Adult Depression Clinical Trial
Official title:
Blended Cognitive Behavioural Therapy Versus Face-to-face Cognitive Behavioural Therapy: A Randomised Non-inferiority Trial
| NCT number | NCT02796573 |
| Other study ID # | S-20150150 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | March 2016 |
| Est. completion date | June 2020 |
| Verified date | May 2022 |
| Source | University of Southern Denmark |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 76 |
| Est. completion date | June 2020 |
| Est. primary completion date | May 1, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Centre for Telepsychiatry | Odense | Fyn |
| Lead Sponsor | Collaborator |
|---|---|
| University of Southern Denmark |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Patient Health Questionnaire 9-item change | Change from Baseline, 3 months, 6 months, 12 months |