Clinical trial NCT05716464: The Effect of Group-based Lifestyle Medicine Intervention and CBT on Depressive Symptoms
Official title: The Effect of Group-based Lifestyle Medicine Intervention and Cognitive Behavioural Therapy on Depressive Symptoms: A Pilot Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Keywords: Depression
Lifestyle medicine
Cognitive-behavioral therapy for depression
Randomised controlled trial
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2023-02-08
Enrollment: 40
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 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change in the Patient Health Questionnaire (PHQ-9)
timeFrame: Baseline, immediate post-treatment, and 12-week follow-up
Secondary outcomes:
measure: Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
timeFrame: Baseline, immediate post-treatment, and 12-week follow-up
measure: Change in the Insomnia Severity Index (ISI)
timeFrame: Baseline, immediate post-treatment, and 12-week follow-up
measure: Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
timeFrame: Baseline, immediate post-treatment, and 12-week follow-up
measure: Change in the Health-Promoting Lifestyle Profile (HPLP-II)
timeFrame: Baseline, immediate post-treatment, and 12-week follow-up
measure: Change in the Sheehan Disability Scale (SDS)
timeFrame: Baseline, immediate post-treatment, and 12-week follow-up
measure: Change in the Credibility-Expectancy Questionnaire (CEQ)
timeFrame: Baseline and immediate post-treatment
measure: Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
timeFrame: Baseline, immediate post-treatment, and 12-week follow-up
measure: Change in the Treatment Acceptability and Adherence Scale (TAAS)
timeFrame: Baseline and immediate post-treatment
Other outcomes:
Locations:
Study officials:
affiliation: Chinese University of Hong Kong
name: Fiona Yan-Yee Ho, PhD
role: STUDY_CHAIR
References: