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

October 10, 2023 updated by: Uppsala University

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

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 Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 11630
        • Uppsala University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Therapist-guided internet-based CBT treatment with increased therapist support

Intervention/treatment: Behavioral: 'PUMA+'

8-week transdiagnostic CBT with therapist-support. One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules (acceptance; maintenance of skills learned). From mid-treatment onwards, participants will be offered increased therapist support.
Behavioral: PUMA+
Transdiagnostic CBT
Active Comparator: Therapist-guided internet-based CBT treatment with standard therapist-support

Intervention/treatment: Behavioral: 'PUMA' Intervention/treatment: Behavioral: 'PUMA'

8-week transdiagnostic CBT with therapist support. One psychoeducation module followed by two transdiagnostic modules tailored to primary depression or anxiety symptoms, followed by three participant-choice modules, and ending with two transdiagnostic modules (acceptance; maintenance of skills learned).
Behavioral: PUMA
Transdiagnostic CBT
Other Names:
  • Transdiagnostic CBT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment Credibility and expectancy Questionnaire (CEQ).
Time Frame: Baseline
Credibility/expectancy. [Feasibility and acceptability measure]
Baseline
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]
Mid-treatment (4 weeks)
The Client Satisfaction Questionnaire-8 (CSQ-8)
Time Frame: Post-treatment (8 weeks)
Treatment satisfaction [Feasibility and acceptability measure]
Post-treatment (8 weeks)
Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation
Time Frame: Baseline
Interest for intervention [Feasibility and acceptability measure]
Baseline
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]
Post-treatment (8 weeks)
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]
Post-treatment (8 weeks)
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).
Mid-treatment (4 weeks)
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]
Post-treatment (8 weeks)
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]
Mid-treatment (4 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months
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).
Baseline, during treatment (weekly), post-treatment (8 weeks), follow-up at 6, 12, and 24 months
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
Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Attitudes towards professional help (ATSPPHS)
Time Frame: Baseline; follow-up at 12 and 24 months
Attitudes towards professional help
Baseline; follow-up at 12 and 24 months
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
Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Insomnia Severity Index (ISI)
Time Frame: Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Insomnia
Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
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
Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Skills of Cognitive Therapy (SoCT)
Time Frame: Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up
Cognitive Therapy skills
Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up
World Health Organization Quality of Life Scale (WHOQOL-Bref).
Time Frame: Baseline; follow-up at 12 and 24 months
Quality of Life
Baseline; follow-up at 12 and 24 months
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
Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Rosenberg Self-Esteem Scale (RESES)
Time Frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Self-Esteem
Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Connor-Davidson Resilience Scale.
Time Frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Resilience
Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Difficulties in Emotion-Regulation Scale (DERS-16).
Time Frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Emotion-Regulation
Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Penn-State Worry Questionnaire (PSWQ)
Time Frame: Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Worry
Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months
Big Five Inventory-10 (BFI-10)
Time Frame: Baseline; follow-up at 12 and 24 months
Personality
Baseline; follow-up at 12 and 24 months
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
Baseline; follow-up at 6, 12, and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Karolinska Institutet
Linkoeping University
Malmö University
Stockholm University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 6, 2021

Primary Completion (Actual)

January 6, 2022

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 19, 2022

First Posted (Actual)

August 22, 2022

Study Record Updates

Last Update Posted (Actual)

October 11, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-03599P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Outcome data will be shared as appropriate, but primarily within the WHO-WMH-ICS consortium.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Psychological Disorder

Clinical Trials on PUMA+

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sweden

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe