Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

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).

Study Overview

• Status: Completed
• Conditions: Anxiety Disorders; Major Depression; Primary Insomnia; Stress Disorders
• Intervention / Treatment: Behavioral: Continued self help CBT; Behavioral: Individual CBT

• Study Type: Interventional
• Enrollment (Actual): 396
• Phase: Phase 3

Contacts and Locations

Study Locations

• Sweden
  • Stockholm
    • Stockholm,, Stockholm, Sweden, 13440
      • Karolinska Institutet and Gustavsberg primary care center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Continued guided self help CBT; 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; After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.
Experimental: CBT individual therapy; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory cytokines	Change in inflammatory cytokines at post-treatment	Baseline, post-treatment (20 weeks)

Collaborators and Investigators

• Sponsor: Karolinska Institutet
• Collaborators: Region Stockholm

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: August 10, 2012
• First Submitted That Met QC Criteria: August 14, 2012
• First Posted (Estimate): August 17, 2012

Study Record Updates

• Last Update Posted (Estimate): October 18, 2016
• Last Update Submitted That Met QC Criteria: October 14, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Disease; Sleep Initiation and Maintenance Disorders; Anxiety Disorders
• Other Study ID Numbers: Self help CBT