The Effect of Group-based Lifestyle Medicine Intervention and CBT on Depressive Symptoms

The Chinese University of Hong Kong

Status: Not yet enrolling

Conditions: Depression

Treatments: Behavioral: Lifestyle medicine intervention; Behavioral: Cognitive-behavioral therapy for depression (CBT-D)

Study type: Interventional

Funder types: Other

Identifiers

NCT05716464

PSY029

Details and patient eligibility

About

The objective of this randomized controlled trial is to evaluate and compare the efficacy of group-based lifestyle medicine intervention and cognitive-behavioral therapy for depression (CBT-D) for Chinese adults with depressive symptoms.

Prior to all study procedures, eligible participants will be required to complete an online informed consent (with telephone support). Around 40 eligible participants aged between 18 to 65 with depression (Patient Health Questionnaire-9 [PHQ-9] ≥ 10) will be randomly assigned to the Lifestyle Medicine group (LM group), or the CBT-D group in a ratio of 1:1. Participants in both groups will receive interventions either through lifestyle medicine intervention or CBT-D group therapy for 6 consecutive weeks. The outcomes of interest will include depressive, anxiety, and insomnia symptoms, quality of life, functional impairment, and health-promoting behaviours at baseline (week 0), immediate (week 7) and 3-month post-intervention assessments (week 19). Treatment credibility and acceptability will be collected before and immediately after treatment.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Chinese adults reside in Hong Kong;
2. Aged between 18 to 65 years;
3. Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10, indicating at least moderate level of depressive symptoms;
4. Able to read and understand Chinese/Cantonese and are fluent in Cantonese;
5. 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 intervention study that may potentially improve mental health;
5. 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);
6. Pregnancy;
7. Hospitalization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Lifestyle medicine intervention (LM)

Experimental group

Description:

Participants in the LM group will receive a 6-week group-based lifestyle medicine intervention.

Treatment:

Behavioral: Lifestyle medicine intervention

Cognitive-behavioral therapy for depression (CBT-D)

Experimental group

Description:

Participants in the CBT-D group will receive a 6-week group-based cognitive-behavioral therapy for depression.

Treatment:

Behavioral: Cognitive-behavioral therapy for depression (CBT-D)