Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy

• Sponsor: University of Southern Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT02796573
• Collaborator: (none)
• Enrollment: 76
• Location: 1
• Arms: 2
• Duration (Months): 51
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

Depression is a prevalent and disabling disorder with great cost to the individual and the society. Lately, the use of internet interventions as guided self-help has demonstrated remarkable results. However, certain shortcomings such as lack of personal adaptation has been identified.

The presents study aims to investigate the potential of blending Internet based interventions with face-to-face consultations using cognitive behavioural therapy (B-CBT). The main hypotheses are, that that B-CBT will be as clinically effective as TAU, and that it will be acceptable to patients and clinicians.

The study is designed as a two arm randomised non-inferiority trial comparing internet based B-CBT for depression to treatment as usual (TAU) defined as 12 sessions of face-to-face CBT.

Condition or Disease	Intervention/Treatment	Phase
Adult Depression	Behavioral: cognitive behavioural therapy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy: A Randomised Non-inferiority Trial
• Study Start Date: Mar 1, 2016
• Actual Primary Completion Date: May 1, 2019
• Actual Study Completion Date: Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: B-CBT 6 face-to-face consultations plus 6 online modules.	Behavioral: cognitive behavioural therapy
Active Comparator: Face-to-Face CBT 12 face-to-face consultations.	Behavioral: cognitive behavioural therapy

Outcome Measures

Primary Outcome Measures

1. Patient Health Questionnaire 9-item change [Change from Baseline, 3 months, 6 months, 12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Being 18 years of age or older.

• Meet Diagnostic and Statistic Manual of Mental Disorders 4th. edition (DSM-IV) diagnostic criteria for major depressive disorder as confirmed by the telephone administered Mini International Neuropsychiatric Interview version 5.0 (MINI)and a score of 5 or higher on the Patient Health Questionnaire nine items (PHQ-9).

Exclusion Criteria:

• Current high risk of suicide according to the MINI Interview section C.

• Co-morbid substance dependence, bipolar affective disorder, psychotic illness, obsessive compulsive disorder, as established at the MINI interview.

• Currently receiving psychological treatment for depression in primary or specialised mental health care

• Being unable to comprehend the spoken and written language of Danish.

• Not having access to a computer and fast Internet connection (i.e. broadband or comparable)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Centre for Telepsychiatry	Odense	Fyn	Denmark	5000

Sponsors and Collaborators

• University of Southern Denmark

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kim Mathiasen, Ph.D. fellow, University of Southern Denmark
• ClinicalTrials.gov Identifier: NCT02796573
• Other Study ID Numbers: S-20150150
• First Posted: Jun 10, 2016
• Last Update Posted: May 19, 2022
• Last Verified: May 1, 2022

• Keywords provided by Kim Mathiasen, Ph.D. fellow, University of Southern Denmark: blended care; CBT; B-CBT; depression
• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of May 19, 2022