Clinical trial NCT05160376: Efficacy of Guided and Unguided Online Self-help Psychological Intervention
Official title: Efficacy of Guided and Unguided Online Self-help Psychological Intervention for Improving Depressive and Anxiety Symptoms: A Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Online Self-help Transdiagnostic Psychological Intervention
Anxiety
Depression
Keywords: Online Self-help
Online Psychological Intervention
Unguided Online Self-help
Guided Online Self-help
Transdiagnostic intervention
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2021-12-16
Enrollment: 90
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: 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.

Detailed description: This study will be a pilot randomized control trial that examines the efficacy of guided and unguided transdiagnostic online self-help cognitive behavioral therapy for reducing symptoms of anxiety and depression in the Hong Kong adult resident population. Despite online self-help intervention has been widely recognized by its efficacy in improving depression and anxiety symptoms, the existing literature overlooks the mechanism of change and the potential predictors of online treatment outcome, as well as the effect of therapist's guidance on participants' treatment expectancy and its mediating effect on treatment outcome. However, the aforementioned research gaps are essential for optimizing the efficacy of online self-help interventions.

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.

Eligibility criteria: Inclusion Criteria:

1. 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);
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:

1. Had received psychotherapy for depression and/or anxiety in the past 6 months;
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.

Primary outcomes:
measure: Change in Depressive Symptoms - The Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
measure: Change in Anxiety Symptoms - The General Anxiety Disorder-7 (GAD-7)
timeFrame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Secondary outcomes:
measure: Change in Quality-adjusted Life Years - The Short Form Six-Dimension (SF-6D)
timeFrame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
measure: Change in Insomnia Severity Index (ISI)
timeFrame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
measure: Change in the Perceived Stress Scale (PSS)
timeFrame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
measure: Change in emotional regulation strategies - Emotion Regulation Questionnaire (ERQ)
timeFrame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
measure: Change in frequency of applying CBT-based skills - Frequency of Actions and Thoughts Scale (FATS)
timeFrame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
measure: Change in Positive Beliefs about Rumination Scale - Adapted Version (PBRS-A)
timeFrame: Baseline Assessment Phrase, Post-treatment Assessment Phrase (Immediately after Treatment), Post-treatment Assessment Phrase (Four-week after Treatment)
Other outcomes:
Locations:
city: Sha Tin
country: Hong Kong
facility: The Chinese University of Hong Kong
Study officials:
References: