Incorporating Ecological Momentary Assessment and Personalized Telephone Support Into Group-Based Exercise Intervention for Depressive Symptoms

The Chinese University of Hong Kong

Status: Enrolling

Conditions: Depression

Treatments: Behavioral: Group-based exercise intervention (EXE); Behavioral: Group-based exercise intervention with EMA and personalized telephone support (SUP)

Study type: Interventional

Funder types: Other

Identifiers

NCT05704504

PSY028

Details and patient eligibility

About

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).

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

60 participants in 3 patient groups

Group-based exercise intervention with EMA and personalized telephone support (SUP)

Experimental group

Description:

Participants in the SUP group will receive a 6-week group-based exercise intervention with ecological momentary assessment (EMA)and personalized telephone support.

Treatment:

Behavioral: Group-based exercise intervention with EMA and personalized telephone support (SUP)

Group-based exercise intervention (EXE)

Active Comparator group

Description:

Participants in the EXE group will receive a 6-week group-based exercise intervention.

Treatment:

Behavioral: Group-based exercise intervention (EXE)

No intervention control group (CON)

No Intervention group

Description:

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.