Prolonged grief disorder Mental and Behavioural Disorders
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Current key inclusion criteria as of 05/05/2026: 1. Aged 18 years and above 2. Willing and able to provide informed consent 3. Meets diagnostic criteria for PGD using the ICD-11 criteria and grief is the primary clinical concern 4. Able to read and write in English 5. Regular, private access to internet-enabled device and reliable internet connection 6. Have enough time in their week to be able to log in and work on the programme regularly (i.e. at least 20 mins on 3-4 days each week) 7. Willing to be randomly allocated to psychological treatment or waitlist 8. If on medication for mood/anxiety, the participant agrees not to change medication during the study. This is routine practice within TTAD services. For those patients who are already taking medication at the start of the psychological therapy, participants are asked not to change their medication while they are learning psychological skills for overcoming PGD in order to avoid complicating the clinical picture. Participants are required to have been on a stable dose of medication for at least 1 month before beginning treatment. 9. If currently receiving psychological therapy, this treatment must have ended before randomisation _____ Previous key inclusion criteria: 1. Aged 18 years and above 2. Willing and able to provide informed consent 3. Meets diagnostic criteria for PGD using the ICD-11 criteria 4. Able to read and write in English 5. Regular, private access to internet-enabled device and reliable internet connection 6. Have enough time in their week to be able to log in and work on the programme regularly (i.e. at least 20 mins on 3-4 days each week) 7. Willing to be randomly allocated to psychological treatment or waitlist 8. If on medication for mood/anxiety, the participant agrees not to change medication during the study. This is routine practice within TTAD services. For those patients who are already taking medication at the start of the psychological therapy, participants are asked not to change their medication while they are learning psychological skills for overcoming PGD in order to avoid complicating the clinical picture. 9. If currently receiving psychological therapy, this treatment must have ended before randomisation
Exclusion criteria
Exclusion criteria: Current key exclusion criteria as of 05/05/2026: 1. History of psychosis 2. Current dependence on alcohol or substances 3. Current psychosis/bipolar affective disorder/emotionally unstable personality disorder (NB. These conditions are not typically treated within TTAD services) 4. Marked clinical risk based on the service’s intake assessment or the eligibility assessment 5. Currently participating in another clinical research study 6. Experience of an additional significant bereavement in the last 6 months (NB. To avoid disruption of the natural recovery process) _____ Previous key exclusion criteria: 1. History of psychosis 2. Current dependence on alcohol or substances 3. Current psychosis/bipolar affective disorder/emotionally unstable personality disorder (NB. These conditions are not typically treated within TTAD services) 4. Marked clinical risk based on the service’s intake assessment or the eligibility assessment 5. Currently participating in another clinical research study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prolonged grief disorder symptoms measured with the International Prolonged Grief Disorder Scale (IPGDS) at baseline, 7, 15 weeks after random allocation (with follow-ups at 27, and 39), and weekly during treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Current key secondary outcome(s) as of 05/05/2026: 1. Assessor ratings of PGD symptoms, assessed with a structured clinical interview at 15 weeks after random allocation (with follow-up at 27 weeks). 2. Other symptom measures assessed at baseline, 7, 15 weeks after random allocation (with follow-ups at 27 and 39 weeks), and some weekly during treatment: 2.1. Depression, assessed with the Patient Health Questionnaire (PHQ-9) 2.2. Anxiety, assessed with the Generalized Anxiety Disorder Scale 7-items (GAD-7) 2.3 Posttraumatic stress disorder with the PTSD checklist for DSM 5 (PCL-5) 2.4. Disability, assessed with the Work and Social Adjustment Scale (WSAS) 2.5. Sleep problems, assessed with the Insomnia Sleep Index (ISI) 2.6 Well-being, assessed with the Warwick Edinburgh Mental Wellbeing Scale (WEMBWS) 2.7 Alcohol use and dependence assessed with the Alcohol Use Disorders Identification Test (AUDIT) 3. Health economics measures (Euroqol EQ-5D-5L12, iMTA Productivity Cost Questionnaire (PCQ), Recovering Quality of Life (ReQoL-10), Client Service Receipt Inventory (CSRI), employment status and state benefits), assessed at baseline, 15, 27 and 39 weeks 4. Process measures assessed at baseline, 7, 15, 27, and 39 weeks after random allocation (and some weekly during treatment): 4.1. Excessively negative appraisals, assessed with the Oxford Grief Appraisals Scale (OG-A) 4.2. Memory characteristics, assessed with the Oxford Grief Memory Scale (OG-M) 4.3. Unhelpful strategies to deal with grief, assessed with the Oxford Grief Coping Strategies scale (OG-CS) 4.4 Social disconnection, assessed with the Oxford Grief Social Disconnection Scale (OG-SD) 4.5. Safety behaviours, assessed with the short version Safety Behaviours Questionnaire (SBQ) 4.6. Dissociation, assessed with the short version State-Trait Dissociation Questionnaire (TSDQ) Other process measures: 1. Therapeutic alliance, assessed using the Working Alliance Inventory (WAI) at weeks 2 and 7 2. Patient satisfactio | — |
Countries
England, United Kingdom