Evaluating the Effectiveness of an Online Cognitive Behavioral Therapy Program for University Students With Depression and/or Anxiety (VIVIM)

University Rovira i Virgili

Status: Enrolling

Conditions: Anxiety and Depression

Treatments: Other: Counseling; Behavioral: VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo)

Study type: Interventional

Funder types: Other

Identifiers

NCT07246239

CEIPSA-2024-PR-0023 Full RCT

2023 Benes 00023 (Other Grant/Funding Number)

Details and patient eligibility

About

The goal of this clinical trial is to learn if an Internet-based self-help program called VIVIM can help university students with depression and/or anxiety. The main question we want to answer is:

* Does the VIVIM program help participants to feel less depressed and/or anxious? We will compare the VIVIM program with the usual psychological support that university counselling services offer to students.

Participants will:

• Be randomly assigned to either use the VIVIM program or receive usual help from university's counselling service.
• Fill out online questionnaires three times: at the beginning, 10 weeks and 6 months after being assigned either the VIVIM program or usual care.

Enrollment: 108 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• To be enrolled as an undergraduate or postgraduate at of the participating Spanish universities.
• To report at least moderate symptoms of depression (PHQ>o= 10) and/or anxiety (GAD-7>o= 10).

Exclusion criteria

• To self-report having been diagnosed with bipolar and/or psychotic disorder.
• To report to be currently receiving psychotherapy/counselling and/or pharmacological treatment for emotional problems.
• To be unable to read, speak or understand Spanish.
• To be at risk of suicide.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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108 participants in 2 patient groups

Internet-based CBT program

Experimental group

Description:

This 10-week program consists of 10 modules. Throughout the program, participants progress at their own pace. They have the opportunity to attend two individual support sessions (at the beginning and midway through the program) as well as in weekly group support designed to address questions and reinforce learning. These sessions are conducted via videoconference. Participants also receive weekly automated email remainders and can contact the team via email at any time. This program is an adaptation of Overcoming Low mood and Depresion: A Five Areas Approach.

Treatment:

Behavioral: VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo)

Treatment as usual

Active Comparator group

Description:

Treatment as usual involves referral to the counseling service offered by the university to its students.

Treatment:

Other: Counseling