Does Disciplined Personal Involvement Precede Change in CBASP?

• Sponsor: University of Edinburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT02470988
• Collaborator: (none)
• Enrollment: 13
• Locations: 2
• Arms: 2
• Duration (Months): 18
• Patients Per Site: 6.5
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Depression	Behavioral: Cognitive Behavioural Analysis System of Psychotherapy; Behavioral: CBASP Without DPI	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 13 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Jun 1, 2015
• Actual Primary Completion Date: Dec 1, 2016
• Actual Study Completion Date: Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CBASP 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.	Behavioral: Cognitive Behavioural Analysis System of Psychotherapy; Other Names: CBASP
Experimental: CBASP Without DPI In this arm CBASP will be delivered without Disciplined Personal Involvement (DPI) by the therapist.	Behavioral: CBASP Without DPI

Outcome Measures

Primary Outcome Measures

1. Patient Health Questionnaire - 9 (PHQ-9) [6 months]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 64 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NHS Tayside	Dundee		United Kingdom
2	NHS Lothian	Edinburgh		United Kingdom

Sponsors and Collaborators

• University of Edinburgh

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Edinburgh
• ClinicalTrials.gov Identifier: NCT02470988
• Other Study ID Numbers: 15/WS/0027
• First Posted: Jun 12, 2015
• Last Update Posted: Jun 23, 2021
• Last Verified: Jun 1, 2021

• Additional relevant MeSH terms: Depression

Study Results

No Results Posted as of Jun 23, 2021