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Cognitive Behavioral Therapy for Depression in Individuals With Intellectual Disabilities a Review

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Cognitive behaviour therapy (CBT) for anxiety and depression in adults with mild intellectual disabilities (ID): a pilot randomised controlled trial

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Abstract

Background

Several studies take showed that people with intellectual disabilities (ID) have suitable skills to undergo cognitive behavioural therapy (CBT). Case studies have reported successful apply of cognitive behavioural therapy techniques (with adaptations) in people with ID. Modified cognitive behavioural therapy may be a viable and constructive arroyo for the handling of depression, feet, and other mood disorders in ID. To date, two studies have reported group-based manaulised cognitive behavioural treatment programs for depression in people with mild ID. However, at that place is no individual manualised programme for anxiety or depression in people with intellectual disabilities. The aims of the study are to make up one's mind the feasibility of conducting a randomised controlled trial for CBT in people with ID. The data will inform the power calculation and other aspects of carrying out a definitive randomised controlled trial.

Methods

Thirty participants with mild ID will be allocated randomly to either CBT or treatment equally usual (TAU). The CBT group will receive upwardly to 20 hourly private CBT over a period of four months. TAU is the standard treatment which is available to any adult with an intellectual disability who is referred to the intellectual disability service (including care management, community support, medical, nursing or social back up). Beck Youth Inventories (Brook Anxiety Inventory & Beck Depression Inventory) will be administered at baseline; end of handling (4 months) and at six months to evaluate the changes in depression and anxiety. Customer satisfaction, quality of life and the wellness economics will exist secondary outcomes.

Discussion

The broad outcome of the study will be to produce clear guidance for therapists to apply an established psychological intervention and place how and whether it works with people with intellectual disabilities.

Trial registration

ISRCTN: ISRCTN38099525

Peer Review reports

Groundwork

The level of psychopathology in people with intellectual disabilities (ID) is higher than in the general population [ane] with depression, anxiety and mixed affective disorder existence the commonest diagnoses. The prevalence rates for melancholia disorder and anxiety in a random community sample of 90 adults with ID using a structured cess and International Classification of Diseases (ICD-10) criteria were 8.eight% and 14.4% respectively [2]. Two recent studies which compared nativity cohorts of adults with and without ID found a four [3] to six fold [4] increment in mutual affective disorders in adults with balmy ID.

It has been suggested that psychotherapy in full general is non effective in people with ID [5–9]. This is possibly due to long-held assumptions that people with ID have bereft intellectual capacity to use talking therapies likewise as a lack of instruments to measure out change in symptoms, "therapeutic disdain" [ten], a reluctance to piece of work collaboratively and to empathise the mental globe of the patient [xi]. Nevertheless, in recent years, there has been a greater focus on the psychological needs of people with ID, and therapeutic optimism borne out of greater agreement of the adaptations required to improve interventions for this group. Recent limited prove suggests that at least a year's psychodynamic orientated therapy with adults across the range of intellectual inability leads to positive outcomes in improving emotional intelligence [12].

Evidence from work with children suggests that a mature cognitive function may not exist necessary for an private to make use of cerebral behaviour therapy (CBT) [13]. Indeed some inquiry has plant that people with mild to moderate intellectual disability are able to establish links between thoughts and feelings, an important rationale underpinning CBT [14].

Successful use of CBT has been reported in example studies of adults with mild intellectual disability who offended exhibited trouble behaviours [fifteen], anxiety [xvi] or suffered with long term psychotic symptoms [17]. A meta-analysis of the efficacy of psychotherapy in adults with intellectual inability [eighteen] constitute that cognitive behavioural methods were used in xiii% of all the studies reviewed. The outcome of this meta-analysis suggested an upshot size for CBT of iii.08. Notwithstanding nigh CBT interventions have focused on the behavioural rather than cognitive aspects of the interventions [19, 20] looking at observable behaviour rather than psychological modify as the outcome measure.

