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

Adjustment Disorders Clinical Trial

Official title:

Internet-based Cognitive Behavior Therapy for Stress-related Disorders

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04797273
• Other study ID #: ICBT vs TAU for Stress
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 25, 2021
• Est. completion date: September 2024

Study information

• Verified date: December 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: September 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adjustment Disorders
• Exhaustion Disorder

Intervention

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.
• 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.

Locations

Country	Name	City	State
Sweden	Gustavsbergs Primary Care Center	Gustavsberg	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Region Stockholm

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)
Other	Credibility scale (C-scale)	week 3 only report of treatment credibility (scale range 0-50, higher score means higher credibility)	week 3
Other	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
Other	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
Other	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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.