NCT02535598

Brief Summary

This project aims to investigate factors that are important in affecting adherence in internet based Cognitive Behavior Therapy (CBT). It is hypothesized that two intervention-specific variables, Support and Content, are important factors and that maximizing the impact of these would result in improved adherence and potentially in the end also better outcome for participants in internet interventions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
169

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2014

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 3, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

August 28, 2015

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

May 13, 2016

Status Verified

May 1, 2016

Enrollment Period

8 months

First QC Date

August 3, 2015

Last Update Submit

May 12, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of treatment components completed

    Four weeks after treatment start

  • Number of behavioral prescriptions completed

    Four weeks after treatment start

Secondary Outcomes (1)

  • Perceived Stress Scale

    Baseline and four weeks after treatment start

Other Outcomes (1)

  • Perceived Stress Scale

    Baseline and eight weeks after treatment start

Study Arms (4)

Normal presentation

ACTIVE COMPARATOR

Standard internet based CBT presentation.

Behavioral: Normal presentation

Enhanced presentation

EXPERIMENTAL

Enhanced internet CBT presentation.

Behavioral: Enhanced presentation

Normal support

ACTIVE COMPARATOR

Standard internet based CBT support.

Behavioral: Normal support

Enhanced support

EXPERIMENTAL

Enhanced internet CBT support.

Behavioral: Enhanced support

Interventions

All the material will be presented as plain text.

Normal presentation

The material of the intervention is designed to be as appealing as possible with clear organization, animated presentations, ample illustrations, etc.

Enhanced presentation
Normal supportBEHAVIORAL

Participants receive semi-standardized support once a week and there will be no formal training or competence.

Normal support

Participants are offered daily support through the internet from trained therapists.

Enhanced support

Eligibility Criteria

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

You may qualify if:

  • Self-reported mild to moderate symptoms of stress or worry

You may not qualify if:

  • insufficient mastery of Swedish language
  • elevated symptoms of anxiety or depression that warrant clinical care
  • other medical or mental illness that need immediate clinical attention
  • no daily access to computer, internet and cell phone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uppsala University

Uppsala, Uppsala County, 75105, Sweden

Location

Related Publications (1)

  • Alfonsson S, Olsson E, Hursti T. Motivation and Treatment Credibility Predicts Dropout, Treatment Adherence, and Clinical Outcomes in an Internet-Based Cognitive Behavioral Relaxation Program: A Randomized Controlled Trial. J Med Internet Res. 2016 Mar 8;18(3):e52. doi: 10.2196/jmir.5352.

Study Officials

  • Timo Hursti, PhD

    Uppsala University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 3, 2015

First Posted

August 28, 2015

Study Start

May 1, 2014

Primary Completion

January 1, 2015

Study Completion

September 1, 2015

Last Updated

May 13, 2016

Record last verified: 2016-05

Locations