Mood Awareness Psychotherapy Support

NCT ID: NCT06133582

Last Updated: 2024-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-27

Study Completion Date

2024-08-01

Brief Summary

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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

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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.

Conditions

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Depression, Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Internet-Based Psychodynamic Psychotherapy

Participants received the internet-based intervention for 10 weeks, supported by messages from their Therapeutic Support Worker.

Group Type EXPERIMENTAL

Internet Based Psychodynamic Psychotherapy

Intervention Type BEHAVIORAL

This is a 10-week intervention, delivered on a website called 'Iterapi' which was developed 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.

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 (Malan, 1995).

Interventions

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Internet Based Psychodynamic Psychotherapy

This is a 10-week intervention, delivered on a website called 'Iterapi' which was developed 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.

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 (Malan, 1995).

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Linkoeping University

OTHER_GOV

Sponsor Role collaborator

Stockholm University

OTHER

Sponsor Role collaborator

University College, London

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rose Mortimer

Role: STUDY_CHAIR

University College, London

Dominika Iluczyk

Role: STUDY_CHAIR

University College, London

Jakob Mechler

Role: STUDY_CHAIR

Stockholm University

Karin Lindqvist

Role: STUDY_CHAIR

Stockholm University

Locations

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University College London

London, , United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type BACKGROUND
PMID: 32224489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35803894 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34948601 (View on PubMed)

Mortimer R, Iluczyk D, Mechler J, Lindqvist K, Midgley N, Andersson G, Clements H. Experience of self-discovery and change in a psychodynamic internet delivered programme for university students experiencing low mood. Psychother Res. 2025 Aug 12:1-16. doi: 10.1080/10503307.2025.2538552. Online ahead of print.

Reference Type DERIVED
PMID: 40791020 (View on PubMed)

Other Identifiers

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26049/001

Identifier Type: -

Identifier Source: org_study_id

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