Depression Mental and Behavioural Disorders
Conditions
Interventions
PROJECT DESIGN AND SETTING
This project will follow a randomised multiple baseline case series design across two different service settings to evaluate if ADepT is feasible, acceptable, and effective
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged >18 years 2. Score in the clinical range on the PHQ-9 depression scale (scores =10) 3. Meet diagnostic criteria for a current major depressive episode using the Structured Clinical Interview for Diagnosis 4. Describe depression as the primary presenting problem they wish to work on 5. Report some difficulties in emotional, interpersonal, identity or impulsivity regulation, consistent with personality difficulties and/or mild personality disorder linked to exposure to complex trauma during childhood 6. Willing and able to give informed consent for participation in the trial 7. Have working knowledge of written and spoken English, sufficient to be able to make use of therapy and to be able complete research assessments without the need for a translator 8. Willing to allow their General Practitioner to be notified of participation in the trial
Exclusion criteria
Exclusion criteria: 1. Currently receiving other psychosocial therapies 2. Presenting with another area of difficulty that the therapist and/or client believe should be the primary focus of the current intervention (for example, PTSD, complex PTSD, eating disorder) 3. reporting a current/past history of schizophrenia or bipolar disorder 4. Presenting with current moderate to severe personality disorder that requires secondary or tertiary care management 5. Displaying marked risk to self (self-harm or suicide) or others that the clinician judges could not be managed safely using weekly therapy in an out-patient setting and that would interfere with engagement in therapy 6. Presenting with features of substance misuse, problematic eating, and/or antisocial that the clinician judges could not be managed safely using weekly therapy in an out-patient setting and that would interfere with engagement in therapy 7. Presenting with features of a learning disability that the clinician judges would interfere with engagement in therapy and capacity to complete research assessments 8. Currently lacking capacity to give informed consent 9. Presenting with any other significant, severe or life-threatening disease, disorder, or cognitive impairment that the clinician judges may either put the participants at risk because of participation in the trial, may influence the result of the trial, or inhibit the participant’s ability to participate in the trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Recruitment rate, recorded as the number of clients recruited at each site over a 6-month window 2. Treatment engagement, recorded as the number of clients who completed treatment with a planned discharge and as the number of clients attending at least 10 sessions (50% of acute treatment dose), measured at the end of the acute treatment phase 3. Satisfaction with treatment, recorded as the number of clients and therapists rating treatment as acceptable, satisfactory and that they would recommend it to others, measured at the end of the acute treatment phase 4. Patient safety, recorded as the number of serious incidents that could be clearly attributed to the intervention or research participation, measured over the duration of the trial 5. Preliminary signal of clinical efficacy, indexed as the number of clients showing at least reliable improvement and/or a positive change in slope/level in time series analysis of depression, anxiety and/or wellbeing (see list of secondary outcome measures below for details), measured at the end of the acute treatment phase | — |
Secondary
| Measure | Time frame |
|---|---|
| The following clinical outcome measures will be collected weekly during the baseline, treatment and 2-month post-treatment phase: 1. Depression symptoms measured using the Patient Health Questionnaire (PHQ-9) 2. Anxiety symptoms measured using the Generalized Anxiety Disorder Scale (GAD-7) 3. Wellbeing measured using the Warwick Edinburgh Mental Wellbeing Scale Short Form (WEMWBS-SF) The following clinical outcome measures will be collected at intake, pre-treatment, post-treatment, 2-month follow-up and 1-year follow-up extended assessment: 1. PHQ-9, GAD-7 as described above 2. Wellbeing measured using the Warwick Edinburgh Mental Wellbeing Scale full scale (WEMWBS-FS) 3. Personality disorder symptoms/features measured using the PDS-ICD-11 4. Anxiety symptoms measured using the Generalized Anxiety Disorder Scale (GAD-7) 5. Anhedonia symptoms measured using the Snaith Hamilton Pleasure Scale (SHAPS) 6. Life satisfaction measured using the DIALOG Scale 7. Quality of life measured using the Recovering Quality of Life Scale 10-item version (ReQoL-10) 8. Functioning measured using the Work and Social Adjustment Scale (WSAS) 9. The hypothesized mechanism of change in ADepT assessed using the ADepT Outcome Tool 10. At 1-year follow-up only a retrospective diagnostic interview will be used to assess if individuals met the criteria for a depressive episode over the past month All participants and therapists will be invited to take part in a qualitative interview after treatment is completed to explore their experiences of therapy | — |
Countries
England, United Kingdom
Outcome results
None listed