonstrated fluency in Cantonese; (5) had been capable of comprehend Chinese; and (6) agreed to offer knowledgeable consent and cling to the trial protocol. Participants had been excluded in the event that they: (1) offered a present critical suicidal threat (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 rating > 2 (info for skilled psychological well being service referrals was offered); (2) had any medical or neurocognitive dysfunction(s) that, based mostly on the analysis group’s medical expertise, made participation unsuitable or may intrude with adherence to the life-style modifications (e.g., train or dietary adjustments weren’t advisable by physicians); (3) had been presently concerned in professionally supervised way of life adjustments; (4) had unstable remedy previously 3 months or had been receiving psychotherapy for melancholy; (5) had been pregnant; (6) had been hospitalized; and (7) enrolled in every other trial(s).

Prospective members had been requested to finish a set of on-line screening questionnaires on an internet survey platform, which included (1) PHQ-9 assessing the extent of depressive signs and suicidal ideation; (2) a self-report guidelines for eligibility standards; and (3) a non-validated demographic questionnaire. Eligible members had been subsequently invited to hitch the research by a analysis assistant by an roughly 20-minute cellphone name. During the decision, eligible members had been knowledgeable concerning the research goal, procedures, restrictions, knowledge dealing with, privateness measures, potential dangers, and the voluntary nature of participation. Interested members had been guided to obtain an in-house smartphone utility (Longitudinax Pro) to offer digital knowledgeable consent and for final result knowledge assortment. Upon granting consent and finishing the baseline evaluation, members had been randomly assigned to the LM/S (n = 18), PLM (n = 20), or CAU (n = 18) teams with a ratio of 1:1:1 by an unbiased statistician utilizing a computer-generated checklist of numbers. Due to the character of the trial design, it was not possible to blind the intervention allocation from members and therapists. To guarantee unbiased knowledge relating to members’ attitudes and behaviors, incomplete disclosure was employed by withholding details about the EMA part on this research. Specifically, in the course of the knowledgeable consent course of, all members had been instructed that this RCT consisted of solely 2 arms, i.e., a group-based LM intervention arm and a CAU arm. The EMA part was withheld from members within the PLM and CAU teams all through the trial. In distinction, these within the LM/S group believed that every one members receiving the group multicomponent LM intervention had entry to the smartphone-delivered EMA utility. After finishing the 3-month follow-up evaluation (Week 19), a debriefing session was held to disclose the usage of EMA within the research and clarify the rationale behind withholding this info.

After randomization, the analysis assistant contacted members within the LM/S and PLM teams by way of textual content messages to debate group intervention preparations, whereas members within the CAU group had been knowledgeable of the dates for the quick post-intervention (Week 7) and 3-month follow-up assessments (Week 19). Throughout the trial interval, members had been capable of contact the analysis assistant solely for non-therapeutic help. This included addressing technical points associated to the Longitudinax Pro, clarifying evaluation dates, and notifying the analysis assistant about their attendance of intervention periods. To acknowledge members’ time and involvement, those that accomplished all research and evaluation procedures obtained compensation of HK$200 (equal to US$26).

The LM intervention

Participants allotted to the LM/S and PLM teams obtained a 6-week group-based LM intervention. Each 2-hour session (i.e., 12 hours in whole) was performed in a gaggle of 8–10 members to advertise group dialogue and interplay. The manualized intervention was administered by a multidisciplinary group below the common supervision of a doctoral-level medical psychologist (F.Y.H.) and board-certified way of life drugs professionals (V.W.W. and F.Y.H.). The group additionally included a medical psychology trainee, a registered dietitian, and a bodily coach. To make sure the intervention content material was adequately delivered, F.Y.H. noticed every session with subsequent suggestions offered to the therapists.

