Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools

Depression Clinical Trial

Official title:

Enhancing Group Lifestyle Intervention for Depression With Self-Tracking Tools: A Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04875663
• Other study ID #: PSY015
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: June 30, 2022

Study information

• Verified date: May 2021
• Source: Chinese University of Hong Kong
• Contact: Vincent Wing-Hei Wong
• Phone: +852 39436575
• Email: vincentwongWH[@]link.cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will be a randomized controlled trial on the effects of group-based LM as an intervention for depression. Prior to all study procedures, an online informed consent (with phone support) will be obtained from potential participants. Around 90 eligible participants will be randomly assigned to either the LM intervention with self-tracking tools (LM/S), pure LM intervention (LM), or care-as-usual (CAU) control group in a ratio of 1:1:1. The randomization will be performed by an independent assessor using a computer-generated list of numbers. In order to obtain unbiased data with respect to the participants' attitudes and behaviors, incomplete disclosure will be used to withhold the self-tracking component in this trial. Participants in the two LM groups will receive six weekly group lifestyle modification sessions (~2 hours each) at the Chinese University of Hong Kong (an online approach will be adopted if face-to-face sessions are not possible due to COVID-19). The group treatment will primarily be delivered by clinical psychology trainees under the supervision of a clinical psychologist and other healthcare professionals such as a dietitian and a fitness trainer. The CAU group will continue receiving the routine care as usual and be given a smartphone-based LM intervention after the completion of follow-up assessments. Both the treatment groups and control group will complete a set of online questionnaires before the treatment commences, immediately after treatment, and 12 weeks after the treatment sessions are completed. In addition, participants in the LM/S group will complete a set of self-developed survey questions related to lifestyle and mood on a daily basis.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Hong Kong residents aged = 18 years

2. Cantonese language fluency and readability

3. A Patient Health Questionnaire 9 items (PHQ-9) score of at least 10, indicating a moderate level of depression

4. Possession of an internet-enabled mobile device (iOS or Android operating system)

5. Willingness to provide informed consent and comply with the trial protocol

Exclusion Criteria:

1. Current serious suicidal risk (non-fleeting intent or plan) as assessed by a PHQ-9 Item 9 score > 2 (referral information to professional mental health services will be provided)

2. Any 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 or a change in diet are not recommended by physicians)

3. Current involvement in lifestyle changes supervised by professionals

4. Unstable medication or current participation in any psychotherapy for depression

5. Pregnancy

6. Hospitalization

7. Current participation in any other trial(s)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• Lifestyle Medicine
Lifestyle intervention including diet, sleep, exercise, relaxation and mindfulness

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Sha Tin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the Credibility-Expectancy Questionnaire (CEQ)	The 6-item CEQ yielded ratings of treatment credibility, acceptability/satisfaction, and expectations for success.	Baseline and immediately after treatment
Primary	Change in the Patient Health Questionnaire (PHQ-9)	The PHQ-9, a 20-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).	Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Secondary	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).	Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Secondary	Change in 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.	Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Secondary	Change in the World Health Organization Quality of Life Instruments (WHOQOL-BREF)	WHOQOL-BREF consists of 24 items assessing perception of quality of life (QoL) in four domains, including physical health, psychological, social relationships, and environment, and two items on overall QoL and general health. The domain scores were transformed into a linear scale between 0 and 100 following the scoring guidelines. A higher score indicated a better QoL.	Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Secondary	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.	Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Secondary	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	Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed
Secondary	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.	Baseline, immediately after treatment, and 12 weeks after the treatment sessions are completed