Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

Anxiety Disorders Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01667822
• Other study ID #: Self help CBT
• Status: Completed
• Phase: Phase 3
• First received: August 10, 2012
• Last updated: October 14, 2016
• Start date: August 2012
• Est. completion date: December 2015

Study information

• Verified date: October 2016
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Interventional

Clinical Trial Summary

Background: Studies show that about 1 out of 3 patients in Primary Care suffer primarily from mental health disorders, such as anxiety disorders and depression. Cognitive behavior therapy (CBT) has been shown to be an effective treatment of these disorders. Despite the strong evidence for CBT there is a lack of evidence-based psychological treatment in primary care. For various reasons, the progress of research has not affected clinical practice. For successful implementation of CBT in primary care cost-effective therapies, access to therapists with proper training and supervision, evidence-based manuals and management that support the implementation is needed.

Aim: The aim of this trial is to evaluate a stepped care model with CBT in primary care. All patients are first treated with self-help CBT (N = 400). Patients that do not improve after treatment (9 weeks) are randomized to individual CBT or continued self-help treatment. Based on published studies 2/3 is expected to be improved after self-help and therefore do not undergo randomization. 1/3 (n = 133) who didn´t respond to treatment is randomized to individual CBT (N = 67) or continued self-help treatment (N = 67).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 396
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Have an anxiety disorder diagnosis (obsessive compulsive disorder, social phobia, panic disorder, generalized anxiety disorder), or/and major depression, or/and maladaptive stress reaction, or/and primary insomnia Clinician severity rating scale 2-6

Exclusion Criteria:

• A higher score than 6 on the Clinician severity rating scale

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Depressive Disorder, Major
• Disease
• Major Depression
• Primary Insomnia
• Sleep Initiation and Maintenance Disorders
• Stress Disorders
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Continued self help CBT
After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.
• Individual CBT
After the initial face of self help CBT, patients in this arm receive individual CBT. The cognitive behavior therapy used in the study will be based on the protocols with best empirical support.The therapy is delivered by the same psychologist as in the first face and the second face builds on the learning's from the first face.

Locations

Country	Name	City	State
Sweden	Karolinska Institutet and Gustavsberg primary care center	Stockholm,	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Stockholm County Council, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Inflammatory cytokines	Change in inflammatory cytokines at post-treatment	Baseline, post-treatment (20 weeks)
Primary	Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population	Absolute improvement, i.e., symptom level below pre-established cut-offs at 9 weeks, 20 weeks, 26 week follow-up, and 52 week follow-up compared to baseline.	9 weeks	No
Primary	Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population	Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population	20 weeks	No
Primary	Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population	Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population	26 weeks	No
Primary	Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population	Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population	52 weeks	No
Secondary	Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)	Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Work ability index (WAI)	Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Insomnia Severity Index (ISI)	Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Health Anxiety Inventory (HAI)	Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Perceived Stress Scale (PSS)	Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)	Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Quality of Life Inventory (QOLI)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up	No
Secondary	EuroQol-5 dimension (EQ5D)	Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Sheehan Disability Scales (SDS)	Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Self-rated health 5 (SRH-5)	Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Obsessive Compulsive Inventory-Revised (OCI-R)	Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Liebowitz Social Anxiety Scale Self-report (LSAS-SR)	Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Panic Disorder Severity Scale Self-rated (PDSS-SR)	Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No
Secondary	Penn-State Worry Questionnaire (PSWQ)	Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.	Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up	No