Back to resultsThe Effect of Group-based Lifestyle Medicine Intervention and CBT on Depressive Symptoms
Primary Purpose
Depression
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Lifestyle medicine intervention
Cognitive-behavioral therapy for depression (CBT-D)
Sponsored by
About this trial
This is an interventional treatment trial for Depression focused on measuring Depression, Lifestyle medicine, Cognitive-behavioral therapy for depression, Randomised controlled trial
Eligibility Criteria
Inclusion Criteria: Chinese adults reside in Hong Kong; Aged between 18 to 65 years; Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10, indicating at least moderate level of depressive symptoms; Able to read and understand Chinese/Cantonese and are fluent in Cantonese; Willing to provide informed consent and comply with the trial protocol. Exclusion Criteria: Received psychotherapy for depression in the past 6 months; A change in psychotropic drugs that target depression within 2 weeks before the baseline assessment; 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); Currently participating in another intervention study that may potentially improve mental health; 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); Pregnancy; Hospitalization.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Lifestyle medicine intervention (LM)
Cognitive-behavioral therapy for depression (CBT-D)
Arm Description
Participants in the LM group will receive a 6-week group-based lifestyle medicine intervention.
Participants in the CBT-D group will receive a 6-week group-based cognitive-behavioral therapy for depression.
Outcomes
Primary Outcome Measures
Change in the Patient Health Questionnaire (PHQ-9)
The PHQ-9, a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Secondary Outcome Measures
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
Change in the Insomnia Severity Index (ISI)
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Change in the Health-Promoting Lifestyle Profile (HPLP-II)
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Change in the Sheehan Disability Scale (SDS)
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Change in the Credibility-Expectancy Questionnaire (CEQ)
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. Specific wording referencing "anxiety" was changed to refer to "depression".
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from a short form of the International Physical Activity Questionnaire - Chinese version a short form of the IPAQ-C. The questions include: "On a typical weekday in the last 7 days, how many hours per day did you typically spend sitting?"; "On a typical weekend in the last 7 days, how many hours per day did you typically spend sitting?"; "During the last 7 days, on how many days did you do at least 10 minutes moderate physical activity/vigorous physical activity/walking?"; "How much time did you usually spend doing the moderate physical activity /vigorous physical activity/walking on one of those days?"; and "How much time did you usually spend engaging in physical activity while seated and standing on one of those days?"
Change in the Treatment Acceptability and Adherence Scale (TAAS)
TAAS is a self-reported, ten-item questionnaire that is rated by a seven-point Likert scale from 1 to 7, and it aims at evaluating the clients' attitude toward the treatment sessions by four domains, including acceptability, adherence, drop-out, and distress. Specific wording referencing "anxiety" was changed to refer to "depression".
Full Information
NCT ID
NCT05716464
First Posted
January 28, 2023
Last Updated
January 28, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT05716464
Brief Title
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
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Lifestyle medicine, Cognitive-behavioral therapy for depression, Randomised controlled trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lifestyle medicine intervention (LM)
Arm Type
Experimental
Arm Description
Participants in the LM group will receive a 6-week group-based lifestyle medicine intervention.
Arm Title
Cognitive-behavioral therapy for depression (CBT-D)
Arm Type
Experimental
Arm Description
Participants in the CBT-D group will receive a 6-week group-based cognitive-behavioral therapy for depression.
Intervention Type
Behavioral
Intervention Name(s)
Lifestyle medicine intervention
Intervention Description
The lifestyle medicine intervention includes six weekly sessions (i.e., participants will receive the intervention once per week) that are related to the following topics: (a) lifestyle psychoeducation, (b) physical activity, (c) dietary recommendation, (d) stress management, (e) sleep management and (f) motivation and goal-setting techniques. Each topic will be delivered during each face-to-face session and the duration of each session will be around 120 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-behavioral therapy for depression (CBT-D)
Intervention Description
The group-based CBT-D therapy includes six weekly sessions (i.e., participants will attend one 120-minute, face-to-face group therapy per week, and will be asked to practice taught-skills every day, for 42 days) that are related to the following topics: (a) psychoeducation, (b) cognitive restructuring, (c) behavioral activation, (d) self-care and relapse prevention.
Primary Outcome Measure Information:
Title
Change in the Patient Health Questionnaire (PHQ-9)
Description
The PHQ-9, a 9-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of depression, which scores each of the nine DSM-IV criteria as "0" (not at all) to "3" (nearly every day).