The group-based LM intervention was knowledgeable by the 5 levels of change outlined within the Transtheoretical Model (TTM)²⁹ and designed by the analysis group drawing upon medical tips and up-to-date analysis findings^15,16,17. The intervention protocol included 4 core way of life modules (i.e., “Core Module 1: Diet and Nutrition”, “Core Module 2: Physical Activity”, “Core Module 3: Sleep Management”, and “Core Module 4: Stress Management”) aiming to boost members’ psychological well being and well-being. In addition, 2 cross-cutting modules (i.e., “Cross-Cutting Module 1: Motivational Interviewing” and “Cross-Cutting Module 2: Goal Setting”) had been designed to interact members in ongoing way of life modifications and promote intervention adherence. The intervention content material was verified by certified medical psychologists, psychiatrists, dietitians, and bodily instructors. In “Core Module 1: Diet and Nutrition”, the dietitian offered evidence-based vitamin info for bettering and sustaining psychological well being. This module lined (1) the connection between weight loss program and psychological well being, (2) suggestions for a wholesome and balanced weight loss program, (3) deciphering vitamin details labels, (4) integrating a nutritious diet into each day life, and (5) motion steps for adopting a nutritious diet. In “Core Module 2: Physical Activity”, the bodily teacher launched and demonstrated numerous sorts of light and adaptable workout routines in the course of the session (i.e., low-intensity home-based and out of doors actions) and offered easy strategies to help members in incorporating workout routines into their each day routines. Besides, the bodily teacher offered bodily exercise suggestions and mentioned the bodily and psychological advantages of normal train. Concerning “Core Module 3: Sleep Management”, primary details about sleep, the vicious cycle of insomnia, and the connection between circadian and social rhythms in reference to sleep and psychological well being had been launched. Practical abilities, equivalent to sleep hygiene, common sleep-wake occasions, wind-down routine, and daytime functioning enchancment, had been additionally included. Regarding “Core Module 4: Stress Management”), the medical psychology trainee delivered psychoeducation on stress, fear administration, gratitude cultivation, and rest strategies, together with diaphragmatic respiratory and progressive muscle rest. Furthermore, the two cross-cutting modules had been applied to spice up motivation, facilitate long-term adherence, and foster enjoyment of the talents realized all through this system. The content material encompassed areas equivalent to inspecting present objectives, the motivation matrix, SMART objective setting, and objective analysis and upkeep.

To facilitate efficient way of life modifications and guarantee a easy transition, the intervention content material was delivered in accordance with the change course of outlined within the TTM²⁹. An in depth intervention construction is depicted in Supplementary Table 1. In every session, the therapists reviewed the members’ weekly logs and homework from the earlier session (aside from the primary session), delivered core intervention content material, assigned homework for the following session, summarized and highlighted the important thing factors of the session, requested members to offer suggestions, and mentioned potential obstacles to way of life modifications. An intervention handout, together with session content material and homework, was distributed for assessment in every session.

In addition to the group-based LM intervention, members within the LM/S group had entry to an in-house smartphone-delivered EMA utility (the app) for the 6-week intervention interval (i.e., 42 days). The app utilized interval-contingent assessments, prompting members to finish surveys at 4 fastened time factors every day (i.e., 12 pm, 3 pm, 6 pm, 9 pm), with automated reminders despatched at 5-minute intervals (as much as 4 reminders per time level) to encourage well timed responses. The EMA app captured real-time knowledge throughout 5 health-related domains, together with weight loss program, bodily exercise, sleep administration, stress administration, and temper state. For weight loss program, members reported whether or not they had eaten because the final check-in. If sure, they specified the kind of consumption (i.e., meals, drinks, snacks, or dietary supplements), uploaded a photograph documenting their deliberate and unplanned consumption, and rated the perceived meal high quality on a 11-point Likert scale (0–10). For bodily exercise, members recorded the variety of minutes engaged in gentle, average, and vigorous train at every time level. Sleep assessments included a each day score of total sleep high quality on an 11-point Likert scale (0–10) at 12 pm and repeated scores of present sleepiness in any respect time factors. Stress administration was assessed by monitoring rest practices (together with sort and period) at every time level, with a further each day score of total stress depth at 9 pm on an 11-point Likert scale (0–10). Finally, temper was measured in any respect time factors utilizing the Chinese model of the International Positive and Negative Affect Schedule Short Form (I-PANAS-SF), which incorporates 10 gadgets rated on a 5-point Likert scale starting from 1 (by no means) to five (at all times)³⁰, capturing each constructive and unfavourable affective states. In every weekly session, therapists spent the preliminary 15 min reviewing members’ adherence to way of life suggestions and discussing potential facilitators and obstacles to way of life modifications.

The CAU

The CAU group didn’t obtain the group-based LM intervention. Instead, they accessed care based mostly on their wants and preferences, which included however weren’t restricted to pharmacological interventions, psychological interventions, and complementary and different drugs. In addition, the analysis assistant reminded members within the CAU to stick to the research protocol. Upon finishing follow-up assessments at Week 19, the CAU group was supplied with a smartphone-delivered LM intervention¹⁰.

Data assortment

All members accomplished a set of on-line questionnaires at baseline (Week 0), quick post-intervention (Week 7), and 3-month post-intervention follow-up assessments (Week 19). The major final result was the imply distinction in depressive signs from baseline to Week 7. Specifically, the principle comparisons had been made between the LM/S and PLM, LM/S and CAU, and PLM and CAU teams. The secondary outcomes included nervousness signs, perceived insomnia severity, QoL, HPBs, practical incapacity, degree of bodily exercise, sociodemographic traits, intervention expectancy and credibility, research attrition (i.e., the speed of participant withdrawal all through the whole analysis interval), intervention attendance (i.e., the imply group periods attended and the proportion of members with full intervention attendance), and EMA compliance price.

