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DepressionPhase 2/3NCT02961738

Is Narrative Reformulation During Cognitive Analytic Therapy Helpful?

A Phase 2/3 study testing Cognitive Analytic Therapy (CAT) in people with Depression, run by University of Sheffield at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Depression
What is being tested?
Cognitive Analytic Therapy (CAT)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
95 participants
Where
1 siteUnited Kingdom
Study dates
Jan 2011to Jan 2015
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 10Show fewer
  • visual impairment
  • non-English speaking
  • history of overdoses/self-injury
  • currently abusing substances

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • Clinical Psychology Unit, Department of Psychology, Uni of Sheffield

    Sheffield, S10 2TN

Other trials in United Kingdom

About this study

Official title: Efficacy of Narrative Reformulation During Cognitive Analytic Therapy: A Randomized Dismantling Trial

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.

Read the detailed description

Rationale Despite extensive outcome research validating psychotherapy in general as an effective treatment, the outcome literature has been slower to identify the effective, active ingredients of individual therapies. It has been proposed that different active ingredients within therapy relate to outcomes; and definitive technical features are hypothesised to gain importance as psychopathology increases. Therefore research is necessary which compares components of overall treatments to assess their contribution to outcome.

Cognitive analytic therapy (CAT) is a brief therapy (16 or 24 session intervention) drawing upon components of cognitive, and psychodynamic psychotherapies. CAT proposes the use of specific interventions at identified time points within therapy, such as the reformulation letter after a period of assessment. This narrative account reformulates distress, explicitly linking problematic repetitive behavioural patterns with their developmental origins. The client's current life situation is then described alongside target problems and their underlying maladaptive procedures. The reformulation letter is considered a 'crucial therapeutic task' and 'powerful agent of change', but its ability to act in such a manner is largely assumed as the evidence base for these claims has been poorly researched.

Reformulation Despite numerous claims regarding the benefits of cognitive case formulation, there is a paucity of methodologically sound research. This is magnified when looking specifically at the CAT reformulation process. Existing research focuses on accuracy, and whilst some research does exist regarding the impact of reformulation, these are narrative case studies and cannot be generalised. Research utilising the single case experimental design methodology has identified evidence of sudden gains at the point of reformulation.

Depression The introduction of the Increasing Access to Psychological Therapies (IAPT) initiative has focussed on the use of brief, evidence based therapies for this client group and particularly CBT at step 3 of a stepped care model. However, CAT is increasingly used in primary care settings where a naturalistic evidence base is growing regarding its effectiveness for treating depression. The contract can be shortened where 'the threshold to consultation is low' and patients symptomology suggests mild disturbance. Working with predetermined time limits acts to heighten the therapeutic process whilst protecting against over-dependence; hence time-limited interventions can be as clinically effective as lengthy therapy for most people. Brief CAT interventions may therefore be of use for mild to moderate depression.

Aims

The proposed study aims to:

  1. Investigate the impact of reformulation letters with mild-moderately depressed clients in terms of the therapeutic alliance and the helpfulness of therapy
  2. Compare the outcomes (symptom amelioration) for depressed clients receiving a reformulation letter as part of therapy and those who don't receive the reformulation letter over time including follow-up.
  3. Provide initial practice-based evidence of the effectiveness of 8-session CAT in Primary Care with depressed clients.

Hypotheses

Clients receiving a reformulation letter will:

  1. Display enhanced therapeutic alliances in comparison to clients receiving CAT without the letter.
  2. Perceive therapy as more helpful in comparison to clients receiving CAT without the letter.
  3. Achieve better outcomes (greater symptom amelioration) in comparison to clients receiving CAT without the letter.

Theoretical and Clinical Implications The proposed study will add to the nascent evidence base for CAT, with regard to the impact of the reformulation letter on therapeutic processes, outcome and effectiveness. Comparing the impact of receiving a reformulation letter versus excluding this specific event allows its effects to be isolated. This contributes to theoretical understandings of the active ingredients of CAT, and more particularly the role of this specific tool. In addition this may inform the debate surrounding the role of specific versus non-specific contributions in therapy. Identifying tools that augment treatment effectiveness offers the potential to improve therapeutic outcomes.

Improved understanding of how specific tools augment therapeutic processes and affect outcomes has clinical utility. Producing and negotiating reformulation letters takes valuable therapist, and in-session time. Their use, impact and perceived helpfulness are therefore important to investigate thoroughly. This is perhaps of greater importance in brief therapies, where time is a valuable resource. Furthermore, exploring the potential utility of a brief 8-session CAT for primary care mental health problems provides a test of whether CAT could be further adapted and shortened to match the service demands of Primary Care.

Design Utilising a randomised deconstruction methodology, participants will be randomly allocated into one of two active study arms (e.g. 'reformulation letter CAT' or 'no reformulation letter CAT'). Outcome measures will be matched and taken on a session-by-session basis, prior to, during, and following CAT treatment in both arms to enable the comparison of relative efficacy.

Method Participants Participants will be recruited via Barnsley PCT's 's Improving Access to Psychological Therapies (IAPT) service. They will be working age adults (18-65), referred to primary care mental health services with mild to moderate depression.

The study aims to recruit 24 participants in total.

For supervisory purposes, fidelity to the CAT model will be assessed using:

A measure of CAT competence (CCAT; Bennett \& Parry, 2004). The CCAT measures therapist competence over ten domains related to practice and model characteristics. Validity, reliability and internal consistency have been established as sufficient (Bennett \& Parry, 2004).

