Psychological Disorder
Conditions
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.
Interventions
BEHAVIORALPUMA+
Transdiagnostic CBT
BEHAVIORALPUMA
Transdiagnostic CBT
Sponsors
Linkoeping University
Malmö University
Stockholm University
Karolinska Institutet
Uppsala University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Credibility and expectancy Questionnaire (CEQ). | Baseline | Credibility/expectancy. \[Feasibility and acceptability measure\] |
| Working Alliance Inventory - Short (WAI-S) | Mid-treatment (4 weeks) | The WAI-S is scale measuring the participants perceived working alliance with their therapist. \[Feasibility and acceptability measure\] |
| The Client Satisfaction Questionnaire-8 (CSQ-8) | Post-treatment (8 weeks) | Treatment satisfaction \[Feasibility and acceptability measure\] |
| Treatment interest/uptake. Measured in terms of % participants who responded to the study invitation | Baseline | Interest for intervention \[Feasibility and acceptability measure\] |
| Treatment completion/adherence. | Post-treatment (8 weeks) | Adherence to the treatment protocol. Measured in terms of % completed modules and % of completed skills practices. \[Feasibility and acceptability measure\] |
| Assessment completion/adherence. | Post-treatment (8 weeks) | Adherence to assessment plan (% missing data). Measured in terms of % completed measures at post-treatment. \[Feasibility and acceptability measure\] |
| Added therapist support. | 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). |
| Early treatment termination. | Post-treatment (8 weeks) | Measured as % of participants who decide to end treatment early. This includes reporting participants' reasons for early termination, where provided. \[Feasibility and acceptability measure\] |
| Negative Effects Questionnaire (NEQ-20) | 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
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | Baseline; mid-treatment (4 weeks); post-treatment (8 weeks); follow-up at 6, 12, and 24 months | Insomnia |
| 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 | DSM-5 symptoms |
| Patient Health Questionnaire PHQ-9 | 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). |
| Generalized Anxiety Disorder scale (GAD-7) | 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). |
| World Health Organization Well-being questionnaire (WHO-5). | Baseline; During treatment (weekly); post-treatment (8 weeks); follow-up at 6, 12, and 24 months | Well-being |
| Attitudes towards professional help (ATSPPHS) | Baseline; follow-up at 12 and 24 months | Attitudes towards professional help |
| Behavioral Activation for Depression Scale (BADS-9 | Baseline; mid-treatment (week 4); post-treatment (8 weeks); follow-up at 6, 12, and 24 months | Behavioral Activation |
| Skills of Cognitive Therapy (SoCT) | Baseline; mid-treatment (4 weeks); post-treatment (8weeks); 24-month follow-up | Cognitive Therapy skills |
| World Health Organization Quality of Life Scale (WHOQOL-Bref). | Baseline; follow-up at 12 and 24 months | Quality of Life |
| Alcohol Use Disorders Identification Test - Consumption (AUDIT-C). | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | Alcohol Use |
| Rosenberg Self-Esteem Scale (RESES) | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | Self-Esteem |
| Connor-Davidson Resilience Scale. | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | Resilience |
| Difficulties in Emotion-Regulation Scale (DERS-16). | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | Emotion-Regulation |
| Penn-State Worry Questionnaire (PSWQ) | Baseline; post-treatment (8 weeks); follow-up at 6, 12, and 24 months | Worry |
| Big Five Inventory-10 (BFI-10) | Baseline; follow-up at 12 and 24 months | Personality |
| Healthcare consumption and productivity loss in patients with a psychiatric disorder (TIC-P) | Baseline; follow-up at 6, 12, and 24 months | Healthcare consumption and productivity loss |
Countries
Sweden
Outcome results
None listed