Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study

Uppsala University30 enrolled

Overview

This study comprises the pilot phase of a randomized controlled trial (NCT05085756) that will investigate the feasibility of a transdiagnostic CBT-based treatment for symptoms of depression and anxiety offered to Swedish university students. It will offer treatment to participants who have previously responded to a universal online mental health screen conducted in university setting (WHO-WMH-ICS survey). The pilot study initially has a prospective single-group design where 30 college students with elevated depressive and/or anxiety symptoms are enrolled in 8 weeks of therapist-guided CBT treatment via the Internet. All participants included will receive treatment. Mid-treatment, participants that are judged to be at risk of treatment failure will be randomized (1:1 ratio) to either continued treatment with no change, or to receive added therapist-support intended to enhance outcome. Pilot study outcomes include various aspects of feasibility: participant uptake, self-reported credibility and expectancy, adherence to treatment protocol and assessments, treatment satisfaction, potential adverse events, causes for premature termination of treatment, and procedures for providing additional therapist support to a subsample of participants after mid-treatment. Within-group effects for primary depression and anxiety measures will be quantified. A range of secondary measures are piloted for the subsequent randomized controlled trial. The assessment points for this study: Baseline; 8 points during treatment; post-treatment; 6-month follow-up; 12-month follow-up; 24 month follow up. Note. This study is retrospectively registered; this registration was completed prior to any outcome data-analyses.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * College/university student at institution of higher education in Sweden * Score 5-19 on the PHQ-9, and/or * Score ≥5 on the GAD-7 * Completed baseline assessment Exclusion Criteria: * Pharmacotherapy for mental health issue during the past 3 weeks) * Concurrent psychological treatment during the past 3 weeks * Mild levels of mental ill-health (under cut-off for primary outcome measures) * Severe levels of mental ill-health * Suicidal ideation or plans

Outcomes

Primary Outcomes

Treatment Credibility and expectancy Questionnaire (CEQ).

Credibility/expectancy. \[Feasibility and acceptability measure\]

Time frame: Baseline

Working Alliance Inventory - Short (WAI-S)

The WAI-S is scale measuring the participants perceived working alliance with their therapist. \[Feasibility and acceptability measure\]

Time frame: Mid-treatment (4 weeks)

The Client Satisfaction Questionnaire-8 (CSQ-8)

Treatment satisfaction \[Feasibility and acceptability measure\]

Time frame: Post-treatment (8 weeks)

Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation

Interest for intervention \[Feasibility and acceptability measure\]

Time frame: Baseline

Treatment completion/adherence.

Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. \[Feasibility and acceptability measure\]

Time frame: Post-treatment (8 weeks)

Assessment completion/adherence.

Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. \[Feasibility and acceptability measure\]

Time frame: Post-treatment (8 weeks)

Added therapist support.

Measured as % of participants who are randomized to receive additional therapist support for the remainder of the treatment period (weeks to 8).

Time frame: Mid-treatment (4 weeks)

Early treatment termination.

Measured as % of participants who decide to end treatment early. This includes reporting participants' reasons for early termination, where provided. \[Feasibility and acceptability measure\]

Time frame: Post-treatment (8 weeks)

Negative Effects Questionnaire (NEQ-20)

NEQ-20 investigate negative effects of psychological treatment. Total range is 0-80, with higher values representing a worse outcome. \[Feasibility and acceptability measure\]

Time frame: Mid-treatment (4 weeks)

Secondary Outcomes

Patient Health Questionnaire PHQ-9

Change in PHQ-9 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks).

Time frame: Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months

Generalized Anxiety Disorder scale (GAD-7)

Change in GAD-7 at post-treatment and follow-ups as compared to baseline. Primary endpoint: Change post-treatment (8 weeks).

Time frame: Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months

World Health Organization Well-being questionnaire (WHO-5).

Well-being

Time frame: Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months

Attitudes towards professional help (ATSPPHS)

Attitudes towards professional help

Time frame: Baseline; follow-up at 12 and 24 months

Diagnostic and Statistical Manual of Mental Disorders Cross-Cutting Symptom Measure (DSM-5 CCSM)

DSM-5 symptoms

Time frame: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months

Insomnia Severity Index (ISI)

Insomnia

Time frame: Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months

Behavioral Activation for Depression Scale (BADS-9

Behavioral Activation

Time frame: Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months

Skills of Cognitive Therapy (SoCT)

Cognitive Therapy skills

Transdiagnostic Internet Intervention to Improve Mental Health Among University Students: Pilot Study

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes