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Trial registered on ANZCTR


Registration number
ACTRN12624000752561
Ethics application status
Approved
Date submitted
7/04/2024
Date registered
17/06/2024
Date last updated
17/06/2024
Date data sharing statement initially provided
17/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Group Schema Therapy for Co-occuring Anxiety and Depression
Scientific title
Feasibility of Group Schema Therapy for Co-occuring Anxiety and Depressive disorders in Adults
Secondary ID [1] 311487 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety 332814 0
Depression 332815 0
Condition category
Condition code
Mental Health 329528 329528 0 0
Anxiety
Mental Health 329529 329529 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
Group Schema Therapy is an established evidence-based protocol by Farrell & Shaw (2012) incorporating cognitive, behavioral and experiential techniques that focus on both group processes and tasks, whilst simultaneously being both efficient in use of resources. Consistent with published protocols (Straarup et al., 2022; Farrell & Shaw, 2014; Farrell, Shaw & Webber, 2009), concepts covered in the adapted group schema therapy program will include introduction to schema and modes, case formulation, and interventions for coping styles, modes and symptoms (education sessions, imagery work, chair work, cognitive and experiential exercises).
Procedure:
After initial contact is made, participants will be sent information statement and consent forms, and given the opportunity to discuss and ask questions before providing informed consent. Consent will be provided via the the secure web platform REDcap. Participants will be screened against the eligibility criteria using the Diagnostic Interview for Anxiety, Mood and OCD and Related Neuropsychiatric Disorders Screener (DIAMOND; Tolin et al., 2016), over the phone or in person or via videoconferencing software (Zoom). If they do not meet criteria, referral options and recommendations will be provided to them.
They will then be invited to come in for a short pre-treatment session (60-90 minutes).
Pre-treatment session: Interview to obtain mental health history, treatment goals, setting up group therapy expectations.
Following which, participants will participate in the 18 week group schema therapy program and complete routine outcome measures. Adherence will be monitored by attendance. Upon completion of the program, participants will be invited to participate in an interview to elicit feedback about the program.
Intervention Delivery:
Duration: 120 to 150 minutes for 18 weeks.
Group size: Group upto 11 participants.
Intervention will be delivered weekly for 18 sessions by licensed clinical psychologists and/or clinical psychology registrars registered by Australian Health Practitioner Regulation Agency.
Mode: Group therapy; Delivered in person at an approved site of The University of Sydney, Australia.
Post-treatment interview:
Participants would be invited to participate in an interview (60-90 minutes) post participation in the program. Semi-structured interview would be used to understand participant experiences and feasibility of the program. Interviews would be conducted by members of the research team and will be audio-recorded to aid in transcription and data analysis.
Intervention code [1] 327938 0
Treatment: Other
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337921 0
Feasibility and acceptability of intervention. This is a composite outcome.
Timepoint [1] 337921 0
End of 18-week treatment program.
Primary outcome [2] 338410 0
Attendance percentage (adherence)
Timepoint [2] 338410 0
End of 18-week treatment program.
Primary outcome [3] 338554 0
Feasibility analysis of patient experiences.
Timepoint [3] 338554 0
End of 18-week-treatment program.
Secondary outcome [1] 433707 0
Changes in Depression scores.
Timepoint [1] 433707 0
Weekly during the 18-week treatment program.
Secondary outcome [2] 433708 0
Changes in Schema.
Timepoint [2] 433708 0
Baseline and end of 18-week treatment program.
Secondary outcome [3] 433709 0
Changes in Self-compassion scores.
Timepoint [3] 433709 0
Baseline and end of 18-week treatment program.
Secondary outcome [4] 433710 0
Changes in Work and Social Adjustment. This will be assessed as a composite outcome.
Timepoint [4] 433710 0
Baseline, weekly, end of 18-week treatment program.
Secondary outcome [5] 433711 0
Changes in Health related Quality of Life scores.
Timepoint [5] 433711 0
Baseline, end of 18-week treatment program.
Secondary outcome [6] 433712 0
Changes in clinical outcomes. Clinical outcomes measured are subjective well-being deficits, problems/symptoms, life functioning difficulties and risk/harm. This will be assessed as a composite outcome.
Timepoint [6] 433712 0
Weekly during the 18-week treatment program.
Secondary outcome [7] 433713 0
Changes in symptom profile. Nine symptom dimensions covered include Somatization, Obsession-Compulsion, Interpersonal Sensitivity, Depression, Anxiety, Hostility, Phobic Anxiety, Paranoid ideation and Psychoticism. This will be assessed as a composite outcome using global indices.
Timepoint [7] 433713 0
Baseline, mid-treatment (after completion of 9th session) and end of 18-week treatment program.
Secondary outcome [8] 433714 0
Changes in Closeness in Relationship Experience
Timepoint [8] 433714 0
Baseline, mid-treatment (after completion of 9th session) and end of 18-week treatment program.
Secondary outcome [9] 433715 0
Changes in Schema modes.
Timepoint [9] 433715 0
Baseline and end of 18-week treatment program.
Secondary outcome [10] 433716 0
Changes in Group cohesion scores.
Timepoint [10] 433716 0
Weekly during the 18-week treatment program.
Secondary outcome [11] 433718 0
Changes in Shame scores.
Timepoint [11] 433718 0
Baseline and end of 18-week treatment program.
Secondary outcome [12] 433719 0
Changes in Working Alliance
Timepoint [12] 433719 0
Weekly during the 18-week treatment program.
Secondary outcome [13] 433720 0
Changes in symptom profile for Anxiety.
Timepoint [13] 433720 0
Baseline and end of 18-week treatment program.
Secondary outcome [14] 433721 0
Analysis of patient experiences
Timepoint [14] 433721 0
End of 18-week treatment program.
Secondary outcome [15] 435813 0
Changes in anxiety scores.
Timepoint [15] 435813 0
Weekly during the 18-week treatment program.
Secondary outcome [16] 435814 0
Changes in stress scores.
Timepoint [16] 435814 0
Weekly during the 18-week treatment program.
Secondary outcome [17] 435817 0
Changes in symptom profile for Mood.
Timepoint [17] 435817 0
Baseline and end of 18-week treatment program.