At that place are many challenges to conducting well designed randomised trials (RCTs) in this field, including ethical objections, the need to involve carers and lack of resources for the intervention [21]. Merely 2 RCTs have been published using CBT in ID and these addressed anger management in secure units [22] and in a community setting [15] using cocky management and cognitive techniques [23–25].

Cognitive behaviour techniques in people with ID are ofttimes adapted to include use of pictures, role plays and simpler questioning styles. Therapy may need to proceed at a slower pace with therapy sessions shorter than the usual 50 minutes [26]. Nosotros are not enlightened of whatsoever general treatment manuals for CBT in adults with ID despite increasing demand for grooming.

In summary, the evidence for efficacy of CBT in people with mild ID is weak and based on modest instance studies or clinical trials that have meaning methodological shortcomings [27]. In addition, positive outcome perchance associated with spontaneous remission in symptoms of depression and/or feet [28, 28]. Reliable and valid effect measures are rarely used [18], and the treatments are not standardised (see Periodical of Practical Research in Intellectual Disabilities special event, 2006).

The rationales for proposing this written report are:

  • A poor testify base for efficacy of psychological treatments in people with ID;

  • Exclusion from access to established wellness interventions for common mental disorders of this population [xxx];

  • Little agreement of how and why treatments established in other populations might be effective in adults with ID.

This is a preliminary written report in order to adapt and operationalise a standard intervention for a specific service user group. The broad result of the written report will be to produce clear guidance for CBT trained therapists to apply the intervention and place how and whether it works in this group.

Hypothesis

Cognitive behaviour treatment is more than clinically and cost constructive than treatment as usual for depression, anxiety and mixed affective states in adults with balmy intellectual disabilities.

Objectives

The aims of the present trial are:

  • To develop a manual outlining how to carry out cognitive behavioural treatment for common mental disorders in adults with mild ID.

  • To determine the feasibility of conducting a randomised controlled trial of individual CBT versus handling every bit usual (TAU) for the handling of depression and feet in adults with mild ID.

  • To use data arising on differences between CBT and TAU to inform a power adding for numbers in a definitive randomised controlled trial.

  • To place the clinically useful elements in the treatment manual.

  • To investigate satisfaction with the intervention and service costs.

Methods/Pattern

Study Design

Potential participants' referrals volition be taken from professionals across ii local intellectual disability services in the London boroughs of Camden and Islington in the Britain, equally well every bit new referrals that fulfill inclusion criteria. Participants will be randomly allocated to Cerebral Behavioural Therapy plus treatment as usual (CBT) or Handling as Usual (TAU). Figure i shows the trial design.

Figure i
figure 1

CBT Report Flow Diagram.

Full size image

Screening and participant recruitment

A total of thirty (north = 30) participants will be recruited for the study. Potential participants will be screened for the trial using the depression and feet components of the Mini Psychiatric Assessment Schedules for Adults with Developmental Disabilities (Mini PAS-Add) [31]. Those with scores of more than 10 for depression and more than seven for anxiety will be eligible and randomized into the study. The range of scores indicating severity is between 11 and 32 for depression and 7-18 for anxiety.

Inclusion criteria:

  • Participants will be adults (over eighteen years of age) who have balmy intellectual disability (as adamant on the service register).

  • Have a disorder according to one of the post-obit International Classification of Diseases-10 (ICD-10) [32] codes: F 32, 33, 34, 34, 38, 40, 41 (anxiety, depression or mixed affective states).

  • Each participant volition besides require an informant, who has known them for at to the lowest degree six months, and who will also exist available throughout the study to complete assessments.

Exclusion criteria:

  • Participants with co-morbid conditions of substance misuse, autism and those currently receiving psychological treatment.

  • Service users with moderate/astringent ID.

Randomisation

The randomization procedure (randomized permuted blocks) will be supervised past Robert Blizard, statistician, and administered by a departmental secretarial assistant (allocation concealment). The research assistant who will conduct out the clinical and toll assessments (at baseline, end of treatment and follow-up) will remain blind to the treatment allocation of the participants until they accept reached the end of the study.

