Enhancing Internet-Delivered Cognitive Behaviour Therapy With Additional Content

ConditionsLoneliness Depression Anxiety

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Regina

About this trial

This study evaluates the effectiveness of additional content on loneliness offered alongside the Wellbeing Course - an internet-delivered cognitive behavioral therapy (ICBT) intervention for symptoms of depression and anxiety- in improving treatment outcomes for individuals with elevated scores on loneliness seeking treatment for depression and anxiety at a routine care online therapy clinic (the Online Therapy Unit). In this partially randomized control trial, the investigators aim to contribute to the literature by examining whether providing additional content on loneliness alongside the Wellbeing Course enhances engagement, satisfaction, and treatment outcomes among clients experiencing frequent loneliness compared to those completing only the Wellbeing Course. Over 8 weeks, participants will review course materials (with the addition of the loneliness content for those assigned to the loneliness content condition) online and complete questionnaires assessing changes in various outcomes over time.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Saskatchewan resident,

Aged 18 years or older,

Self-reported difficulty with depression and/or anxiety,

Access to a computer (or other appropriate device) and the Internet,

Disqualifiers

Current severe medical or psychiatric condition that requires immediate treatment (e.g. current mania or psychosis, actively suicidal or unable to keep themselves safe, medical condition requiring immediate surgery or other invasive treatment);

Unable to read and understand English (All content is provided in English and staff is English speaking)

Trial design

Design model

Parallel

Treatments tested in this trial

Internet-delivered cognitive behavioral therapy
Behavioral
The Wellbeing Course was developed at Macquarie University, Australia. The Wellbeing Course is a transdiagnostic Internet-delivered cognitive behavioural intervention targeting symptoms of depressive and anxiety disorders. It comprises 5 online lessons targeting: 1) symptom identification and the cognitive behavioural model; 2) thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling; 4) graduated exposure; and 5) relapse prevention. Materials are presented in a didactic (i.e., text-based with visual images) and case-enhanced learning format (i.e., educational stories demonstrate the application of skills) and include homework activities. Lessons are released gradually in a standardized order over 8 weeks. Phone calls will only be made if there is a significant clinical issue requiring therapist attention that cannot be addressed over email (e.g., sudden increase in symptoms). Therapists will spend \~15 mins per week/per client.
Additional Loneliness Content
Behavioral
The additional Loneliness Content was developed at the Online Therapy Unit, University of Regina, Canada. Relevant sections of the resource will be included at the end of each lesson within the Wellbeing Course. The Loneliness Content provides psychoeducation and skills for loneliness using a cognitive behavioral framework. Consistent with the Wellbeing Course content, the Loneliness Content will target 1) identification of loneliness; 2) loneliness thought monitoring and challenging; 3) de-arousal strategies and pleasant activity scheduling for loneliness; 4) behaviours (conversation skills); and 5) relapse prevention.

Treatment groups

494 Participants

are divided into 2 treatment groups

Group A: Wellbeing Course (No Loneliness Content)Active comparator 1 intervention

Group B: Wellbeing Course plus Loneliness ContentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

UCLA Loneliness Scale 3-item (UCLA-3)

Measures loneliness. 3 items are measured on a 3-point Likert scale ranging from 1-3. Scores are summed into a total score ranging from 3 to 9, with higher scores indicating higher levels of perceived loneliness.

Time frame

Baseline (Screening), weeks 4, 8 and 20 from enrollment

Patient Health Questionnaire - 9 (PHQ-9)

Tracking the change in depression symptoms. 9 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed with total scores ranging from 0 to 27. Higher scores are associated with higher depression severity.

Time frame

Baseline (Screening), weeks 1-8 and 20 from enrollment

Generalized Anxiety Disorder - 7 (GAD-7)

Tracking the change in anxiety symptoms. 7 items are measured on a 4-point Likert scale ranging from 0-3. Scores are summed into a total score ranging from 0 to 21, with higher scores indicating more severe self-reported levels of anxiety.

Time frame

Baseline (Screening), weeks 1-8 and 20 from enrollment

Secondary outcomes

Things You Do - 15 (TYD-15)

A measure of behaviors associated with mental health. 15 items are measured on a 5-point Likert scale ranging from 0-4. Subscales include Routine, Thoughts, Social, Activity, and Goals. Scores are summed into subscale scores ranging from 0 to 12, and a total score ranging from 0 to 60, with higher scores indicating increased engagement in behaviours associated with mental health.

Time frame

Baseline (Screening), weeks 4, 8, and 20 from enrollment

Lubben Social Network Scale - 6 items (LSNS-6)

A measure assessing perceived social network and support using 6 items, with two subscales (Family and Friendship). Each subscale contains 3-items, measured on a 6-point Likert scale ranging from 0-5. Items on each subscale are summed to produce a subscale score ranging from 0 to 15. A total scale score ranges from 0 to 30. Higher scores indicate greater perceived support in each subscale or global scale.

Time frame

Baseline (Screening), weeks 8 and 20 from enrollment

Brief Social Support Scale (BS-6)

The BS-6 is a measure of perceived social support, with two subscales (emotional-informational and tangible social support). Each subscale contains 3-items. The first three items of the scale assess perceived tangible support and the remaining three items assess perceived emotional-informational social support. Items are measured on a 4-point Likert scale ranging from 1-4, with subscale scores ranging from 3 to 12, and global scores ranging from 6 to 24. Higher scores indicate greater perceived social support.

Time frame

Baseline (Screening) weeks 8 and 20 from enrollment

Mini Social Phobia Inventory (Mini SPIN)

Measures symptoms of social anxiety. 3 items are measured on a 5-point Likert scale ranging from 0 to 4. Scored are summed into a total score ranging from 0-12, with higher scores indicating greater symptoms of social anxiety.

Time frame

Baseline (Screening), weeks 8 and 20 from enrollment

Other outcomes

Mental Health Service Use

An 11-item questionnaire assessing different parameters of mental health service usage, including providers and mental health services participants have accessed within the past three months, medication participants took for mental health concerns, employment status, and workplace accommodation/disabilities accessed. The questionnaire has been developed by the research team and does not have a score at this time. The questionnaire uses a combination of Likert scale, open-ended, and dichotomous yes/no response options to gauge participants' mental health service use.

Time frame

Baseline (Screening), 20 weeks from enrollment

Homework Reflection Questionnaire

A 5-item questionnaire assessing week-to-week experience in the course, with items inquiring about the lesson participants worked on; effort exerted towards skills; helpfulness of lessons; and client successes, challenges and experiences over the previous week. A combination of checklist, Likert scale \[7-point (1-7)\], and open-ended response options are used to gauge participants' participation. The questionnaire is used for clinicians to monitor treatment. No overall score is produced.

Time frame

Weeks 2 to 8