Clinical depression Mental and Behavioural Disorders
Conditions
Interventions
This study aims to test the feasibility and efficacy of CURED, a self-administered procedure that has been developed by combining research on biases in depression with tried and tested techniques that
Sponsors
King's College London
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Adults scoring 14 or above on the Beck Depression Inventory-II (BDI-II)
Exclusion criteria
Exclusion criteria: 1. Having a mental or physical condition that impedes the completion of the study tasks (e.g., cancer, heart disease, stroke, dementia) 2. Currently receiving psychotherapy or having received psychotherapy within the last 2 months before participating in the study 3. If on psychotropic medication, having changed medication within the 1 month prior to participating in the study or expected to change medication during the study (changing the dose, dropping the medication, or starting to a new type of medication) 4. Screening positive on the Modified MINI Screen for Psychosis, Bipolar or OCD, and scoring 2 and higher on CAGE Questions Adapted to Include Drug Use (CAGE-AID) for alcohol and substance use 5. A previous head injury resulted in a loss of consciousness 6. Reporting suicidal intent according to the CSSRS at eligibility screening 7. Taking part in an interventional study aiming to improve mental health or cognitive functions during the time of participation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Depressive Symptoms will be measured using the Beck Depression Inventory-II (BDI-II) at 12 weeks post-randomisation follow-up (T2) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Feasibility and acceptability indicators: recruitment, drop-out, follow-up and randomisation rates, protocol length, the integrity of the double-blind procedure, and perceived harms, safety, and benefits will be measured using data collection during the study. In addition, feasibility will be measured using the Credibility and Expectancy Questionnaire (CEQ) at baseline (T0) and 6 weeks post-randomisation (T1). 2. Target mechanism (interpretation bias) will be measured using the Scrambled Sentences Task (SST) and Similarity Rating Test (SRT) at baseline (T0), 6 (T1) and 12 weeks (T2) post-randomisation 3. Depressive and anxious symptoms will be measured using the Beck Depression Inventory-II (BDI-II), Depression Anxiety Stress Scales – Short Form (DASS-21), Patient Health Questionnaire-9 (PHQ-9), and Generalized Anxiety Disorder-7 (GAD-7) at baseline (T0), 6 (T1) and 12 weeks (T2) post-randomisation 4. The following cognitive and psychosocial functioning measures will also be used at baseline (T0), 6 (T1) and 12 weeks (T2) post-randomisation: 4.1. Prospective Imagery Task (PIT) 4.2. Automatic Thoughts Questionnaire – Revised (ATQ-R) 4.3. Cognitive Distortions Scale (CDS) 4.4. Repetitive Thinking Questionnaire (RTQ-10) 4.5. Interpretation Inflexibility Task (IIT) (not measured at T2) 4.6. Recovery of Quality of Life-20 (ReQoL-20) 5. The dose–response relationship, target mechanism (interpretation bias) and depressive symptoms will be measured weekly after each weekly training session between the baseline (T0) and 6 weeks (T1): 5.1. Scrambled Sentences Task (SST) 5.2. Patient Health Questionnaire-9 (PHQ-9) 5.3. Visual Analogue Scale (VAS) for Mood | — |
Countries
England, United Kingdom, Wales
Contacts
Public ContactKaan Karamanli
Outcome results
None listed