NCT02748187

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable depression

Timeline
Completed

Started Jan 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 22, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

May 3, 2024

Status Verified

June 1, 2021

Enrollment Period

1.6 years

First QC Date

March 27, 2016

Last Update Submit

May 1, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    10 minutes

Study Arms (1)

Intervention

EXPERIMENTAL

Cognitive Behavioural Analysis System of Psychotherapy

Other: CBASP

Interventions

CBASPOTHER

Interpersonal psychotherapy for chronic depression

Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Current significant substance misuse
  • Undergoing other psychological treatment
  • Presence of learning disability or significant cognitive impairment
  • Presence of psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sarah Buckley

Edinburgh, Midlothian, United Kingdom

Location

Related Publications (1)

  • 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

    RESULT

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Sarah Buckley, BA, HDip, MA

    University of Edinburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2016

First Posted

April 22, 2016

Study Start

January 1, 2016

Primary Completion

August 1, 2017

Study Completion

August 1, 2017

Last Updated

May 3, 2024

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will share

via peer review journal

Locations