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

NCT ID: NCT04797273

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-25
• Study Completion Date: 2024-06-01

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.

Detailed Description

Non traumatic stress-related mental illness, in this study operationalized as adjustment disorder or exhaustion disorder, is highly prevalent in the general population and associated with high societal costs relating to productivity loss. Cognitive behavior therapy (CBT) is the most well-studied psychological treatment and has demonstrated promising effects in terms of symptom reduction. The overall evidence-base for CBT for these disorders is however fairly week and access to treatment is low. In a previously published randomized controlled trial we found that internet-based CBT can yield large effects on core symptoms of stress for these disorders. Delivering CBT via the internet has the large advantage of enabling increased accessibility as each therapist can have up to 80 patients in ongoing treatment. In the previously conducted trial we compared the treatment to a waitlist control and between-group comparisons of treatment effects were only done at post-treatment as the waitlist condition was crossed over to treatment after this time point. It is now therefore important to take the next step and investigate the effects of internet-based CBT in comparison to an active control condition. The primary aim of this study was to compare two internet-based treatments, CBT vs. structured treatment-as-usual, for adjustment disorder and exhaustion disorder.

Conditions

Adjustment Disorders; Exhaustion Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Internet-based cognitive behavior therapy

Group Type: EXPERIMENTAL

Internet-based cognitive behavior therapy

Intervention Type: 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 structured treatment-as-usual

Group Type: ACTIVE_COMPARATOR

Internet-based structured treatment-as-usual

Intervention Type: 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.

Interventions

Internet-based cognitive behavior therapy

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.

Intervention Type: BEHAVIORAL

Internet-based structured treatment-as-usual

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Erik Hedman

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Gustavsbergs Primary Care Center

Gustavsberg, Stockholm County, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 40334656 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 37550693 (View on PubMed)

Other Identifiers

ICBT vs TAU for Stress

Identifier Type: -

Identifier Source: org_study_id