Effectiveness of CAT-GSH for Returning Patients
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16+
SponsorUniversity of Sheffield
About this trial
The goal of this clinical trial is to learn if cognitive analytic therapy-guided self-help (CAT-GSH) is comparable to cognitive behavioural therapy-guided self-help (CBT-GSH) in terms of whether it is effective and acceptable for people with anxiety or low mood, who are returning to NHS Talking Therapy services for further treatment. The main questions it aims to answer are:
* Does CAT-GSH work well and feel acceptable for people coming back to the Talking Therapies service, compared to CBT-GSH, when taking their characteristics (like age) into account * Does CAT-GSH work well and feel acceptable for people coming back to the Talking Therapies service, compared to those using CBT-GSH for the first time, when taking their characteristics (like age) into account?
Participants will:
* Choose their preferred treatment * Complete 6 sessions of either CAT-GSH or CBT-GSH * Sessions will be weekly or bi-weekly * Complete routine outcome measures before, during and at the end of therapy
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Previously received CBT-GSH at same participating NHS Talking Therapies service
Presenting with anxiety or depression
Deemed suitable for step 2 low-intensity therapy, through assessment by a qualified PWP
Disqualifiers
Previously received high-intensity therapy since receiving CBT-GSH
The previous treatment episode was in another NHS Talking Therapies service.
Not fluent in English
Trial design
Design model
Parallel
Treatments tested in this trial
Cognitive analytic therapy guided self-help (CAT-GSH)
BehavioralSix session CAT-GSH treatment
Cognitive behavioural therapy guided self-help (CBT-GSH)
BehavioralSix session CBT-GSH treatment
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: CBT-GSH armActive comparator 1 intervention
Group B: CAT-GSH armActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Composite score (Generalised Anxiety Disorder-7 (GAD-7), Patient health Questionaire-9 (PHQ-9) and Work and Social Adjustment Scale (WSAS))
Routine outcome measures, Generalised Anxiety Disorder-7 (GAD-7), Patient Health Questionaire-9 (PHQ-9) and Work and Social Adjustment Scale (WSAS) collected before, during and after treatment will be combined into composite scores.
Time frame
From enrolment to the end of treatment after 6 sessions, weekly or bi-weekly. 6-12 weeks.Secondary outcomes
1
Patient Health Questionnaire (PHQ-9)
Routine outcome measure, collected as part of normal treatment at the NHS Talking Therapy site - Patient Health Questionnaire-9 (PHQ-9). Collected before, during and after treatment. The PHQ-9 uses a 9-item scale with a total severity score of 0-27. Higher scores indicate greater depression and the clinical cut-off point indicating significant depression is ≥10.
Time frame
From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.2
Generalised Anxiety Disorder (GAD-7)
Routine outcome measure, collected as part of normal treatment at the NHS Talking Therapy site - Generalised Anxiety Disorder-7 (GAD-7). Collected before, during and after treatment. The GAD-7 uses a 7-item scale with a total severity score ranging from 0 to 21. Higher scores indicate greater anxiety and the clinical cut-off indicating significant anxiety is ≥8
Time frame
From enrolment to the end of treatment at 6-12 weeks. Sessions weekly or bi-weekly.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Sheffield
Lead sponsor
Catalyse CAT Limited
Collaborator
Tameside and Glossop Talking Therapies service
Collaborator
Leeds Mental Wellbeing service
Collaborator
Source ClinicalTrials.gov