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

NCT05509660 | Completed

• 1 other identifier: 2021-03599P
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psychological Disorder

Outcome Measures

Primary Outcomes (9)

• Treatment Credibility and expectancy Questionnaire (CEQ).

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

  Baseline

• Working Alliance Inventory - Short (WAI-S)

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

  Mid-treatment (4 weeks)

• The Client Satisfaction Questionnaire-8 (CSQ-8)

  Treatment satisfaction \[Feasibility and acceptability measure\]

  Post-treatment (8 weeks)

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

  Interest for intervention \[Feasibility and acceptability measure\]

  Baseline

• Treatment completion/adherence.

  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.

  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.

  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.

  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)

  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 Outcomes (16)

• Patient Health Questionnaire PHQ-9

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

• Generalized Anxiety Disorder scale (GAD-7)

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

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

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

• Attitudes towards professional help (ATSPPHS)

  Baseline; follow-up at 12 and 24 months

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

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

Study Arms (2)

Therapist-guided internet-based CBT treatment with increased therapist support

EXPERIMENTAL

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+

Therapist-guided internet-based CBT treatment with standard therapist-support

ACTIVE COMPARATOR

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

Interventions

PUMA BEHAVIORAL

Transdiagnostic CBT

Also known as: Transdiagnostic CBT

Therapist-guided internet-based CBT treatment with standard therapist-support

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uppsala University: lead
• Linkoeping University: collaborator
• Malmö University: collaborator
• Stockholm University: collaborator
• Karolinska Institutet: collaborator

Study Sites (1)

Uppsala University

Uppsala, 75105, Sweden

Location

Related Publications (2)

• Andersson C, Bendtsen M, Lindfors P, Molander O, Lindner P, Topooco N, Engstrom K, Berman AH. Does the management of personal integrity information lead to differing participation rates and response patterns in mental health surveys with young adults? A three-armed methodological experiment. Int J Methods Psychiatr Res. 2021 Dec;30(4):e1891. doi: 10.1002/mpr.1891. Epub 2021 Aug 21.

  PMID: 34418224 BACKGROUND

• Topooco N, Lindner P, Andersson C, Lindfors P, Molander O, Kraepelien M, Sundstrom C, Vlaescu G, Andersson G, Bendtsen M, Berman AH. Personalized Transdiagnostic Cognitive Behavior Therapy With Midtreatment Stepped Care to Improve Mental Health Among University Students in Sweden: Feasibility Study for a Randomized Controlled Trial. JMIR Form Res. 2026 Jan 15;10:e68698. doi: 10.2196/68698.

  PMID: 41538789 DERIVED

MeSH Terms

Conditions

Mental Disorders

Study Officials

• Anne H Berman, PhD

  Uppsala University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 22, 2022
• Study Start: October 6, 2021
• Primary Completion: January 6, 2022
• Study Completion: December 31, 2023
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)