Clinical trial NCT06133582: Mood Awareness Psychotherapy Support
Official title: Mood Awareness Psychotherapy Support - A Randomised Feasibility Trial of an Internet-Based Psychodynamic Treatment for University Students With Low Mood
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression, Anxiety
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Linkoeping University
name: Stockholm University
First posted: 2023-11-15
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Update January 2024: This trial has been transformed from a two arm randomised control trial to a single arm trial, due to challenges with recruitment. 51 participants have been successfully recruited and have now been invited to complete baseline measures. All participants will receive the intervention (the online therapy programme) once baseline data collection is complete.
Primary purpose: TREATMENT

Brief summary: The aim of this single arm feasibility trial is to examine an internet delivered, self-help program for depression and anxiety, based on psychodynamic therapy. The study will evaluate the psychodynamic program with therapist support. The participants will be university students.

Detailed description: Background: There appears to be an increase in mental health difficulties amongst higher education students in the UK. However, NHS services are over-stretched, and clients often experience long waits for treatment, during which time their symptoms may worsen. Internet-based therapies could be an important and accessible treatment option, particularly when provided within the context of the university, as this has the potential to provide timely treatment to those seeking help.

The majority of internet-based therapies use a Cognitive Behavioural Therapy framework. However, psychodynamic therapy has also been adapted to an internet-based format - often called 'iPDT'. One such iPDT programme was developed in Sweden for the treatment of adolescent depression. This is a self-guided programme, with therapist support. Clients 'chat' with their therapist once a week, for 30-minutes, using an instant-messaging platform on the therapy website. They can also send a-synchronous messages to their therapist, and the therapist can view the worksheets that client's complete on the therapy website.

This iPDT programme has been evaluated in two Randomised Controlled Trials, both of which showed it to be effective. Given the promising results of the Swedish iPDT programme, a research team at the Anna Freud Centre in the UK conducted a pilot study of an English-language version of the treatment; this pilot found evidence of a decrease in adolescents' symptoms of depression, and an improvement in emotion regulation, at the end of the 10-week treatment, with outcomes maintained at three month follow up.

At present, it is not known whether the iPDT programme would be accepted by, and effective for, participants without the weekly instant-messaging sessions. These 'chat sessions' are valued by many service users, but increase the cost and intensity of the programme. Furthermore, to date, the English-language version of the programme has not been tested with a university student population - young adults, rather than adolescents.

Study aims and design: This will be a single arm feasibility trial. The aim is to recruit approximately 50 university students with symptoms of depression and anxiety.

The aims of the study are to assess recruitment and retention rates of participants, including at three month follow up. To examine acceptability of the platform for the new target population, including levels of engagement with different elements of the treatment across the course of the intervention. The study will also explore indications of treatment efficacy. Additional exploratory analyses may be undertaken to explore moderators and mediators of change.

Participants will receive Internet Based Psychotherapy (iPDT). This is a 10-week intervention, delivered on the therapy website - called 'Iterapi' - which was developed at Linköping University in Sweden. The programme involves creative and interactive web-based content: worksheets, audio, video, expressive writing exercises. Additionally, each participant is assigned a Therapeutic Support Worker (TSW). The TSW logs into the platform and views the questionnaires and other data provided by the participants that they are supporting. Each week, the TSW sends each of their participants a reflective message in response to the data they have provided when interacting with the programme over the last week. The participant can reply to this message.

After completing the 10 week intervention, qualitative data will be collected via interviews with some participants to explore participants' experiences of the IPDT programme, in particular focussing on therapy process and their understandings of mechanisms of change, and of 'what works for whom'. Participants will also complete a set of follow up questionnaires 3 months after they complete the intervention.

The iPDT programme has 8 chapters. The principal objective of the iPDT intervention is to reduce depressive symptoms through the promotion of emotional awareness and emotional experience. The intervention is an affect-focused therapy and draws on Malan's Triangle of Conflict. Participants are invited to link their emotions to depressive symptoms, to challenge defences, regulate anxiety, and explore previously avoided feelings.