Eligibility
Key inclusion criteria
Adults 18 years and over, Diagnosis of an anxiety disorder and depressive disorder, Ability to consent, Can be involved in pharmacological therapy to manage symptoms (however, this is stable) but no concurrent psychotherapy.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals below 18 years, Diagnosis of either anxiety OR depressive disorder (only co-occurring diagnosis included), Involved in other concurrent psychological therapy, Presence of psychotic symptom, Severe suicidal ideation

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2024
Actual
Date of last participant enrolment
Anticipated
30/06/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 315774 0
University
Name [1] 315774 0
The University of Sydney
Country [1] 315774 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Country
Australia
Secondary sponsor category [1] 318438 0
None
Name [1] 318438 0
Address [1] 318438 0
Country [1] 318438 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314634 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 314634 0
https://www.sydney.edu.au/research/research-integrity-and-ethics.html
Ethics committee country [1] 314634 0
Australia
Date submitted for ethics approval [1] 314634 0
10/10/2023
Approval date [1] 314634 0
27/02/2024
Ethics approval number [1] 314634 0
2023/801

Summary
Brief summary
The proposed study will aim to address existing gaps in literature by conducting a feasibility study of a group schema therapy intervention for comorbid anxiety and mood disorders in adults. This will involve conducting an empirical investigation of a manualised group schema therapy intervention to understand feasibility and assess effectiveness of the group. The manualised group intervention will be based on the group protocol established by Farrell, Reiss & Shaw (2014) and further adopted by Younan, Farrell, & May (2017).

The group treatment will be conducted in an outpatient clinic by involving two co-therapists and ten patients per treatment group. Participants will complete quantitative measures of symptoms at pre, mid and post-test intervals to investigate preliminary feasibility of the program and qualitative analyses will be conducted to analyse patient experiences.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 132230 0
A/Prof Maree Abbott
Address 132230 0
The University of Sydney, Faculty of Science, Clinical Psychology Unit, School of Psychology, 94 Mallet St, Camperdown 2050 New South Wales
Country 132230 0
Australia
Phone 132230 0
+61 2 91144342
Fax 132230 0
Email 132230 0
maree.abbott@sydney.edu.au
Contact person for public queries
Name 132231 0
Maree Abbott
Address 132231 0
The University of Sydney, Faculty of Science, Clinical Psychology Unit, School of Psychology, 94 Mallet St, Camperdown 2050 New South Wales
Country 132231 0
Australia
Phone 132231 0
+61 2 91144342
Fax 132231 0
Email 132231 0
maree.abbott@sydney.edu.au
Contact person for scientific queries
Name 132232 0
Karishma Rajan Menon
Address 132232 0
University of Sydney, Faculty of Science, Clinical Psychology Unit, School of Psychology, 94 Mallet St, Camperdown 2050 New South Wales
Country 132232 0
Australia
Phone 132232 0
+61 2 91144343
Fax 132232 0
Email 132232 0
karishma.rajanmenon@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.