Internet-based CBT vs. TAU for Stress-related Disorders

NCT04797273 | Completed

• 1 other identifier: ICBT vs TAU for Stress
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Stress-related mental illness is common and one of the main causes of sick leave in Sweden. Cognitive behavior therapy (CBT) is a promising treatment, but access to treatment is low. In a previously conducted study, we found that internet-based CBT in comparison to a waitlist control group was effective in reducing symptoms of stress. The aim of the present study is to take the next step and compare Internet-based CBT for stress-related disorders to an active control condition.

Conditions

Adjustment Disorders; Exhaustion Disorder

Keywords

Internet-based treatment; Randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Perceived Stress Scale (PSS-10)

  Change in PSS at post-treatment and follow-ups compared to baseline (scale range 0-40, higher score means more symptoms)

  Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

Secondary Outcomes (12)

• Shirom-Melamed Burnout Questionnaire (SMBQ)

  Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

• Montgomery-Åsberg Depression Rating Scale Self-report (MADRS-S)

  Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up

• Insomnia Severity Index (ISI)

  Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

• Generalized Anxiety Disorder-7 (GAD-7)

  Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up

• Sickness Questionnaire (SQ)

  Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up

Other Outcomes (6)

• Karolinska Exhaustion Disorder Scale (KEDS)

  Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up

• Negative Events Questionnaire, 20-items (NEQ-20)

  week 12 (Post-treatment)

• Credibility scale (C-scale)

  week 3

Study Arms (2)

Internet-based cognitive behavior therapy

EXPERIMENTAL

Behavioral: Internet-based cognitive behavior therapy

Internet-based structured treatment-as-usual

ACTIVE COMPARATOR

Behavioral: Internet-based structured treatment-as-usual

Interventions

Internet-based cognitive behavior therapy BEHAVIORAL

12 week Internet-based cognitive behavior therapy, delivered via an online treatment platform. The treatment includes components such as exercises in conducting recuperating activities, methods to improve sleep, exposure, and behavioral activation. The treatment content is provided through written texts, images and audiofiles in the treatment platform. The participant has access to a therapist who provides support throughout the treatment via asynchronous text messages.

Internet-based cognitive behavior therapy

Internet-based structured treatment-as-usual BEHAVIORAL

This is a 12-week treatment, delivered via an online treatment platform. The treatment components in this treatment are designed to be similar to what is typically provided in primary care to these patients and includes information about stress and how different factors such as eating habits, physical exercise, and alcohol can contribute to stress problems. The treatment content is provided through written texts, images and audiofiles in the treatment platform. The participant has access to a therapist who provides support throughout the treatment via asynchronous text messages.

Internet-based structured treatment-as-usual

Eligibility Criteria

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

You may qualify if:

• primary adjustment disorder or exhaustion disorder
• regular access to a computer and to the internet
• ability to read and write in swedish

You may not qualify if:

• substance abuse in the past 6 months
• lifetime psychosis or bipolar disorder
• suicide risk
• initiated or changed psychopharmacological treatment for depression or anxiety in the past month
• concurrent psychological treatment
• cognitive behavior therapy for stress-related symptoms in the past year.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Gustavsbergs Primary Care Center

Gustavsberg, Stockholm County, 13440, Sweden

Location

Related Publications (2)

• Sennerstam V, Franke Foyen L, Kontio E, Svardman F, Lekander M, Lindsater E, Hedman-Lagerlof E. Internet-Delivered Treatment for Stress-Related Disorders: A Randomized Controlled Superiority Trial of Cognitive Behavioral Therapy versus General Health Promotion. Psychother Psychosom. 2025;94(4):273-288. doi: 10.1159/000546221. Epub 2025 May 7.

  PMID: 40334656 DERIVED

• Franke Foyen L, Sennerstam V, Kontio E, Lekander M, Hedman-Lagerlof E, Lindsater E. Objective cognitive functioning in patients with stress-related disorders: a cross-sectional study using remote digital cognitive testing. BMC Psychiatry. 2023 Aug 7;23(1):565. doi: 10.1186/s12888-023-05048-5.

  PMID: 37550693 DERIVED

MeSH Terms

Conditions

Adjustment Disorders

Condition Hierarchy (Ancestors)

Trauma and Stressor Related Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 11, 2021
• First Posted: March 15, 2021
• Study Start: March 25, 2021
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

SE (1)