Screening and final result measures

The Chinese model of the PHQ-9 was used to measure the severity of depressive signs previously 2 weeks^28,31. The PHQ-9 is a 9-item self-report questionnaire rated on a 4-point Likert scale, with 4 doable response classes: by no means (0), a number of days (1), greater than half the times (2), and practically on daily basis (3). The whole rating is the sum of the 9-item scores and will be divided into 5 classes: no signs (0–4), delicate signs (5–9), average signs (10–14), reasonably extreme signs (15–19), and extreme signs (20–27). A complete rating ≥ 10 was thought-about as a possible medical case^32,33. The PHQ-9 demonstrated good psychometric properties within the current research (Cronbach’s alpha = 0.87).

The Chinese model of the Generalized Anxiety Disorder-7 evaluation (GAD-7) was employed to evaluate the severity of generalized nervousness signs previously 2 weeks^34,35. The GAD-7 is a 7-item self-report questionnaire rated on a 4-point Likert scale, with 4 doable response classes: by no means (0), a number of days (1), greater than half the times (2), and practically on daily basis (3). The whole rating is the sum of the 7-item scores and will be divided into 4 classes: minimal signs (0–4), delicate signs (5–9), average signs (10–14), and extreme signs (15–21). The GAD-7 demonstrated good psychometric properties within the current research (Cronbach’s alpha = 0.92).

The Chinese model of the Insomnia Severity Index (ISI) was used to measure the severity of insomnia signs^36,37. The ISI is a 7-item self-report questionnaire rated on a 5-point Likert scale, with 5 doable response classes for every query: none/very happy (0), delicate/happy (1), average/reasonably happy (2), extreme/dissatisfied (3), and really extreme/very dissatisfied (4). The whole rating is the sum of the 7-item scores and will be divided into 4 classes: no clinically vital signs (0–7), subthreshold signs (8–14), average signs (15–21), and extreme signs (22–28). The ISI demonstrated good psychometric properties within the current research (Cronbach’s alpha = 0.88).

The Chinese model of the World Health Organization Quality of Life Instruments (WHOQOL-BREF) was utilized to evaluate the QoL by way of bodily well being, psychological, social relationships, atmosphere, total QoL, and common well being^38,39. The WHOQOL-BREF consists of 26-item rated on a five-point ordinal scale starting from 1 to five. Following the scoring tips, the scores had been remodeled right into a linear scale from 0 to 100. A better rating signifies higher QoL. The WHOQOL-BREF demonstrated good psychometric properties within the current research (Cronbach’s alpha = 0.94).

HPBs had been measured by the Chinese model of the Health-Promoting Lifestyle Profile (HPLP-II)^40,41. HPLP-II is a 52-item self-report questionnaire assessing six domains of lifestyle-related behaviors, which included religious development (9 gadgets), interpersonal relations (9 gadgets), vitamin (9 gadgets), bodily exercise (8 gadgets), well being duty (9 gadgets), and stress administration (8 gadgets). All gadgets are rated on a 4-point Likert scale with 4 doable response classes: by no means (1), generally (2), ceaselessly (3), and usually (4). The whole and area scores are the imply of the respective merchandise scores. The HPLP-II demonstrated good psychometric properties within the current research (Cronbach’s alpha = 0.71–0.96).

The Chinese model of the Sheehan Disability Scale (SDS) was used to measure the extent of practical impairment^42,43. The SDS is a 3-item self-report questionnaire that measures practical impairment in work/college, social life, and household life. Each merchandise is measured on a 10-point Likert scale, of which 0 represents no disruption and 10 represents excessive disruption. The whole rating is the sum of the 3-item scores. The SDS demonstrated good psychometric properties within the current research (Cronbach’s alpha = 0.92).

Physical exercise degree was evaluated by the International Physical Activities Questionnaire – Chinese model (IPAQ-C)^44,45. The IPAQ-C captures info on numerous varieties and depth ranges of bodily actions, together with strolling, moderate-intensity, and vigorous-intensity actions, and time spent sitting previously 7 days by way of 7 gadgets. The whole exercise degree was calculated by contemplating the time spent in every exercise depth and its corresponding metabolic equal (MET) power expenditure, of which strolling equals 3.3 METs, average actions equal 4 METs, and vigorous actions equal 8 METs⁴⁶. The IPAQ-C demonstrated good psychometric properties within the current research (Cronbach’s alpha = 0.85).

