Is Narrative Reformulation During Cognitive Analytic Therapy Helpful?

NCT02961738 | Completed Phase 2

• 1 other identifier: NRES ref: 10/H0405/53
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

Brief Summary

Narrative reformulation (NR) is an active ingredient of cognitive analytic therapy (CAT) which is assumed to increase engagement and improve outcomes. This trial sought to test these claims. A randomized and controlled dismantling trial method has been designed to investigate treatments outcomes for depressed patients receiving CAT in an Improving Access to Psychological Therapies service. Participants will be randomized to either treatment as usual (full-CAT) or CAT minus narrative reformulation (CAT-NR). The primary outcome measure is the Patient Health Questionnaire (PHQ-9), with secondary outcome measures of anxiety, functioning, helpfulness and the alliance. Outcomes will be assessed at screening, every treatment session and at 8-weeks follow-up. The trial will enable as assessment of the utility of NR during CAT. and whether CAT appears suitable for treating depression in Primary Care.

Conditions

Depression

Outcome Measures

Primary Outcomes (1)

• Change in depression at end of treatment via the Patient Health Questionnaire-9 (PHQ-9)

  This measure screens patients in Primary Care for depression. Scores on the PHQ-9 range from 0-27, a score of \>10 on the PHQ9 used as a cut-off point for identifying clinical caseness. The PHQ-9 is widely recognised as a valid and reliable measure of depressive symptoms items mirror DSM criteria for symptoms of depression.

  At 16 weeks.

Secondary Outcomes (4)

• Change in anxiety at end of treatment via the Generalized Anxiety Disorder-7 (GAD-7)

  At 16 weeks

• Change in functioning at the end of treatment on the Work and Social Adjustment Scale (WSAS)

  At 16 weeks

• Change in the therapeutic alliance at the end of treatment on the Working Alliance Inventory-Short (WAI-S)

  At 16 weeks

• Change in the helpfulness of the therapy via the the Helpful Aspects of Therapy (HAT)

  At 16 weeks

Study Arms (2)

Full-CAT

ACTIVE COMPARATOR

Participants in this arm receive an intervention of a full 8-session course of cognitive analytic therapy (CAT). This means that they are assessed then then receive a narrative reformulation, that then leads onto a sequential diagrammatic reformulation and then the change methods and completion.

Behavioral: Cognitive Analytic Therapy (CAT)

An 8-session CAT without narrative reformulation (CAT-NR)

EXPERIMENTAL

Participants in this arm receive an intervention of a full 8-session course of cognitive analytic therapy (as described above), but crucially with the narrative reformulation (NR) aspect removed. All other aspects of treatment remain the same.

Behavioral: Cognitive Analytic Therapy (CAT)

Interventions

Cognitive Analytic Therapy (CAT) BEHAVIORAL

Cognitive Analytic Therapy (CAT) is a relational, integrative and time-limited psychotherapy. This is a study with two active arms. Therefore in the full CAT arm the participants receive the full therapy, but in the CAT-NR arm participants get CAT with the narrative reformulation aspect removed.

An 8-session CAT without narrative reformulation (CAT-NR); Full-CAT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• clinical diagnosis of depression (conducted using DSM-IV criteria)
• participants needed to reach caseness (i.e. score 10-21) on the PHQ-9

You may not qualify if:

• a PHQ-9 score \<10
• not meeting DSM criteria for depression
• significant risk issues
• co-morbid anxiety disorder
• previous in-patient admission
• significant amount of previous contact with mental health services
• visual impairment
• non-English speaking
• history of overdoses/self-injury
• currently abusing substances

Sponsors & Collaborators

• University of Sheffield: lead

Study Sites (1)

Clinical Psychology Unit, Department of Psychology, Uni of Sheffield

Sheffield, S10 2TN, United Kingdom

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Glenys Parry, PhD

  Professor of Mental Health

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: IAPT Programme Director and Consultant Clinical Psychologist

Study Record Dates

• First Submitted: October 20, 2016
• First Posted: November 11, 2016
• Study Start: January 1, 2011
• Primary Completion: January 1, 2014
• Study Completion: January 1, 2015
• Last Updated: November 11, 2016

Record last verified: 2016-11

Locations

GB (1)