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NCT Number: NCT05509660

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University

Uppsala, 75105, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PUMA+

Behavioral

Transdiagnostic CBT

Puma

Behavioral

Transdiagnostic CBT

Other names: Transdiagnostic CBT

Primary outcomes

  1. Treatment Credibility and expectancy Questionnaire (CEQ).

    Time frame: Baseline

    Credibility/expectancy. [Feasibility and acceptability measure]

  2. Working Alliance Inventory - Short (WAI-S)

    Time frame: Mid-treatment (4 weeks)

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

  3. The Client Satisfaction Questionnaire-8 (CSQ-8)

    Time frame: Post-treatment (8 weeks)

    Treatment satisfaction [Feasibility and acceptability measure]

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

    Time frame: Baseline

    Interest for intervention [Feasibility and acceptability measure]

  5. Treatment completion/adherence.

    Time frame: Post-treatment (8 weeks)

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

  6. Assessment completion/adherence.

    Time frame: Post-treatment (8 weeks)

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

  7. Added therapist support.

    Time frame: Mid-treatment (4 weeks)

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

  8. Early treatment termination.

    Time frame: Post-treatment (8 weeks)

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

  9. Negative Effects Questionnaire (NEQ-20)

    Time frame: Mid-treatment (4 weeks)

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

Secondary outcomes

  1. Patient Health Questionnaire PHQ-9

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

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

  2. Generalized Anxiety Disorder scale (GAD-7)

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

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

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

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

    Well-being

  4. Attitudes towards professional help (ATSPPHS)

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

    Attitudes towards professional help

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

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

    DSM-5 symptoms

  6. Insomnia Severity Index (ISI)

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

    Insomnia

  7. Behavioral Activation for Depression Scale (BADS-9

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

    Behavioral Activation

  8. Skills of Cognitive Therapy (SoCT)

    Time frame: Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up

    Cognitive Therapy skills

  9. World Health Organization Quality of Life Scale (WHOQOL-Bref).

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

    Quality of Life

  10. Alcohol Use Disorders Identification Test - Consumption (AUDIT-C).

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

    Alcohol Use

  11. Rosenberg Self-Esteem Scale (RESES)

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

    Self-Esteem

  12. Connor-Davidson Resilience Scale.

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

    Resilience

  13. Difficulties in Emotion-Regulation Scale (DERS-16).

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

    Emotion-Regulation

  14. Penn-State Worry Questionnaire (PSWQ)

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

    Worry

  15. Big Five Inventory-10 (BFI-10)

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

    Personality

  16. Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P)

    Time frame: Baseline; follow-up at 6, 12, and 24 months

    Healthcare consumption and productivity loss

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Karolinska Institutet
  • Linkoeping University
  • Malmö University
  • Stockholm University

Registry information

Official study title

E-health Interventions for Common Mental Health Problems Among University Students in Sweden: Pilot Study of Transdiagnostic Internet-based Psychological Treatment

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Aug 22, 2022
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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