Efficacy of Guided and Unguided Online Self-help Psychological Intervention
NCT ID: NCT05160376
Last Updated: 2022-04-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2022-01-24
2022-07-31
Brief Summary
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96 Hong-kong residents, aged 18-65, with mild to moderate anxiety and/or depression will be recruited. Eligible participants will be randomly assigned to either guided group (Group-1) or unguided group (Group-2) or waitlist control group (Group-3) in a 1:1:1 ratio. Group-1 will receive weekly manualized progress feedback from trained researchers under supervision, after each weekly treatment. Group-2 will not receive the aforementioned feedback. Group-1 and Group-2 will receive reminders on the 5th, 6th and 7th day if weekly treatment is not completed. All participants will complete baseline assessments before treatment, six weekly treatments (except Group-3), a post-treatment assessment immediately and four-week after treatment. Randomly selected participants will complete an individual interview after treatment. Feedback will be gathered through a phone call to improve the intervention in the future.
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Detailed Description
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Prior to all study procedures, online informed consent with phone support will be obtained from potential participants. Around 96 eligible participants will be randomly assigned to either guided intervention group or unguided intervention group or waitlist 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. No deception is necessary.
The participants in the guided intervention group will receive feedback calls (approximately 15 minutes) on participants' progress after each online self-help intervention session. The check-in includes treatment concepts clarification, homework checking, and technical issues solving. The check-ins will be delivered by a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor. The participants in the unguided intervention group will not receive the aforementioned check-ins. The participants in both guided and unguided intervention groups will receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Both technical supports are available for both groups. The waitlist unguided control group will not receive any online self-help intervention. All participants will complete a set of baseline assessments before the first session, a post-treatment assessment immediately after treatment, and a post-treatment assessment four-week after the treatment. Apart from the waitlist control group, both guided and unguided intervention groups will receive a total of six weekly online treatments. Randomly selected participants will complete an individual interview after treatment. Feedback will be gathered through a phone call or online feedback form to improve the intervention in the future.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Guided Intervention Group
The participants in the guided intervention group will receive feedback calls (approximately 15 minutes) on participants' progress from a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor, after each online self-help intervention session. The participants in the guided intervention group will also receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Technical supports are available.
Self-help CBT with email reminder and text message
An online transdiagnostic self-help intervention that is delivered through an online mental health platform.
Email reminder and text message will be sent to remind participant to complete the module
Feedback calls on participants' progress
Feedback calls (approximately 15 minutes) on participants' progress from a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor
Unguided Intervention Group
The participants in the unguided intervention group will not receive the aforementioned feedback calls. The participants in the unguided intervention group will only receive an email reminder and text message if the participants have not completed the required session of that week on the 5th, 6th, and 7th of the same week. Technical supports are available.
Self-help CBT with email reminder and text message
An online transdiagnostic self-help intervention that is delivered through an online mental health platform.
Email reminder and text message will be sent to remind participant to complete the module
Wait-list Control Group
The waitlist control group will not receive any online self-help intervention. Unguided intervention will be provided to the waitlist control group after both the Post-treatment Assessment Phrase are finished.
No interventions assigned to this group
Interventions
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Self-help CBT with email reminder and text message
An online transdiagnostic self-help intervention that is delivered through an online mental health platform.
Email reminder and text message will be sent to remind participant to complete the module
Feedback calls on participants' progress
Feedback calls (approximately 15 minutes) on participants' progress from a clinical psychology trainee or an undergraduate trained psychology student under the supervision of a clinical psychology professor
Eligibility Criteria
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Inclusion Criteria
2. Hong Kong residents aged 18-65;
3. Have access to the internet and have a valid email address for communication;
4. Able to read Chinese and type in Chinese or English; and
5. Willing to provide informed consent.
Exclusion Criteria
2. Have reported the diagnosis of major psychiatric, bipolar disorder, medical or neurocognitive disorders, or have experienced dissociative symptoms that make participation infeasible or interfere with the adherence to the digital self-help intervention;
3. Will participate in another similar study/ other similar studies concurrently;
4. Any suicidal ideation (scoring above 2 in item 9 in PHQ-9)
5. Have reported substance abuse or dependence history;
6. Had changes in psychotropic drugs within 2 weeks before baseline assessment; and
7. Pregnancy.
18 Years
65 Years
ALL
No
Sponsors
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Chinese University of Hong Kong
OTHER
Responsible Party
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Fiona YY Ho
Assistant Professor
Locations
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The Chinese University of Hong Kong
Shatin, , Hong Kong
Countries
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Other Identifiers
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PSY018
Identifier Type: -
Identifier Source: org_study_id
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