Eligibility criteria: Inclusion Criteria:

* score of 10 or more on the QIDS-SR

Exclusion Criteria:

* Under 18 years of age
* Not a current student at University College London (UCL)
* Previous diagnosis of: Bipolar disorder, any personality disorder, Psychosis / Schizophrenia, Post Traumatic Stress Disorder, intellectual disability
* Not being able to confidently read or write in English
* No access to a device which can access the internet
* Previous suicide attempts
* Current plans to attempt suicide
* Currently receiving psychological therapy
* Planning to begin psychological therapy during the duration of the intervention
* Starting new medication for mood, or using mood-medication inconsistently, over the last 3 months

Primary outcomes:
measure: Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)
timeFrame: Change from baseline to post-treatment (10 week) and follow up at 3 months after treatment (participants complete the measure weekly throughout the intervention)
Secondary outcomes:
measure: Generalised Anxiety Disorder Questionnaire (GAD-7)
timeFrame: Change from baseline to post-treatment (10 week) and follow up at 3 months after treatment (participants complete the measure weekly throughout the intervention).
measure: Patient Health Questionnaire (PHQ-9)
timeFrame: Change from baseline to post-treatment (10 week) and follow up at 3 months after treatment. (Participants complete the measure at baseline, week 5, week 10, and follow up at 3 months).
measure: Defences Questionnaire DMRS-SR-30
timeFrame: Change from baseline to post-treatment (10 week) and follow up at 3 months after treatment. (Participants complete the measure at baseline, week 5, week 10, and follow up at 3 months).
Other outcomes:
measure: The Working Alliance Inventory for guided Internet interventions (WAI-I)
timeFrame: Participants complete this measure at weeks 2, 3, 4, 5, 6, 7, 8, 9, & 10.
measure: Depressive Experiences Questionnaire (DEQ English version)
timeFrame: Participants complete this at baseline, week 10, and 3 month follow up.
measure: Attitudes towards Psychological Online Interventions-the APOI
timeFrame: Participants complete this at baseline, week 10, and 3 month follow up.
measure: Relationship Styles Questionnaire
timeFrame: Baseline only.
measure: The Post Study System Usability Questionnaire (PSSUQ) - with minorly adapted wording to suit the therapy platform
timeFrame: Participants complete this in week 10
measure: Interview
timeFrame: Participants complete this after week 10, before 3 month follow up.
Locations:
city: London
country: United Kingdom
facility: University College London
Study officials:
affiliation: University College, London
name: Rose Mortimer
role: STUDY_CHAIR
affiliation: University College, London
name: Dominika Iluczyk
role: STUDY_CHAIR
affiliation: Stockholm University
name: Jakob Mechler
role: STUDY_CHAIR
affiliation: Stockholm University
name: Karin Lindqvist
role: STUDY_CHAIR
References:
citation: Lindqvist K, Mechler J, Carlbring P, Lilliengren P, Falkenstrom F, Andersson G, Johansson R, Edbrooke-Childs J, Dahl HJ, Lindert Bergsten K, Midgley N, Sandell R, Thoren A, Topooco N, Ulberg R, Philips B. Affect-Focused Psychodynamic Internet-Based Therapy for Adolescent Depression: Randomized Controlled Trial. J Med Internet Res. 2020 Mar 30;22(3):e18047. doi: 10.2196/18047.
citation: Mechler J, Lindqvist K, Carlbring P, Topooco N, Falkenstrom F, Lilliengren P, Andersson G, Johansson R, Midgley N, Edbrooke-Childs J, Dahl HJ, Sandell R, Thoren A, Ulberg R, Bergsten KL, Philips B. Therapist-guided internet-based psychodynamic therapy versus cognitive behavioural therapy for adolescent depression in Sweden: a randomised, clinical, non-inferiority trial. Lancet Digit Health. 2022 Aug;4(8):e594-e603. doi: 10.1016/S2589-7500(22)00095-4. Epub 2022 Jul 5.
citation: Midgley N, Guerrero-Tates B, Mortimer R, Edbrooke-Childs J, Mechler J, Lindqvist K, Hajkowski S, Leibovich L, Martin P, Andersson G, Vlaescu G, Lilliengren P, Kitson A, Butler-Wheelhouse P, Philips B. The Depression: Online Therapy Study (D:OTS)-A Pilot Study of an Internet-Based Psychodynamic Treatment for Adolescents with Low Mood in the UK, in the Context of the COVID-19 Pandemic. Int J Environ Res Public Health. 2021 Dec 9;18(24):12993. doi: 10.3390/ijerph182412993.