Pilot randomised controlled trial of augmented depression therapy

Phase 2

Completed

• Conditions: Specialty: Mental Health, Primary sub-specialty: Depression; UKCRC code/ Disease: Mental Health/ Mood [affective] disorders; Mental and Behavioural Disorders; Depression

• Registration Number: ISRCTN85278228
• Lead Sponsor: niversity of Exeter

Brief Summary

2019 Protocol article in https://doi.org/10.1186/s40814-019-0438-1 (added 29/03/2021) 2023 Results article in https://doi.org/10.1016/j.eclinm.2023.102084 (added 17/07/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-27
• Study Completion: 2020-01-01
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

1. Aged over 18 or over
2. Suffering from a current major depressive episode (MDE) assessed by structured clinical interview for diagnosis (SCID-I)
3. Have a Patient Health Questionnaire (PHQ-9) depression score =>10
4. Present with significant anhedonic symptoms (PHQ-9 item 1 score =>2)

Exclusion Criteria

1. Depression is not the primary presenting problem
2. Alcohol or drug dependent
3. Acutely suicidal or self-harming
4. Cognitively impaired
5. Have bipolar disorder or psychosis/psychotic symptoms ascertained at baseline research interviews
6. Currently receiving another psychological therapy

Study & Design

• Study Type: Interventional
• Study Design: Not specified