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Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

Primary Purpose

Anxiety Disorders, Major Depression, Stress Disorders

Status
Completed
Phase
Phase 3
Locations
Sweden
Study Type
Interventional
Intervention
Continued self help CBT
Individual CBT
Sponsored by
Karolinska Institutet
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anxiety Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Karolinska Institutet and Gustavsberg primary care center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Continued guided self help CBT

CBT individual therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
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
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
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

Secondary Outcome Measures

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
Work ability index (WAI)
Change in WAI at post-treatment, 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
Health Anxiety Inventory (HAI)
Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
Perceived Stress Scale (PSS)
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)
Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
Quality of Life Inventory (QOLI)
Baseline, post-treatment (variable depending on disorder), 26 week 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
Sheehan Disability Scales (SDS)
Baseline, post-treatment (variable depending on disorder), 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
Obsessive Compulsive Inventory-Revised (OCI-R)
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)
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)
Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Penn-State Worry Questionnaire (PSWQ)
Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.

Full Information

First Posted
August 10, 2012
Last Updated
October 14, 2016
Sponsor
Karolinska Institutet
Collaborators
Region Stockholm
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1. Study Identification

Unique Protocol Identification Number
NCT01667822
Brief Title
Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Region Stockholm

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety Disorders, Major Depression, Stress Disorders, Primary Insomnia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
396 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Continued guided self help CBT
Arm Type
Active Comparator
Arm Description
Continued guided self help CBT. Participants will receive CBT through self-help books with minimal therapist contact (3 sessions in total).
Arm Title
CBT individual therapy
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Continued self help CBT
Intervention Description
After the initial Guided self help, patients in this arm continue the same self help program with 1 additional guiding session.
Intervention Type
Behavioral
Intervention Name(s)
Individual CBT
Intervention 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.
Primary Outcome Measure Information:
Title
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Description
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.
Time Frame
9 weeks
Title
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Description
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Time Frame
20 weeks
Title
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Description
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Time Frame
26 weeks
Title
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Description
Absolute improvement in disorder specific symptoms defined as closer to healthy than to clinical population or 2 standard deviations from clinical population
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Montgomery-Åsberg Depression Rating Scale-Self-report (MADRS-S)
Description
Change in MADRS-S at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Work ability index (WAI)
Description
Change in WAI at post-treatment, 26 week follow-up, 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Insomnia Severity Index (ISI)
Description
Change in ISI at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Health Anxiety Inventory (HAI)
Description
Change in HAI at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Perceived Stress Scale (PSS)
Description
Change in PSS at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Trimbos and Institute of Technology Cost Questionnaire for Psychiatry (TIC-P)
Description
Change in TIC-P at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Quality of Life Inventory (QOLI)
Description
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 feel follow-up, 52 week follow-up
Title
EuroQol-5 dimension (EQ5D)
Description
Change in EQ5D at post-treatment, 26 week follow-up, and 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Sheehan Disability Scales (SDS)
Description
Baseline, post-treatment (variable depending on disorder), 26 week follow-up, 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Self-rated health 5 (SRH-5)
Description
Change in SRH-5 at post-treatment, 26 week follow-up and 52 week follow-up
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Obsessive Compulsive Inventory-Revised (OCI-R)
Description
Change in OCI-R at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Liebowitz Social Anxiety Scale Self-report (LSAS-SR)
Description
Change in LSAS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Panic Disorder Severity Scale Self-rated (PDSS-SR)
Description
Change in PDSS-SR at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Title
Penn-State Worry Questionnaire (PSWQ)
Description
Change in PSWQ at post-treatment, 26 week follow-up, and 52 week follow-up. Disorder specific.
Time Frame
Baseline, post-treatment (20 weeks), 26 week follow-up, 52 week follow-up
Other Pre-specified Outcome Measures:
Title
Inflammatory cytokines
Description
Change in inflammatory cytokines at post-treatment
Time Frame
Baseline, post-treatment (20 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Karolinska Institutet and Gustavsberg primary care center
City
Stockholm,
State/Province
Stockholm
ZIP/Postal Code
13440
Country
Sweden

12. IPD Sharing Statement

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Cognitive Behavioral Therapy, Guided Self Help Versus Individual Therapy

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