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Does Disciplined Personal Involvement Precede Change in CBASP?

Primary Purpose

Chronic Depression

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Cognitive Behavioural Analysis System of Psychotherapy
CBASP Without DPI
Sponsored by
University of Edinburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Depression

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged between 18 and 64 years, inclusive
  • Have been depressed for 2 years or longer
  • Have had previous episodes of depression
  • Previous treatment (medication, psychotherapy or both) unsuccessful or participant has relapsed
  • Do not meet any of the exclusion criteria
  • Able to provide informed consent to participate in the study

Exclusion Criteria:

  • Received psychological therapy in previous 12 months
  • Current significant substance misuse
  • Presence of learning difficulties
  • Presence of psychosis
  • Unable to commit to the full duration of the study

Sites / Locations

  • NHS Tayside
  • NHS Lothian

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

CBASP

CBASP Without DPI

Arm Description

Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is a form of therapy specifically designed to treat individuals with chronic depression. CBASP combines a number of elements, with a focus on teaching the client to become aware of their interpersonal behaviour and its consequences.

In this arm CBASP will be delivered without Disciplined Personal Involvement (DPI) by the therapist.

Outcomes

Primary Outcome Measures

Patient Health Questionnaire - 9 (PHQ-9)
Administered at three weekly baseline assessments and then at every therapy session for all participants over a period of 6 months or up to 20 sessions.

Secondary Outcome Measures

Full Information

First Posted
June 10, 2015
Last Updated
June 22, 2021
Sponsor
University of Edinburgh
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1. Study Identification

Unique Protocol Identification Number
NCT02470988
Brief Title
Does Disciplined Personal Involvement Precede Change in CBASP?
Official Title
How is Psychological Change Experienced by Individuals Receiving Cognitive Behaviour Analysis System of Psychotherapy (CBASP) and How is This Affected by Disciplined Personal Involvement? A Multiple Baseline Single Case Design
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Edinburgh

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBASP
Arm Type
Active Comparator
Arm Description
Cognitive Behavioural Analysis System of Psychotherapy (CBASP) is a form of therapy specifically designed to treat individuals with chronic depression. CBASP combines a number of elements, with a focus on teaching the client to become aware of their interpersonal behaviour and its consequences.
Arm Title
CBASP Without DPI
Arm Type
Experimental
Arm Description
In this arm CBASP will be delivered without Disciplined Personal Involvement (DPI) by the therapist.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioural Analysis System of Psychotherapy
Other Intervention Name(s)
CBASP
Intervention Type
Behavioral
Intervention Name(s)
CBASP Without DPI
Primary Outcome Measure Information:
Title
Patient Health Questionnaire - 9 (PHQ-9)
Description
Administered at three weekly baseline assessments and then at every therapy session for all participants over a period of 6 months or up to 20 sessions.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Aged between 18 and 64 years, inclusive Have been depressed for 2 years or longer Have had previous episodes of depression Previous treatment (medication, psychotherapy or both) unsuccessful or participant has relapsed Do not meet any of the exclusion criteria Able to provide informed consent to participate in the study Exclusion Criteria: Received psychological therapy in previous 12 months Current significant substance misuse Presence of learning difficulties Presence of psychosis Unable to commit to the full duration of the study
Facility Information:
Facility Name
NHS Tayside
City
Dundee
Country
United Kingdom
Facility Name
NHS Lothian
City
Edinburgh
Country
United Kingdom

12. IPD Sharing Statement

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Does Disciplined Personal Involvement Precede Change in CBASP?

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