Intervention: Manualised Individual Cerebral Behavioural Therapy (CBT)

The participants will receive up to 16 weekly one-to-i handling sessions of 60 minutes each offered over a period of four months. The CBT will exist delivered by qualified CBT. The CBT manual will be developed in the starting time phase of the study by the enquiry team comprising of specialists in the fields of intellectual disabilities, CBT and health interventions as well every bit clinical psychologists and speech communication and language therapists who have worked with people with intellectual disabilities.

A support worker also will be employed for the trial to assist the participants through the handling. His/her duties will involve facilitating appointments for those receiving CBT session and assist homework tasks.

The CBT therapists delivering the intervention volition be supervised past the Consultant CBT Therapists (MS) and the support worker volition exist supervised past the Consultant Psychiatrist (AH).

Control Group

Treatment Equally Usual (TAU) is defined as the standard handling that would be available to whatever developed with an intellectual disability who has been referred to the intellectual disability service. This includes intendance management, medical, nursing, psychological input and/or social support.

Primary outcomes

Beck Anxiety and Low Inventory Youth (BAI-Y & BDI-Y): Two subscales from the Beck Youth Inventories (BYI) [33] will be used to measure the severity of the cognitive accepts of depression and/or feet. This is a self-report assessment where each subscale consists of 21-items that are rated forth a iv- point Likert scale ('never', 'sometimes', 'often' or 'always'). The participant is required to rate each item in the calibration that best represents their current mood peculiarly during the last 2 weeks. Both subscales will exist administered at baseline, end of treatment (four months) and at a six months follow-upwardly. We accept called the Youth Inventories because they are particularly sensitive to cognitive modify and brief and simple in their language which volition only require minimal alter (for example the word "schoolhouse" volition be replaced by "college" or "piece of work"). This point is of special importance in people with ID who may take difficulty in cocky reporting thoughts and emotional states. A questionnaire that is couched in accessible terms is invaluable in assisting people with balmy ID to communicate their emotional and social distress. In addition, the service users volition be offered assistance to clarify terms past the researcher if necessary. Furthermore, inquiry has shown that the Beck Inventories can reliably and consistently be used with people with mild ID [34].

Secondary Outcomes

Customer satisfaction questionnaire (CSQ-8)[35]: Satisfaction with treatment will be measured past using a modified client satisfaction cocky-assessment questionnaire that consists of viii statements of satisfaction eliciting the client's perception of the mental wellness service/intervention rated on a four point Likert scale at four months from baseline (i.e. end of handling).

Manchester Curt Cess of Quality of Life (MANSA)[36]: This is a quality of life questionnaire that consists of 16-items derived from the Lancashire Quality of Life Profile [37]. MANSA comprises 4 objective questions and 12 subjective questions. The subjective items assess satisfaction with life as a whole, employment condition, financial situation, number and quality of friendships, leisure activities, accommodation, personal safety, living system ( living with others or alone), sex activity life, relationship with family, physical health and mental health. Each item is rated on a vii-point satisfaction calibration, from ane = 'Couldn't exist worse' to 7 = 'Couldn't be meliorate'. This questionnaire will exist administered at baseline and at four months (i.e. cease of treatment).

Client Service Receipt Inventory (CSRI)[38]: this is a validated tool used to evaluate the toll and use of health resources and services by service users with psychiatric issues and learning disabilities [39, 40]. The questionnaire will exist tailored to adjust the data requirements and broad approach to data collection for this trial. Nosotros will record information such as the utilise (frequency and duration) of health and social care services, hospital attendance and admissions, adaptation and living situations, educational services, income, employment and benefits. Data will be collected direct from the service user, back up workers' and from the service records to make up one's mind service use. Costs volition be measured at baseline and at iv months (i.e. end of treatment).

Qualitative interviews

We volition also carry out fifteen minutes interviews' consisting of open concluded questions with prompts that will focus on obtaining the participant and their carer or support worker's experiences and the process of therapy. These will be administered in one case the intervention has been completed. The interviews will be analysed using NVivo software for themes, commonalities and differences in opinions.

