DepressionNCT02748187
Attachment Style and Reflective Functioning in CBASP
A study testing CBASP in people with Depression, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
Cognitive behavioural analysis system of psychotherapy (CBASP) is one of the only psychological models and treatments that has been designed specifically for patients diagnosed with chronic depression. CBASP in combination with antidepressants has been found to be the most effective treatment for chronic depression. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression
- What is being tested?
- CBASP
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2016to Aug 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Clients will be included in this study if they meet the following criteria:
- Meet Diagnostic Statistical Manual-5 (DSM-5) criteria for persistent depressive disorder
- Have the capacity to provide informed consent
- Are aged 18 - 64 inclusive
- Speak fluent English
- Do not meet any of the exclusion criteria
Show all 9Show fewer
- Therapists will be included in the study if they meet the following criteria:
- Have received training in CBASP
- Have a qualification in at least one psychological therapy
Who cannot join
- Clients will be excluded from the study if they do not meet inclusion criteria, as well as fulfilling any of the following criteria:
- Current significant substance misuse
- Undergoing other psychological treatment
- Presence of learning disability or significant cognitive impairment
- Presence of psychosis
- Therapists will be excluded from the study if they do not meet the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Are Therapist and Client Attachment Style and Reflective Functioning Associated With Outcomes in Cognitive Behavioural Analysis System of Psychotherapy (CBASP): A Longitudinal Proof of Concept Study
Cognitive behavioural analysis system of psychotherapy (CBASP) is one of the only psychological models and treatments that has been designed specifically for patients diagnosed with chronic depression. CBASP in combination with antidepressants has been found to be the most effective treatment for chronic depression. Despite an increasing amount of research into this intervention, researchers are less aware of the role that specific and common ingredients are accounted for in outcomes. Given that CBASP is a treatment model endorsed by the National Health Service Scotland (NHS Scotland), gaining a deeper knowledge and understanding about the active ingredients involved in their success ensures current practice is embedded in an evidence base. Conducting this research adds to the gap in the literature and identifies areas in which further exploration is warranted. Given the emphasis on therapist variables in relation to treatment outcomes, the results of this research will have wider implications from a service resource perspective. Training may be altered or needs emphasised in line with the results of the study to ensure most efficacious outcomes.
Limited research has looked at therapist and client variables that may contribute to therapeutic alliance/engagement, and clinical outcomes. The current study proposes to explore two variables that are hypothesized to contribute to outcomes based on the theoretical framework CBASP is grounded on, namely therapist and client attachment style and reflective functioning. This will be done by providing CBASP to a small number of participants and gathering outcome data from therapists and clients at each therapy appointment. Participants will also complete the Adult Attachment Interview (AAI), a semi structured interview which can also be coded for reflective functioning. This is a proof of concept case series design that aims to provide an analysis of individual psychological change in relation to the above variables of interest.
Read the detailed description
CBASP will consist of treatment of usual (i.e. one one-hour individual sessions on a weekly basis for up to 20 weeks) with additional outcome measures to be completed at each session. Therapists will receive a research pack which will outline when, and what, measures to administer and complete. To ensure anonymity and confidentiality of data collected, participants will be given identification numbers before data is submitted to a spread sheet for analysis.
9 CBASP therapists have been identified as suitable for participation in this study. Therapists will have the option to choose whether to take part in the research. Similarly, clients will be given the choice to take part in the research. To ensure at least one set of outcomes are achieved it is an aim of the study to provide the therapist with a minimum caseload of 2.
- Conditions
- Depression
- Being tested
- CBASP
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBASPOther
Interpersonal psychotherapy for chronic depression
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Cognitive Behavioural Analysis System of Psychotherapy Receives: Other: CBASP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychological distress on the Clinical Outcome in Routine Evaluation Measure (CORE)
The CORE questionnaire, administered to clients, required 10 questions in relation to current mood to be answered. A total score is provided by adding up items. This is a routine outcome measure used in CBASP.
Measured: 5 minutes
Depressive symptomology on the Patient Health Questionnaire (PHQ-9)
The PHQ-9 is a screening tool and monitor for depression that will be administered to clients. A total score is provided by adding up items.
Measured: 5 minutes
Therapeutic relationship on the Working Alliance Inventory (WAI)
The WAI is a questionnaire that assesses the quality of the therapeutic relationship. There are two versions, namely client and therapist versions. Both therapists and clients will complete this questionnaire. A total score is provided by adding up items.
