Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT02470988 |
| Other study ID # |
15/WS/0027 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 2015 |
| Est. completion date |
December 2016 |
Study information
| Verified date |
June 2021 |
| Source |
University of Edinburgh |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The purpose of the study is to investigate the process of symptom change in Cognitive
Behavioural Analysis System of Psychotherapy (CBASP), and how the individual components of
the therapy affect this change in individuals with chronic depression.
Description:
A form of psychotherapy called Behaviour Analysis System of Psychotherapy (CBASP) has been
developed specifically to treat individuals suffering from chronic, long-standing depression.
There is a growing evidence base to suggest that CBASP is effective for these individuals,
especially when combined with anti-depressant medication. This evidence comes from case
series and randomised controlled trials that have compared CBASP with other forms of therapy
such as Interpersonal Psychotherapy and Cognitive Behaviour Therapy, and with medication. The
evidence from these studies consistently shows CBASP to be effective, and it compares
favourably with other forms of therapy.
Given these findings, it is important to understand how change happens in CBASP and how it is
affected by the components of the therapy. Understanding how individuals experience change
within CBASP will have important implications for how the therapy is delivered in the future.
For example if change is found to be non-linear it would be important to understand what
components of the therapy are associated with improvement. There could also be organisational
implications, for example relating to the optimal number of sessions to offer in order to
achieve acceptable change while balancing therapist time.
The proposed study aims to investigate the process of psychological change in CBASP. This
will be done by providing CBASP to a small number of individuals and gathering outcome data
(rating of mood) at every therapy appointment. Session--by-session change will then be mapped
for each participant. The study will include two arms: CBASP; and CBASP without Disciplined
Personal Involvement (DPI). DPI involves specifically using the therapist--client
relationship to help the client to discriminate between previous maladaptive relationships
and other, positive ones. The reason for including this condition is to investigate whether
DPI affects the process of psychological change in CBASP, as it is a unique feature of the
therapy.
The study will use a single-case design, as the aim is to map change within each individual
participant in the context of the therapy. This design was deemed appropriate as the study
does not aim to make claims about the overall effectiveness of CBASP, but to provide an
analysis of individual psychological change for participants receiving CBASP.