Treatment Manual

The final version of the manual will be informed by the practical use of the manual and the therapists' feedback. A professional person writer volition assist with producing a high quality certificate to allow for an attainable and engaging manual that can be utilised effectively.

Treatment process evaluation

It has been suggested that there are three factors that are of import for successful psychotherapeutic interventions: handling commitment, receipt and enactment [41]. Treatment delivery aims to determine whether the proposed treatment is actually being given by the therapist. Modified CBT will be delivered by a therapist accredited or accreditable with the British Association for Behavioural and Cognitive Psychotherapies. All sessions will be sound taped. The therapist will go along a diary business relationship of his/her interventions. Random samples of ane in 10 therapy sessions (CBT) volition be taken and rated using the Revised Cognitive Therapy Scale [42] to exam its awarding in people with ID. A score of 39 or more volition be taken as indicating adequacy of CBT treatment. Adherence to therapy will exist measured using the checklist that has been devised in the CBT manual adult for the purpose of the study. The checklist will ensure that essential ingredients are covered by the therapist and if non, then the reason shall exist recorded.

Treatment receipt is concerned with whether the handling given is actually understood past the patient. In guild to evaluate this, accessible materials (home/worksheets) will be developed as part of the manual. This process will be led by SM and an Accessible Data Worker who has been developing attainable materials for people with a range of intellectual disabilities for several years. The accessible home/worksheets will be discussed with a service users' consultation grouping with whom we have already established working relationships as a issue of other service related projects.

Treatment enactment suggests that even if the treatment is delivered and understood, it volition non be effective unless the patients human action on this. To determine this attribute the feasibility of the homework tasks will be checked by piloting a selection of interventions with service users and determining whether they tin be undertaken and if non why not. Nosotros anticipate that individuals will have difficulties with motivation or ability to complete their homework, therefore, have enlisted the assistance of the study back up worker in encouraging them to practice so.

Statistical analysis

The information will be managed using SPSS (v 14). The analyses volition focus principally on descriptive data on recruitment rates, characteristics of participants, attrition from therapy and research and the function of the study transmission. We will depict the techniques employed and documented by the therapists. The primary outcomes (hateful scores and confidence intervals) will exist compared at baseline, four months and six months post randomisation for both trial arms. Nosotros shall determine the variance of our outcome measures and the issue size in this feasibility trial in order to inform the power calculation for a definitive RCT. We shall likewise conduct exploratory analyses of factors predicting treatment result such as receipt of medication (antidepressant), age, form of illness, treatment preference and number of sessions received.

All analyses will be by intention-to-treat. The study volition appraise the feasibility of recruitment and attrition from the intervention; applicability of the manualised CBT and participants' and informants' views of the handling. Nosotros will collect demographic data on all those approached; volition determine the proportion of people suitable and those who appoint in the study. Nosotros will summate the means and standard deviations for the BDI-Y and the BAI-Y. Although caution is necessary equally the variance of the event scores in a feasibility study, information technology may not truly reflect this in a future trial. The data will be explored to identify possible predictors of issue and factors related to date and or attrition.

A descriptive analysis of total costs and individual resources utilise components (e.g. primary intendance, therapy) will be conducted.

Whilst the proposed sample size (due north = xxx) for this trial is too small to test for statistically significant differences in clinical or social outcomes between intervention and control groups, it volition investigate the feasibility of the intervention and likely effect size and recruitment potential.

Upstanding considerations

This trial has been canonical by the Articulation UCL/UCLH Committee on the Ideals of Human Research, Committee Blastoff (reference number: 08AL 332).

Informed consent and data sheets

The information sheets and consent forms were adult in an attainable (i.e. easy-to-read) format by an accessible data worker as earlier. The information sheets contained a succinct standard script written in attainable linguistic communication to be used as an help to verbally inform the participants nigh the trial before written informed consent is sought from the individuals who are willing to enter the study. It is essential when working with people with intellectual disabilities to ensure that data is understood by often checking and request the individuals to repeat the data in their own words. Information should also be concise to avoid data overload which can exist counterproductive. The participants also will be given information sheets to take abroad and go over with their preferred carer or support worker in their own time and pace.

