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Evaluation of internet-based cognitive-behavioral therapy blended with sessions for depression in young adults

Internet-based cognitive behavioral therapy blended with sessions versus self-guided internet-based cognitive behavioral therapy for depression in young adults: a randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12316538
Enrollment
300
Registered
2022-07-25
Start date
2022-08-01
Completion date
Unknown
Last updated
2022-08-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Major depressive disorder in young adults Mental and Behavioural Disorders

Interventions

Eligible subjects will be randomly assigned to 10 weeks of blended CBT for a major depressive episode (MDE) or to 10 weeks of self-guided CBT. A random number generator will be used to assign the part

Sponsors

Pennsylvania State University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Have access to a computer and/or mobile phone with an internet connection and data plan allowing 90 min spent on treatment per week 2. Fluent in the English language in terms of speaking, listening, reading, and writing 3. Aged 18-19 years 4. Presence of depressive symptoms as measured by a score =10 on the QIDS -17-SR 5. Fulfill DSM-5 Criteria for a major depressive episode 6. Depression is deemed the primary concern 7. Those currently taking antidepressants, central stimulants, and/or neuroleptics, will be accepted, if no change in dosage at least 6 weeks prior to study participation

Exclusion criteria

Exclusion criteria: 1. Unable to consent, or actively confirm study participation 2. Ongoing/prior (CBT) treatment within the last 6 months 3. Significant suicidal ideation and/or history of previous suicide attempt 4. Judged to have problem/disorder that warrants more intensive in- person mental health and/or medical treatment (i.e., alcohol, substance use, and/or eating disorder, meets diagnostic criteria for psychotic disorders) 5. Judged to have other current severe problems require other actions at first hand 6. Lack of access to computer and/or mobile phone with an internet connection and sufficient data plan 7. Has ever been diagnosed with autism spectrum disorder and/or Attention Deficit Hyperactivity

Design outcomes

Primary

MeasureTime frame
Depressive symptoms measured using the Quick Inventory of Depressive Symptomatology in adolescents (QIDS-A17-SR) at baseline and 10 weeks (post-treatment)

Secondary

MeasureTime frame
1. Depressive symptoms measured using the QIDS-A17-SR at 6 and 12 months 2. Depressive symptoms measured using the Patient Health Questionnaire 9 (PHQ-9) at baseline, weekly during treatment, and post-treatment (10 weeks) 3. Depressive symptoms measured using the PHQ-9 at 6 and 12 months 4. Remission from DSM-5 depression diagnosis measured using clinical interview at post-treatment (10 weeks) 5. Anxiety symptoms measured using the Generalized Anxiety Disorder Q-IV (GAD-Q-IV) at baseline, during treatment, and post-treatment (10 weeks) 6. Anxiety symptoms measured using the GAD-Q-IV at 6 and 12 months 7. Clinical improvement measured by the Clinical global Impression Scale – Improvement (CGI-I) at post-treatment (10 weeks) 8. Loneliness measured using the UCLA Loneliness Scale-8 (ULS-8) at baseline, post-treatment, 6 months, and 12 months 9. Treatment satisfaction and acceptance of treatment measured using measures developed for the study post-treatment, and at 6 months 10. Mediators and moderators analyzed using the following: 10.1. The Behavioral activation for depression scale-Short (BADS-SF) at baseline, during treatment, and post-treatment 10.2. The Skills of Cognitive Therapy (SoCT) at baseline, during treatment, and post-treatment 10.3. Program usage (single question, rating 0-4) during treatment 10.4. Implementation of CBT skills learned in intervention using a measure developed for the study at post-treatment and 6 months 10.5. Credibility Expectancy Questionnaire (CEQ) during treatment 10.6. Working Alliance Inventory-Short (WAI-S) during treatment 10.7. Causes for pre-mature intervention termination at termination

Countries

United States of America

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026