The Chinese model of the Credibility-Expectancy Questionnaire (CEQ) was used to guage intervention expectancy and credibility⁴⁷. The CEQ is a 6-item scale, with the sum of the primary 3 gadgets offering a measure of intervention credibility and the sum of the remaining 3 gadgets inspecting intervention expectancy. Higher scores point out larger credibility and success expectancy for the intervention. The CEQ demonstrated good psychometric properties within the current research (Cronbach’s alpha = 0.72–0.88).

A non-validated demographic survey was used to gather sociodemographic info, together with age, intercourse, degree of training, employment standing, month-to-month earnings degree, and marital standing.

Statistical evaluation

The pattern measurement for this research was decided in accordance with suggestions for pilot medical trials, which recommend together with at the very least 12 members per group⁴⁸. The R Statistical Software v4.3.0⁴⁹ was used for all statistical analyses. A p-value of lower than .05 (two-tailed) was used to find out statistical significance. Effect sizes had been calculated utilizing Cohen’s d, which is decided by dividing the estimated imply variations by the pooled customary deviation (SD)⁵⁰. According to Cohen (2013),⁵¹ impact sizes of 0.2, 0.5, and 0.8 had been thought-about small, medium, and enormous, respectively. Baseline traits had been summarized as means and SDs for roughly usually distributed steady variables and as median and interquartile vary (IQR) for skewed variables. Categorical variables had been reported as frequencies and percentages. Baseline variations throughout teams had been examined utilizing one-way ANOVA for usually distributed steady variables and the Kruskal–Wallis check for non-normal variables. For categorical variables, chi-square assessments (x²) was used when fewer than 20% of anticipated cell counts had been < 5 and no cell had an anticipated rely < 1. When these assumptions had been violated, Fisher’s actual check was employed⁵². Normality was evaluated utilizing Q-Q plots and the Shapiro–Wilk check.

Based on the intention-to-treat (ITT) method, the group (LM/S, PLM, and CAU) by time (Week 0, Week 7, and Week 19) interactions for the first (i.e., depressive signs) and secondary outcomes (i.e., nervousness signs, insomnia signs, QoL, HPBs, practical impairment, bodily exercise ranges) had been evaluated utilizing linear mixed-effects fashions. Significant baseline traits had been included as covariates within the fashions to account for potential confounding results and guarantee comparability throughout teams. Missing knowledge had been dealt with by way of most probability estimation below the belief that knowledge had been lacking at random^53,54. To confirm mannequin assumptions, we assessed normality utilizing Q-Q plots and the Shapiro–Wilk check, and homogeneity of variance with Levene’s check. Due to noticed deviations from the normality assumption for residuals, we utilized a sturdy linear mixed-effects mannequin (RLMM) applied utilizing the ‘robustlmm’ bundle in R, which is particularly designed to offer strong parameter estimation within the presence of outliers or deviations from mannequin assumptions. Tukey’s Honestly Significance Difference (HSD) post-hoc pairwise comparisons had been performed utilizing the estimates derived from the RLMM fashions with p-value adjusted for a number of testing. In addition, RLMMs had been used to look at intervention credibility and expectancy from Week 0 to Week 7.

The research attrition charges of the three teams had been summarized as percentages. The Fisher’s actual check was utilized to look at whether or not dropout charges differed considerably between the three teams. The imply intervention adherence charges between the two intervention teams had been in contrast utilizing a Mann-Whitney U check, whereas the proportion of members with full intervention attendance between the two intervention teams was in contrast utilizing Fisher’s actual check. Clinically vital enchancment was outlined at the least 5-point discount of the PHQ-9 whole rating from Week 0 to Week 7⁵⁵. In addition, we examined the proportion of members who achieved a PHQ-9 whole rating of < 10 between the three teams at Week 7. The Fisher’s actual assessments had been used to research the between-group distinction within the proportion of members who attained clinically vital enchancment and a PHQ-9 whole rating of < 10.

Additionally, we assessed the acceptability of utilizing smartphone-delivered EMA as a self-monitoring instrument for way of life behaviors and temper by way of compliance charges and fatigue results (i.e., response charges to EMA throughout the 6 intervention weeks)^26,56. The compliance charges of EMA had been summarised on the pattern and weekly ranges⁵⁶. Participants who achieved the minimal compliance threshold of the EMA measure (i.e., accomplished ≥ 30% of the whole EMA measure) had been labeled as ‘completers’, in any other case they had been thought-about as ‘non-completers’^56,57,58. Mann-Whitney U check and Fisher’s actual check was performed to establish any vital distinction in baseline measures between ‘completers’ and ‘non-completers’. In addition, a Friedman check was carried out to look at the fatigue results based mostly on weekly EMA compliance charges.