Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

NCT01667822 | Completed Phase 3

• 1 other identifier: Self help CBT
• Study Type: interventional
• Target: 396
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• 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

Secondary Outcomes (14)

• Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)

  Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

• Work ability index (WAI)

  Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

• Insomnia Severity Index (ISI)

  Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

• Health Anxiety Inventory (HAI)

  Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

• Perceived Stress Scale (PSS)

  Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up

Other Outcomes (1)

• Inflammatory cytokines

  Baseline, post-treatment (20 weeks)

Study Arms (2)

Continued guided self help CBT

ACTIVE COMPARATOR

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

Behavioral: Continued self help CBT

CBT individual therapy

EXPERIMENTAL

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.

Behavioral: Individual CBT

Interventions

Continued self help CBT BEHAVIORAL

After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.

Continued guided self help CBT

Individual CBT BEHAVIORAL

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.

CBT individual therapy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator

Study Sites (1)

Karolinska Institutet and Gustavsberg primary care center

Stockholm, Stockholm County, 13440, Sweden

Location

MeSH Terms

Conditions

Anxiety Disorders; Depressive Disorder, Major; Stress Disorders, Traumatic; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Mental Disorders; Depressive Disorder; Mood Disorders; Trauma and Stressor Related Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: August 10, 2012
• First Posted: August 17, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: October 18, 2016

Record last verified: 2016-10

Locations

SE (1)