Mood Awareness Psychotherapy Support

Depression, Anxiety Clinical Trial

— MAPS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06133582
• Other study ID #: 26049/001
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 27, 2023
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2024
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 singel arm feasibility trial. We aim 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 51
• Est. completion date: September 1, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depression, Anxiety

Intervention

Behavioral:
• 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).

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (3)

Lead Sponsor	Collaborator
University College, London	Linköping University, Sweden, Stockholm University

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The Working Alliance Inventory for guided Internet interventions (WAI-I)	12-item self-rated measure of working alliance. Scores range from 12-60, higher scores indicate a stronger alliance.	Participants complete this measure at weeks 2, 3, 4, 5, 6, 7, 8, 9, & 10.
Other	Depressive Experiences Questionnaire (DEQ English version)	66-item self-report questionnaire designed to differentiate between dependency and self-criticism in people experiencing depression.	Participants complete this at baseline, week 10, and 3 month follow up.
Other	Attitudes towards Psychological Online Interventions-the APOI	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.	Participants complete this at baseline, week 10, and 3 month follow up.
Other	Relationship Styles Questionnaire	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.	Baseline only.
Other	The Post Study System Usability Questionnaire (PSSUQ) - with minorly adapted wording to suit the therapy platform	16-item self-report questionnaire measuring participants' experience of using the therapy platform. Lower scores indicate greater satisfaction with the usability of the platform.	Participants complete this in week 10
Other	Interview	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 complete this after week 10, before 3 month follow up.
Primary	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	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).
Secondary	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).
Secondary	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).