Procedure A Consultant Cognitive Behavioural Psychotherapist will identify clients meeting the inclusion criteria for the study. Suitable participants will be provided with an information sheet explaining the research and inviting them to participate. Clients agreeing to participate will be asked to sign a consent form. The consent form clarifies that participants have read the information sheet and had opportunities to ask questions. The voluntary nature of participation, confidentiality, and right to withdraw at any time is stated. Consent will be sought to audiotape therapy sessions for supervision purposes. Once consent to participate has been established the identified clients details will be passed to the research team for randomisation.

Participants will be randomly allocated into one of two arms ('letter' or 'no letter') using the GraphPad (2005) computer randomisation software package. Randomised participants will be offered an 8-session course of CAT. The CAT will be delivered by one of three trainee clinical psychologists in their final year of training, one of which is the researcher. All of the trainees have completed a two-day introductory CAT workshop, in addition to standard clinical psychology training to date. To minimise therapist effects participants in each arm will be equally distributed among the team.

All participants will receive eight sessions of CAT with a follow-up appointment eight weeks post-therapy. Assessment will take place over the initial two sessions followed by reformulation at session three. At the reformulation stage 12 patients ('letter' arm) will receive a reformulation letter and provisional sequential diagrammatic reformulation in line with standard CAT practice. 12 patients ('no letter' arm) will receive the SDR without a reformulation letter at session 3. The remaining intervention and termination procedures will follow standard CAT procedures. Patients in both arms will receive, and be invited to produce, a goodbye letter at termination. All participants will be invited to attend a follow-up session eight weeks post-therapy.

To ensure model adherence all therapy sessions will be taped for supervision purposes and reviewed by the CAT qualified, and supervisor-trained supervisor. A minimum of one full taped session from each therapist will be assessed for model adherence by the supervisor using CCAT. In addition, taped excerpts from sessions will be routinely reviewed in supervision; therapists will be invited to employ CCAT as a self-reflective tool in preparation for this. Issues of non-adherence will be considered a training implication, representative of areas for improvement and addressed via standard supervisory procedures. Non-adherence will not preclude data inclusion for the purposes of this research; rather it will be addressed as a limitation of the study related to therapist experience.

Data Analysis To allow comparisons between the two active study arms the primary outcome variables relevant to each hypothesis will be subject to analysis using ANOVA. Trend analyses will be additionally conducted on session-by-session data to highlight and compare patterns of change within the study arms over time. On the pre-post data assessments of clinical and reliable change in each arm will be calculated and compared using the Reliable Change Index (RCI; Jacobson \& Truax, 1991). Outcome data from the PHQ9 will be used to calculate the reliable change index (RCI; Jacobson \& Truax, 1991). This identifies reliable and clinically significant changes at small (z > 1.96, p<.05), medium (z > 2.58; p<.01), and large (z > 3.29, p<.001) effect sizes. Power analysis suggests sufficient power for a Between x Within Subjects ANOVA, paying particular attention to the Groups x Time-Points interaction effect. Assuming a 'medium' effect size of f = .25, a significance level of alpha = .05, and 2 groups of participants providing data at four time points (pre, reformulation, post, and follow up) the proposed total sample size of 24 gives 80% power. Power analysis also suggests sufficient power to conduct a trend analysis form of ANOVA to investigate patterns of change over time (session-by-session data). Assuming a 'medium' effect size of f = .25, a significance level of alpha = .05, and 2 groups of participants providing data at eight time points (session-by-session data excluding follow up) the proposed sample size of 24 will give 95% power.

Hypotheses

Clients receiving a reformulation letter will:

  1. Display enhanced therapeutic alliances in comparison to clients receiving CAT without the letter.
  2. Perceive therapy as more helpful in comparison to clients receiving CAT without the letter.
  3. Achieve better outcomes (greater symptom amelioration) in comparison to clients receiving CAT without the letter.
Conditions
Depression
Being tested
Cognitive Analytic Therapy (CAT)
Medical subject headings
Depression

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive Analytic Therapy (CAT)Behavioural

    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.

Study groups in NCT02961738
Study groupRoleWhat they receive
Full-CATActive comparatorParticipants 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.
Receives: Behavioral: Cognitive Analytic Therapy (CAT)
An 8-session CAT without narrative reformulation (CAT-NR)ExperimentalParticipants 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.
Receives: Behavioral: Cognitive Analytic Therapy (CAT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: At 16 weeks.

Secondary outcomes (4)
  1. Change in anxiety at end of treatment via the Generalized Anxiety Disorder-7 (GAD-7)

    This measure screens patients in Primary Care for the presence of generalized anxiety, with the recommended cut-off point for caseness being >10. The GAD-7 is recommended as a useful tool for assessing initial anxious symptom severity and also monitoring outcomes in Primary Care.

    Measured: At 16 weeks

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

    The WSAS measures the impact of mental health difficulties on aspects of daily functioning. Scores on the WSAS range from 0-40, a higher score on the scale indicates a higher level of disability on daily functioning. The WSAS is used as a measure of functional impairment in Primary Care.

    Measured: At 16 weeks

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

    This measure assesses the strength of the therapeutic alliance across three subscales -tasks, goal agreement and quality of therapeutic bond. The WAI-S has been found to have a good internal reliability and predictive validity.

    Measured: At 16 weeks

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

    This is measure gains quantitative and qualitative information on the patient's perceptions of the helpfulness of individual sessions and asks ratings of helpful and/or impeding events.

    Measured: At 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Nov 2016 (estimated)
  2. Study startJan 2011
  3. Primary completionJan 2014
  4. Study completionJan 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
95 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02961738
Sponsor's protocol ID
NRES ref: 10/H0405/53
Status last verified
Nov 2016
First submitted
20 Oct 2016
Last updated
11 Nov 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Cognitive Analytic Therapy (CAT) in people with Depression, run by University of Sheffield at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in depression at end of treatment via the Patient Health Questionnaire-9 (PHQ-9) (time frame: At 16 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.

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