Depression Mental and Behavioural Disorders
Conditions
Interventions
ADepT+ therapy consists of up to 20 acute 60-minute individual therapy sessions over 8 months, followed by up to 5 optional 60-minute booster sessions offered flexibly in the subsequent 12 months. Th
Sponsors
University of Exeter
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or older 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 prefer therapy to focus on 5. Report difficulties in emotional, interpersonal, identity or impulsivity regulation, consistent with personality difficulties or personality disorder (assessed by scoring >=9 on the PDS-ICD-11 ) 6. Willing and able to give informed consent for participation within the trial 7. Have sufficient written and spoken English to be able to make use of therapy and to be able to complete research assessments without the need of a translator 8. Have completed the intake measures 9. Be registered with a General Practice within the study site catchment area (Devon) who they are willing to be notified of their participation within the trial Therapist participant inclusion: 1. Served as a therapist on the ADepT+ feasibility trial 2. Delivered at least one ADepT+ therapy session to a participant
Exclusion criteria
Exclusion criteria: 1. Currently receiving psychosocial therapy 2. Current substance dependence according to ICD-11 criteria (as this may interfere with the ability to engage in and use therapy; current substance abuse is not an exclusion criterion) 3. Current/past history of schizophrenia or Bipolar-I diagnosis (Bipolar-II diagnosis not an exclusion criterion) 4. Presents with co-occurring difficulties that cannot be safely managed in a primary care outpatient setting; or that would significantly interfere with engagement in therapy; or are indicated to be the most appropriate primary focus of current treatment (for example, PTSD, complex PTSD, problematic eating, cognitive impairment, learning disability) 5. Current moderate to severe personality disorder and/or antisocial personality traits that require secondary/tertiary care management 6. Displaying marked risk to self (self-harm or suicide) or others, that cannot be safely managed in a primary care outpatient setting 7. Participant anticipates they will be unable to regularly attend therapy sessions within the site area (e.g. planning to move out of the study area, work commitments prevent regular attendance, lengthy period of travel not mitigated by access to online therapy sessions) 8. Currently receiving inpatient mental healthcare No specific therapist participant exclusion criteria.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcomes of this study relate to the primary feasibility and acceptability aims (recruitment rate, data availability, proportion of participants receiving minimum adequate dose of therapy, therapy acceptability ratings, safety of trial and intervention procedures). However, the candidate primary outcome for a future fully powered trial is: Recovering Quality of Life tool (ReQoL-10; 25) - a 10-item self-report measure of recovery of quality of life for people with mental health difficulties, measured at baseline, 8, 14 and 20 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at baseline, 8, 14 and 20 months: 1. Patient Health Questionnaire (PHQ-9) – a 9-item self-report measure of depression symptom severity over the past week, to assess for the presence of current depression, also measured at each therapy session for the intervention group 2. Self-report PDS-ICD-11 – an 11-item self-report scale that assesses for difficulties in emotional, relationship, identity and behavioural regulation consistent with the presence of a personality disorder, to assess for the presence of difficulties in emotional and interpersonal regulation 3. The International trauma questionnaire (ITQ) – an 18-item self-report scale assessing for the presence of current PTSD or complex PTSD, to assess for current PTSD and to determine if the client may be better suited by a current PTSD treatment) 4. Warwick-Edinburgh Mental Wellbeing Scale short form (WEMWBS-SF) – a 7-item self-report measure of positive wellbeing experiences over the past week, validated for use in adolescents and adults, also measured at each therapy session for the intervention group 5. Generalized Anxiety Disorder scale (GAD-7) – a 7-item self-report measure of anxiety symptom severity (given depression is frequently comorbid with anxiety), also measured at each therapy session for the intervention group 6. Snaith Hamilton Pleasure Scale (SHAPS) – a 14-item self-report measure of anhedonia severity 7. Work and Social Adjustment Scale (WSAS) – a 5-item self-report measure of psychosocial impairment as a result of poor mental health 8. DIALOG scale – an 11-item self-report measure of satisfaction in key life domains Interview/ clinician: 1. The Structured Clinical Interview for DSM-V (SCID-I) will be used to assess whether participants currently meet criteria for a Current Major Depressive Episode (and to rule out past episodes at intake) 2. Retrospective diagnostic interview to assess if they had met criteria for a major depressive episode in the period of time since completing acut | — |
Countries
England, United Kingdom
Contacts
Public ContactLaura Warbrick
Outcome results
None listed