NCT05160376

Brief Summary

This study will examine the efficacy of guided and unguided online transdiagnostic self-help cognitive behavioral therapy (CBT) for reducing anxiety and/or depression symptoms in Hong-kong residents. Numerous literature demonstrates online self-help interventions' efficacy on depression and anxiety. Nonetheless, existing research overlooks the mechanism of change, the online treatment outcome's potential predictors, and the effect of therapist's guidance on participants' treatment expectancy and its mediating effect on treatment outcome, which are essential to optimize intervention's efficacy. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 3, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 16, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 24, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

April 5, 2022

Status Verified

March 1, 2022

Enrollment Period

2 months

First QC Date

December 3, 2021

Last Update Submit

March 25, 2022

Conditions

Online Self-help Transdiagnostic Psychological InterventionAnxietyDepression

Keywords

Online Self-helpOnline Psychological InterventionUnguided Online Self-helpGuided Online Self-helpTransdiagnostic intervention

Outcome Measures

Primary Outcomes (2)

  • Change in Depressive Symptoms - The Patient Health Questionnaire-9 (PHQ-9)

    The Patient Health Questionnaire-9 (PHQ-9) is a self-report measure that consists of 4-point Likert-scale questions that assess the severity of depressive symptoms. This measure reflects the DSM-IV diagnostic criteria of depression. Higher score means that the respondent has more depressive symptoms. Total score categories: 0-4 is no clinically significant depressive symptoms, 5-9 indicates mild depressive symptom,10-14 indicates moderate depressive symptoms, 15-19 indicates moderately severe depressive symptoms, 20-27 indicates extremely severe depressive symptom. This measure also shows good convergent validity with other measures and are widely used in mental health research (Beard et al., 2016; Kroenke et al., 2010)

    Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)

  • Change in Anxiety Symptoms - The General Anxiety Disorder-7 (GAD-7)

    The General Anxiety Disorder-7 (GAD-7) is a self-report measure to evaluate the severity of anxiety symptoms. This measure reflects the DSM-IV diagnostic criteria of anxiety. Total score categories: 0-4 is no clinically significant depressive symptoms, 5-9 indicates mild depressive symptom,10-14 indicates moderate depressive symptoms, 15-19 indicates moderately severe depressive symptoms, 20-27 indicates extremely severe depressive symptom. This measure also shows good convergent validity with other measures and are widely used in mental health research (Beard et al., 2016; Kroenke et al., 2010)

    Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)

Secondary Outcomes (6)

  • Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)

    Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)

  • Change in Insomnia Severity Index (ISI)

    Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)

  • Change in the Perceived Stress Scale (PSS)

    Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)

  • Change in emotional regulation strategies - Emotion Regulation Questionnaire (ERQ)

    Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)

  • Change in frequency of applying CBT-based skills - Frequency of Actions and Thoughts Scale (FATS)

    Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)

  • +1 more secondary outcomes

Study Arms (3)

Guided Intervention Group

EXPERIMENTAL

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.

Other: Self-help CBT with email reminder and text messageOther: Feedback calls on participants' progress

Unguided Intervention Group

EXPERIMENTAL

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.

Other: Self-help CBT with email reminder and text message

Wait-list Control Group

NO INTERVENTION

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.

Interventions

Self-help CBT with email reminder and text messageOTHER

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

Guided Intervention GroupUnguided Intervention Group
Feedback calls on participants' progressOTHER

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

Guided Intervention Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have anxiety and/or depression symptoms, scoring 10 or above, in accordance with Patient Health Questionnaire (PHQ-9) or General Anxiety Disorder-7 (GAD-7);
  • Hong Kong residents aged 18-65;
  • Have access to the internet and have a valid email address for communication;
  • Able to read Chinese and type in Chinese or English; and
  • Willing to provide informed consent.

You may not qualify if:

  • Had received psychotherapy for depression and/or anxiety in the past 6 months;
  • 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;
  • Will participate in another similar study/ other similar studies concurrently;
  • Any suicidal ideation (scoring above 2 in item 9 in PHQ-9)
  • Have reported substance abuse or dependence history;
  • Had changes in psychotropic drugs within 2 weeks before baseline assessment; and
  • Pregnancy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Anxiety DisordersDepression

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 3, 2021

First Posted

December 16, 2021

Study Start

January 24, 2022

Primary Completion

March 26, 2022

Study Completion

July 31, 2022

Last Updated

April 5, 2022

Record last verified: 2022-03

Locations

HK(1)