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Completed

NCT Number: NCT06133582

Mood Awareness Psychotherapy Support

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Primary outcomes

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

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

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

Secondary outcomes

  1. Generalised Anxiety Disorder Questionnaire (GAD-7)

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

    The GAD-7 features seven items for assessing anxiety and screening for generalized anxiety disorder. Scores range from 0-21, higher scores indicate more severe anxiety.

  2. Patient Health Questionnaire (PHQ-9)

    Time frame: 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).

    The PHQ-9 features nine items for assessing depression. Scores range from 0-27, higher scores indicate more severe depression.

  3. Defences Questionnaire DMRS-SR-30

    Time frame: 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).

    30-item self-rated measure of psychological defences

Other outcomes

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

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

    12-item self-rated measure of working alliance. Scores range from 12-60, higher scores indicate a stronger alliance.

  2. Depressive Experiences Questionnaire (DEQ English version)

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

    66-item self-report questionnaire designed to differentiate between dependency and self-criticism in people experiencing depression.

  3. Attitudes towards Psychological Online Interventions-the APOI

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

    16-item self-report questionnaire designed to measure participants' attitudes towards and expectations of psychological online interventions. Higher scores indicate a more positive attitude towards psychological online interventions.

  4. Relationship Styles Questionnaire

    Time frame: Baseline only.

    This is a self-report questionnaire designed to measure adult attachment style. Participants are presented with a short description of each attachment style (secure, fearful, preoccupied, dismissive). They first select which style best matches their own, and then rate each style on a likert scale from 1 - 7, where 1 is very unlike their relationship style, and 7 is very similar to their relationship style.

  5. The Post Study System Usability Questionnaire (PSSUQ) - with minorly adapted wording to suit the therapy platform

    Time frame: Participants complete this in week 10

    16-item self-report questionnaire measuring participants' experience of using the therapy platform. Lower scores indicate greater satisfaction with the usability of the platform.

  6. Interview

    Time frame: Participants complete this after week 10, before 3 month follow up.

    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'.

Sponsors and collaborators

Lead sponsor

University College, London

Other

Collaborators

  • Linkoeping University
  • Stockholm University

Registry information

Official study title

Mood Awareness Psychotherapy Support - A Randomised Feasibility Trial of an Internet-Based Psychodynamic Treatment for University Students With Low Mood

Acronym: MAPS

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Nov 15, 2023
Registry last updated
Oct 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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