NCT01591720

Brief Summary

A tailored Internet-based cognitive-behavioural intervention is tested within a primary care clinic. Weekly measures of symptoms of depression and anxiety are obtained. Significant within-group effects are expected.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for not_applicable depression

Timeline
Completed

Started Sep 2010

Shorter than P25 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 18, 2012

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 4, 2012

Completed
Last Updated

May 4, 2012

Status Verified

May 1, 2012

Enrollment Period

11 months

First QC Date

April 18, 2012

Last Update Submit

May 2, 2012

Conditions

Outcome Measures

Primary Outcomes (6)

  • Patient Health Questionnaire 9 (PHQ-9)

    2 weeks before treatment starts

  • Patient Health Questionnaire 9 (PHQ-9)

    Weekly measures during treatment (for up to 16 weeks)

  • Patient Health Questionnaire 9 (PHQ-9)

    At treatment termination (after a maximum of 16 weeks)

  • Generalised Anxiety Disorder Assessment 7 (GAD-7)

    2 weeks before treatment starts

  • Generalised Anxiety Disorder Assessment 7 (GAD-7)

    Weekly measures during treatment (for up to 16 weeks)

  • Generalised Anxiety Disorder Assessment 7 (GAD-7)

    At treatment termination (after a maximum of 16 weeks)

Study Arms (1)

Tailored Internet-delivered CBT

EXPERIMENTAL

The intervention is delivered within a primary care clinic.

Behavioral: Tailored Internet-based CBT for depression and anxiety

Interventions

This Internet-based CBT intervention contains 8-10 text-based self-help modules in which 4 modules are fixed (the first three and the last) and the rest are "prescribed" following the diagnostic interview. These modules contain material on panic disorder, social phobia, stress management, assertiveness training, concentration, relaxation among other things.

Tailored Internet-delivered CBT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Symptoms of depression and anxiety

You may not qualify if:

  • Severe depression (based on interview)
  • Severe psychiatric condition (e.g. psychosis or bipolar disorder)
  • Suicidal (measured in diagnostic interview)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Linköping University, Department of Behavioral Sciences and Learning

Linköping, 58183, Sweden

Location

MeSH Terms

Conditions

DepressionAnxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • Gerhard Andersson, PhD

    Department of Behavioral Sciences and Learning, Linköping University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical Psychology

Study Record Dates

First Submitted

April 18, 2012

First Posted

May 4, 2012

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

May 4, 2012

Record last verified: 2012-05

Locations