Mood Awareness Psychotherapy Support

Study Overview
=================
Brief Summary
-----------------
The aim of this mixed-methods, two arm, randomised waitlist control feasibility trial is to examine an internet delivered, self-help program for depression and anxiety, based on psychodynamic therapy. The study will compare two conditions: the psychodynamic program with therapist support, and a waitlist control. 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, we do not know 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 mixed-methods, two arm, randomised waitlist control feasibility trial. We aim to recruit approximately 80 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 will be undertaken to explore moderators and mediators of change. Participants in the treatment arm 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.

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

Conditions
-----------------
Depression, Anxiety

Intervention / Treatment
-----------------
* Behavioral: Internet Based Psychodynamic Psychotherapy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Internet-Based Psychodynamic Psychotherapy<br>Participants received the internet-based intervention for 10 weeks, supported by messages from their Therapeutic Support Worker. | Behavioral: Internet Based Psychodynamic Psychotherapy<br>* 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).<br>|
| No Intervention: Waitlist Control<br>Participants will receive no intervention for 10 weeks | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Generalised Anxiety Disorder Questionnaire (GAD-7) | 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. | 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) | The PHQ-9 features nine items for assessing depression. 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 at baseline, week 5, week 10, and follow up at 3 months). | 
| Defences Questionnaire DMRS-SR-30 | 30-item self-rated measure of psychological defences | 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). |