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sarah Buckley, BA, HDip, MA, Principal investigator, University of Edinburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02748187
- Sponsor's protocol ID
- 15/SS/0232
- Status last verified
- Jun 2021
- First submitted
- 27 Mar 2016
- Last updated
- 3 May 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: via peer review journal
Publications
Buckley; Attachment Style and Depression: An Investigation into Interpersonal Factors and Processes; DClinPsychol dissertation, available from https://era.ed.ac.uk/bitstream/handle/1842/25759/Buckley2017.pdf?sequence=1&isAllowed=y
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Are Therapist and Client Attachment Style and Reflective Functioning Associated With Outcomes in Cognitive Behavioural Analysis System of Psychotherapy (CBASP): A Longitudinal Proof of Concept Study
- ClinicalTrials.gov ID
- NCT02748187
- Acronym / sponsor ID
- 15/SS/0232
- Conditions
- Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Aug 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 22 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cognitive behavioural analysis system of psychotherapy (CBASP) is one of the only psychological models and treatments that has been designed specifically for patients diagnosed with chronic depression. CBASP in combination with antidepressants has been found to be the most effective treatment for chronic depression. Despite an increasing amount of research into this intervention, researchers are less aware of the role that specific and common ingredients are accounted for in outcomes. Given that CBASP is a treatment model endorsed by the National Health Service Scotland (NHS Scotland), gaining a deeper knowledge and understanding about the active ingredients involved in their success ensures current practice is embedded in an evidence base. Conducting this research adds to the gap in the literature and identifies areas in which further exploration is warranted. Given the emphasis on therapist variables in relation to treatment outcomes, the results of this research will have wider implications from a service resource perspective. Training may be altered or needs emphasised in line with the results of the study to ensure most efficacious outcomes.
Limited research has looked at therapist and client variables that may contribute to therapeutic alliance/engagement, and clinical outcomes. The current study proposes to explore two variables that are hypothesized to contribute to outcomes based on the theoretical framework CBASP is grounded on, namely therapist and client attachment style and reflective functioning. This will be done by providing CBASP to a small number of participants and gathering outcome data from therapists and clients at each therapy appointment. Participants will also complete the Adult Attachment Interview (AAI), a semi structured interview which can also be coded for reflective functioning. This is a proof of concept case series design that aims to provide an analysis of individual psychological change in relation to the above variables of interest.
Detailed description
CBASP will consist of treatment of usual (i.e. one one-hour individual sessions on a weekly basis for up to 20 weeks) with additional outcome measures to be completed at each session. Therapists will receive a research pack which will outline when, and what, measures to administer and complete. To ensure anonymity and confidentiality of data collected, participants will be given identification numbers before data is submitted to a spread sheet for analysis.
9 CBASP therapists have been identified as suitable for participation in this study. Therapists will have the option to choose whether to take part in the research. Similarly, clients will be given the choice to take part in the research. To ensure at least one set of outcomes are achieved it is an aim of the study to provide the therapist with a minimum caseload of 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: CBASPCognitive Behavioural Analysis System of Psychotherapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Meet Diagnostic Statistical Manual-5 (DSM-5) criteria for persistent depressive disorder
- Have the capacity to provide informed consent
- Are aged 18 - 64 inclusive
- Speak fluent English
- Do not meet any of the exclusion criteria
Key exclusion criteria (6 listed)
- Clients will be excluded from the study if they do not meet inclusion criteria, as well as fulfilling any of the following criteria:
- Current significant substance misuse
- Undergoing other psychological treatment
- Presence of learning disability or significant cognitive impairment
- Presence of psychosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBASPInterpersonal psychotherapy for chronic depression | Other | Intervention |
Primary outcome
Psychological distress on the Clinical Outcome in Routine Evaluation Measure (CORE)
Time frame: 5 minutes
The CORE questionnaire, administered to clients, required 10 questions in relation to current mood to be answered. A total score is provided by adding up items. This is a routine outcome measure used in CBASP.
Depressive symptomology on the Patient Health Questionnaire (PHQ-9)
Time frame: 5 minutes
The PHQ-9 is a screening tool and monitor for depression that will be administered to clients. A total score is provided by adding up items.
Therapeutic relationship on the Working Alliance Inventory (WAI)
Time frame: 10 minutes
The WAI is a questionnaire that assesses the quality of the therapeutic relationship. There are two versions, namely client and therapist versions. Both therapists and clients will complete this questionnaire. A total score is provided by adding up items.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2024.
- Results publicationBuckley; Attachment Style and Depression: An Investigation into Interpersonal Factors and Processes; DClinPsychol dissertation, available from https://era.ed.ac.uk/bitstream/handle/1842/25759/Buckley2017.pdf?sequence=1&isAllowed=y
- Individual participant dataSharing planned: Yes. via peer review journal
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah Buckley, BA, HDip, MA principal investigator
University of Edinburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBASP in people with Depression, run by University of Edinburgh at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Psychological distress on the Clinical Outcome in Routine Evaluation Measure (CORE) (time frame: 5 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02748187, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2024.