NCT01667822

Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 396 (actual)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Anxiety Disorders
• Major Depression
• Stress Disorders
• Primary Insomnia

Interventions

Type	Name	Description
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.
BEHAVIORAL	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.

Timeline

• Start date: 2012-08-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2012-08-17
• Last updated: 2016-10-18

Locations

1 site across 1 country: Sweden