Mood Awareness Psychotherapy Support

NCT06133582 | Completed

• 1 other identifier: 26049/001
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression, Anxiety

Outcome Measures

Primary Outcomes (1)

• Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)

  The 16-item QIDS-SR measures depressive symptoms. Scores range from 0-27, higher scores indicate more severe depression.

  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 (3)

• Generalised Anxiety Disorder Questionnaire (GAD-7)

  Change from baseline to post-treatment (10 week) and follow up at 3 months after treatment (participants complete the measure weekly throughout the intervention).

• Patient Health Questionnaire (PHQ-9)

  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).

• Defences Questionnaire DMRS-SR-30

  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 (6)

• The Working Alliance Inventory for guided Internet interventions (WAI-I)

  Participants complete this measure at weeks 2, 3, 4, 5, 6, 7, 8, 9, & 10.

• Depressive Experiences Questionnaire (DEQ English version)

  Participants complete this at baseline, week 10, and 3 month follow up.

• Attitudes towards Psychological Online Interventions-the APOI

  Participants complete this at baseline, week 10, and 3 month follow up.

Study Arms (1)

Internet-Based Psychodynamic Psychotherapy

EXPERIMENTAL

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

Behavioral: Internet Based Psychodynamic Psychotherapy

Interventions

Internet Based Psychodynamic Psychotherapy 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).

Internet-Based Psychodynamic Psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• score of 10 or more on the QIDS-SR

You may not qualify if:

• 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

Sponsors & Collaborators

• University College, London: lead
• Linkoeping University: collaborator
• Stockholm University: collaborator

Study Sites (1)

University College London

London, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 32224489 BACKGROUND

• 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.

  PMID: 35803894 BACKGROUND

• 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.

  PMID: 34948601 BACKGROUND

• 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.

  PMID: 40791020 DERIVED

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Rose Mortimer

  University College, London

  STUDY CHAIR

• Dominika Iluczyk

  University College, London

  STUDY CHAIR

• Jakob Mechler

  Stockholm University

  STUDY CHAIR

• Karin Lindqvist

  Stockholm University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 15, 2023
• Study Start: November 27, 2023
• Primary Completion: March 31, 2024
• Study Completion: August 1, 2024
• Last Updated: October 29, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)