Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

This study is currently recruiting participants.
Verified February 2014 by Karolinska Institutet
Sponsor:
Collaborator:
Stockholm County Council, Sweden
Information provided by (Responsible Party):
Erik Hedman, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01667822
First received: August 10, 2012
Last updated: February 7, 2014
Last verified: February 2014
  Purpose

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).


Condition Intervention Phase
Anxiety Disorders
Major Depression
Stress Disorders
Primary Insomnia
Behavioral: Continued self help CBT
Behavioral: Individual CBT
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Clinician Severity Rating (CSR) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in CSR at post-treatment, 26 week follow-up, and 52 week follow-up compared to baseline.


Secondary Outcome Measures:
  • Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up

  • Work ability index (WAI) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up

  • Insomnia Severity Index (ISI) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up

  • Health Anxiety Inventory (HAI) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up

  • Perceived Stress Scale (PSS) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up

  • Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up

  • Quality of Life Inventory (QOLI) [ Time Frame: Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up

  • EuroQol-5 dimension (EQ5D) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up

  • Sheehan Disability Scales (SDS) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up

  • Self-rated health 5 (SRH-5) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up

  • Obsessive Compulsive Inventory-Revised (OCI-R) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  • Liebowitz Social Anxiety Scale Self-report (LSAS-SR) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  • Panic Disorder Severity Scale Self-rated (PDSS-SR) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

  • Penn-State Worry Questionnaire (PSWQ) [ Time Frame: Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up ] [ Designated as safety issue: No ]
    Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.


Estimated Enrollment: 400
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01667822

Contacts
Contact: Erik Hedman, PhD 123 40 000 ext +468 kire.hedman@ki.se
Contact: Sigrid Salomonsson, MSc 718 68 83 ext +468 sigrid.salomonsson@sll.se

Locations
Sweden
Karolinska Institutet and Gustavsberg primary care center Recruiting
Stockholm,, Stockholm, Sweden, 13440
Contact: Erik Hedman, PhD    123 40 000 ext +468    kire.hedman@ki.se   
Contact: Sigrid Salomonsson, MSc    7186883 ext +468    sigrid.salomonsson@sll.se   
Sponsors and Collaborators
Karolinska Institutet
Stockholm County Council, Sweden
  More Information

No publications provided

Responsible Party: Erik Hedman, Principal investigator, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01667822     History of Changes
Other Study ID Numbers: Self help CBT
Study First Received: August 10, 2012
Last Updated: February 7, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Anxiety Disorders
Depression
Depressive Disorder
Sleep Initiation and Maintenance Disorders
Stress Disorders, Traumatic
Depressive Disorder, Major
Mental Disorders
Behavioral Symptoms
Mood Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on April 17, 2014