Clinical trial NCT05704504: Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms
Official title: Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Exercise
Ecological momentary assessment
Randomised controlled trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this proposed pilot randomized controlled trial is to examine the efficacy and acceptability of using smartphone-delivered ecological momentary assessment (EMA) and personalized telephone support to promote adherence to a 6-week group-based exercise intervention for improving depressive symptoms.

Prior to all study procedures, eligible participants are required to complete an online informed consent via an in-house smartphone application, Longitudinax Pro. Around 60 eligible participants aged 18-65 years old with Patient Health Questionnaire (PHQ-9) total score ≥10 (Kroenke et al., 2001) and International Physical Activity Questionnaire (IPAQ) total score \<600 MET/week (Lai et al., 2018; Macfarlane et al., 2007) will be randomly assigned to either 1) group-based exercise intervention with EMA and personalized telephone support (SUP), 2) group-based exercise intervention (EXE), or no intervention control group (CON) in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. The SUP and EXE groups will participate in a 6-week group-based exercise intervention. The intervention includes three biweekly group-based exercise sessions lasting for 120 minutes each (i.e., Week 1, 3, and 5). In addition, participants in the SUP will receive daily smartphone-delivered EMAs throughout the intervention period (i.e., 6-week) and 15-minute personalized telephone support delivered by a research personnel in Week 2, 4, and 6, respectively. Participants in the CON group will not be given any intervention during the study period but will be advised to remain their typical lifestyle throughout the trial period. The primary outcome of interest include depressive symptoms as measured by PHQ-9. The secondary outcomes will include anxiety symptoms, perceived insomnia severity, quality of life, functional impairment, and intervention evaluation at immediate post-intervention (Week 7) and 3-month follow-up assessments (Week 19).


Eligibility criteria: Inclusion Criteria:

1. Hong Kong residents
2. Aged ≥ 18 years
3. Able to read Chinese and type in Chinese or English
4. Have a Patient Health Questionnaire-9(PHQ-9) item score ≥10 indicating at least moderate level of depressive symptoms
5. Have an International Physical Activities Questionnaire- Chinese version (IPAQ-C) score \<600 MET indicating physically inactive.
6. Have an Internet-enabled mobile device (iOS or Android operating system)
7. Willing to provide informed consent and comply with the trial protocol

Exclusion Criteria:

1. Received psychotherapy for depression in the past 6 months
2. A change in psychotropic drugs that target depression within 2 weeks before the baseline assessment
3. A PHQ-9 question 9 score higher than 2, indicating a moderate level of suicidal risk that requires active crisis management (referral information to professional mental health services will be provided)
4. Currently participating in another interventional study that may potentially improve mental health
5. Pregnancy
6. Self-disclosure of any psychiatric,medical or neurocognitive disorder(s) that makes participation unsuitable based on the team's clinical experience or interferes with adherence to the lifestyle modification (e.g., where exercise is not recommended by physicians)

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, immediate post-intervention, and 3-month follow-up
Secondary outcomes:
measure: Change in the Generalized Anxiety Disorder 7-item Scale (GAD-7)
timeFrame: Baseline, immediate post-intervention, and 3-month follow-up
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: Baseline, immediate post-intervention, and 3-month follow-up
measure: Change in the Short Form (Six-Dimension) Health Survey - The Chinese (Hong Kong) Version
timeFrame: Baseline, immediate post-intervention, and 3-month follow-up
measure: Change in the Short Multidimensional Inventory Lifestyle Evaluation (SMILE)
timeFrame: Baseline, immediate post-intervention, and 3-month follow-up
measure: Change in the Sheehan Disability Scale (SDS)
timeFrame: Baseline, immediate post-intervention, and 3-month follow-up
measure: Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
timeFrame: Baseline, immediate post-intervention, and 3-month follow-up
measure: Change in the Treatment Acceptability and Adherence Scale (TAAS)
timeFrame: Baseline and immediate post-intervention
measure: Change in Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediate post-intervention
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: