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

Internet-based Cognitive Behavior Therapy for Stress-related Disorders

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Adjustment Disorders; Exhaustion Disorder
• Intervention / Treatment: Behavioral: Internet-based cognitive behavior therapy; Behavioral: Internet-based structured treatment-as-usual

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.

• Study Type: Interventional
• Enrollment (Actual): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Stockholm
    • Gustavsberg, Stockholm, Sweden, 13440
      • Gustavsbergs Primary Care Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Internet-based cognitive behavior therapy	Behavioral: 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.
Active Comparator: Internet-based structured treatment-as-usual	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shirom-Melamed Burnout Questionnaire (SMBQ)	Change in SMBQ at post-treatment and follow-ups compared to baseline (scale range 1-7, higher score means more symptoms)	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)	Change in MADRS-S at post-treatment and follow-ups compared to baseline (scale range 0-54, higher score means more symptoms)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Insomnia Severity Index (ISI)	Change in ISI at post-treatment and follow-ups compared to baseline (scale range 0-28, higher score means more symptoms)	Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up
Generalized Anxiety Disorder-7 (GAD-7)	Change in GAD-7 at post-treatment and follow-ups compared to baseline (scale range 0-21, higher score means more symptoms)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Sickness Questionnaire (SQ)	Change in SQ at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Self-rated Health (SRH)	Change in SRH at post-treatment and follow-ups compared to baseline (scale range 1-5, higher score means better self-rated health)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
World Health Organization's Disability Assessment Scale (WHODAS 2.0)	Change in WHODAS at post-treatment and follow-ups compared to baseline (scale range 0-100, higher score means more functional disability)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
EuroQol 5D (EQ5D 5L)	Change in EQ5D at post-treatment and follow-ups compared to baseline (The answers given in EQ-5D were combined to generate a utility score of health states ranging from 0 to 1, with 0 representing death and 1 representing full health) death and 1 representing full health	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Trimbos and Institute Medical Technology Assessment of Costs Questionnaire for Psychiatry (TIC-P)	The TIC-P enables estimation of costs by collecting information about participant resource utilization and costs related to production loss. Change in costs will be analysed at post-treatment and follow-ups compared to baseline.	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Physical Health Questionnaire (PHQ-15)	Change in PHQ-15 at post-treatment and follow-ups compared to baseline (scale range 0-30, higher score means more symptoms)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Cognitive impairment	Test-battery of cognitive tests measuring executive functions at post-treatment and follow-ups compared to baseline	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Sick leave	Sick leave data from the Microdata for Analysis of Social Security (MiDAS) registry. Analyzed as full-day equivalents.	1 year prior to baseline up to 2 years after baseline.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Karolinska Exhaustion Disorder Scale (KEDS)	Exploratory assessment of change at post-treatment and follow-ups compared to baseline (scale range 0-54, higher score means more symptoms)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Negative Events Questionnaire, 20-items (NEQ-20)	Post-treatment only report of negative events from treatment (scale range 0-80, higher score indicates more negative events)	week 12 (Post-treatment)
Credibility scale (C-scale)	week 3 only report of treatment credibility (scale range 0-50, higher score means higher credibility)	week 3
The Corona Virus Health Impact Survey -Short (CRISIS short)	Exploratory analysis of the impact of the Corona virus on worry and life style. Change in sum score of items 1,2,3,4,5,8 and 9 will be analyzed. Scale range 0-24. Higher scores mean higher impact of Corona.	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Subjective memory	Exploratory analysis of change in subjective memory at post-treatment and follow-ups compared to baseline (scale range 0-26, higher score means more subjective problems with memory)	Baseline, week 12 (post-treatment), 1-year follow-up, 2-year follow-up
Recovery Experience Questionnaire short version	Will be analyzed as potential mediator of treatment change. 7 items, scored 0-4. Scale-range 0-28. Higher scores indicate more recovery.	Baseline, weeks 3, 6, 9, 12 (post-treatment), 1-year follow-up, 2-year follow-up

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2021
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: March 11, 2021
• First Submitted That Met QC Criteria: March 11, 2021
• First Posted (Actual): March 15, 2021

Study Record Updates

• Last Update Posted (Actual): December 5, 2023
• Last Update Submitted That Met QC Criteria: December 4, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Internet-based treatment
• Additional Relevant MeSH Terms: Mental Disorders; Trauma and Stressor Related Disorders; Adjustment Disorders
• Other Study ID Numbers: ICBT vs TAU for Stress

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No