Time Frame
Baseline, immediate post-treatment, and 12-week follow-up
Secondary Outcome Measure Information:
Title
Change in the Generalized Anxiety Disorder 7-Item Scale (GAD-7)
Description
The GAD-7, a 7-item questionnaire used for screening, diagnosing, monitoring, and measuring the severity of anxiety over the past two weeks on a 4-point scale, "0" (not at all) to "4" (nearly every day).
Time Frame
Baseline, immediate post-treatment, and 12-week follow-up
Title
Change in the Insomnia Severity Index (ISI)
Description
ISI is a 7-item scale designed to evaluate perceived insomnia severity. Ratings on the 5-point Likert scale are obtained on the perceived severity of sleep-onset, sleep-maintenance, early morning awakening problems, satisfaction with current sleep pattern, interference with daily functioning, noticeably of impairment attributed to the sleep problem, and level of distress caused by the sleep problem.
Time Frame
Baseline, immediate post-treatment, and 12-week follow-up
Title
Change in the Short Form (Six-Dimension) Health Survey (SF-6D)
Description
SF-6D is a preference-based single index measure of health. A six-digit number represents each SF-6D health state, each digit denotes the level of one of six SF-6D dimensions: physical functioning, role limitation, social functioning, bodily pain, mental health, and vitality.
Time Frame
Baseline, immediate post-treatment, and 12-week follow-up
Title
Change in the Health-Promoting Lifestyle Profile (HPLP-II)
Description
The 52-item HPLPII is composed of a total scale and six subscales to measure behaviors in the theorized dimensions of health-promoting lifestyle: spiritual growth, interpersonal relations, nutrition, physical activity, health responsibility, and stress management.
Time Frame
Baseline, immediate post-treatment, and 12-week follow-up
Title
Change in the Sheehan Disability Scale (SDS)
Description
SDS is a brief, 5-item self-report tool that assesses functional impairment in work/school, social life, and family life.
Time Frame
Baseline, immediate post-treatment, and 12-week follow-up
Title
Change in the Credibility-Expectancy Questionnaire (CEQ)
Description
The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success. Specific wording referencing "anxiety" was changed to refer to "depression".
Time Frame
Baseline and immediate post-treatment
Title
Change in the International Physical Activities Questionnaire - Chinese version (IPAQ-C)
Description
Participants' sitting time, walking time and moderate and vigorous physical activity are assessed by 5 questions from a short form of the International Physical Activity Questionnaire - Chinese version a short form of the IPAQ-C. The questions include: "On a typical weekday in the last 7 days, how many hours per day did you typically spend sitting?"; "On a typical weekend in the last 7 days, how many hours per day did you typically spend sitting?"; "During the last 7 days, on how many days did you do at least 10 minutes moderate physical activity/vigorous physical activity/walking?"; "How much time did you usually spend doing the moderate physical activity /vigorous physical activity/walking on one of those days?"; and "How much time did you usually spend engaging in physical activity while seated and standing on one of those days?"
Time Frame
Baseline, immediate post-treatment, and 12-week follow-up
Title
Change in the Treatment Acceptability and Adherence Scale (TAAS)
Description
TAAS is a self-reported, ten-item questionnaire that is rated by a seven-point Likert scale from 1 to 7, and it aims at evaluating the clients' attitude toward the treatment sessions by four domains, including acceptability, adherence, drop-out, and distress. Specific wording referencing "anxiety" was changed to refer to "depression".
Time Frame
Baseline and immediate post-treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Chinese adults reside in Hong Kong;
Aged between 18 to 65 years;
Have a Patient Health Questionnaire-9 (PHQ-9) score ≥ 10, indicating at least moderate level of depressive symptoms;
Able to read and understand Chinese/Cantonese and are fluent in Cantonese;
Willing to provide informed consent and comply with the trial protocol.
Exclusion Criteria:
Received psychotherapy for depression in the past 6 months;
A change in psychotropic drugs that target depression within 2 weeks before the baseline assessment;
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);
Currently participating in another intervention study that may potentially improve mental health;
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);
Pregnancy;
Hospitalization.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Lai
Phone
3943 6575
Email
vivian.lai@link.cuhk.edu.hk
First Name & Middle Initial & Last Name or Official Title & Degree
Vincent Wong
Phone
3943 6575
Email
vincentwongWH@link.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fiona Yan-Yee Ho, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of Group-based Lifestyle Medicine Intervention and CBT on Depressive Symptoms
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