Withdrawal from the trial

Participants may voluntarily withdraw from the trial for whatsoever reason. The withdrawal of the patient from the trial will not affect their access to treatment by the relevant intellectual disability service.

Confidentiality

Each participant volition be assigned a unique trial number in order to store and identify their trial data. All data for the duration of the report will be kept in locked cabinets in the researcher's role and on a password locked computer. The data protection policy of the Academy Higher Medical Schoolhouse will be observed for this project, which states a ten yr data storage policy.

Discussion

This will be the beginning randomised controlled trial to evaluate a manualised individual cognitive behavioural therapy in treating common affective disorders in people with mild intellectual disabilities. Successful completion of the pilot randomised controlled trial volition show it is viable to recruit participant with intellectual disabilities to a RCT and to evangelize the treatment. The results from this study are probable to have considerable policy impact regarding accessibility of psychological treatments by people with intellectual disabilities in line with the government'due south policy for Improving Admission Psychological Therapies (IAPT). Too, it will add to the testify base for interventions in people with intellectual disabilities, which is currently thin [43].

Demonstrating clinical and cost effectiveness of modified CBT along with the identifying the clinically useful elements of the treatment manual would have significant benefit in relation to current policies in the United kingdom of great britain and northern ireland set out by the National Plant of Clinical Excellence [44] which advocates CBT as a preferred and effective form of treatment for depression and anxiety disorders in the general population and Valuing People [45] which states that people with intellectual disabilities should have the same access to healthcare every bit people without intellectual disabilities.

Abbreviations

BAI-Y:

Beck Anxiety Inventory Youth

BDI-Y:

Brook Depression Inventory Youth

CBT:

Cognitive Behavioural Therapy

CSQ:

Client satisfaction questionnaire

CSRI:

Customer Service Receipt Inventory

ICD-10:

International Classification of Diseases - x

ID:

Intellectual Disabilities

MANSA:

Manchester Brusque Assessment of Quality of Life

PAS-ADD:

Psychiatric Cess Schedules for Adults with Developmental Disabilities

RCT:

Randomised Controlled Trial

SPSS:

Statistical Package for the Social Sciences

TAU:

Treatment as usual.

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Acknowledgments and Funding

Collaborators:

Richard Lohan, Accessible Data Worker at the Camden Intellectual Disabilities Service, is involved in developing the accessible material and holding consultations with the service users. Lorna Vincent and Matt Broadway-Horner, CBT therapists, are involved in administering the CBT intervention. Renee Romeo, is involved in the health economics data analysis and estimation. Spencer Smith is an experienced professional writer who employed to revise the therapist manual.

Funded by:

The Research for Patient Benefit (RfPB), National Constitute for Health Inquiry (NIHR) program, Britain.

Author information

Affiliations

Corresponding author

Correspondence to Angela Hassiotis.

Additional information

Competing interests

The authors declare that they accept no competing interests.

Authors' contributions

AH, MK and MS conceived and wrote the funding application. AS, MS, MK, Equally, SM and CP contributed towards the developing the therapists CBT manual. SM and KA were involved in the development of the attainable information. KA will be acquiring the data and maintain the dataset. RB and KA volition be involved in the data handling and assay whilst all authors will exist involved in the data interpretation and broadcasting.

All authors read and approved the final manuscript.

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Hassiotis, A., Serfaty, K., Azam, K. et al. Cerebral behaviour therapy (CBT) for anxiety and depression in adults with balmy intellectual disabilities (ID): a pilot randomised controlled trial. Trials 12, 95 (2011). https://doi.org/10.1186/1745-6215-12-95

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Keywords

  • Cognitive Behavioural Therapy
  • Intellectual Disability
  • Service User
  • Intellectual Disability
  • Cognitive Behavioural Therapy

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Source: https://trialsjournal.biomedcentral.com/articles/10.1186/1745-6215-12-95