Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

Karolinska Institute

Status and phase: Completed; Phase 3

Conditions: Major Depression; Anxiety Disorders; Stress Disorders; Primary Insomnia

Treatments: Behavioral: Continued self help CBT; Behavioral: Individual CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT01667822

Self help CBT

Details and patient eligibility

About

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).

Enrollment: 396 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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396 participants in 2 patient groups

Continued guided self help CBT

Active Comparator group

Description:

Continued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total).

Treatment:

Behavioral: Continued self help CBT

CBT individual therapy

Experimental group

Description:

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.

Treatment:

Behavioral: Individual CBT