Development of an intervention manual is one strategy that is foundational for promoting the fidelity with which a health intervention is delivered in research and practice. Although the terms protocol and manual are often used interchangeably in the literature, they may differ in the level of detail they offer in providing guidance for delivering an intervention. Just like the research design, operationalized in the study protocol, is the blueprint for conducting a study, the intervention protocol is the overall plan for providing the intervention. The protocol gives an overview of the intervention components and lists the topics and activities planned for each intervention session or module. Just like the procedure book or standards available for health professionals in practice, the intervention manual is a structured procedural text that outlines the rationale, goals, and content of an intervention, and details the techniques or actions for administering the intervention (Brose et al., 2015; Lorencatto et al., 2013). The manual is a document that describes the theoretical underpinning of the intervention and specifies what exactly is done, how, where, and when to deliver the intervention. Thus, the manual clarifies the logistics for providing the intervention as designed. The procedural information presented in a manual differs with the format of health interventions. For standardized health interventions delivered by interventionists in face‐to‐face or distance format, the manual is available as a book or document that describes the step‐by‐step procedure for carrying out the activities planned for each session and includes scripts for conveying core content. For technology‐based delivery of health interventions, the manual is reflected in the content and other material (e.g. video presentation, exercises) comprising each module. For tailored health interventions, the manual describes the decision rules that interventionists should follow in applying the customization algorithm or that are embedded in the delivery of technology‐based adaptive interventions. In this chapter, the approach for developing a manual is described. The content covered in the manual is specified and illustrated with examples. The potential use of the manual in research and practice is discussed. The intervention theory (Chapter 5) informs the development of the manual. Different elements of the theory provide guidance in detailing what is to be done, why, and how. The theory provides the foundation for describing the theoretical underpinning of the intervention. Including the theoretical underpinning of the intervention assists providers in understanding the health problem and the characteristics of the target client population; in appreciating the importance of the intervention in addressing the problem; and in comprehending how the intervention as‐a‐whole and its components contribute to the desired changes in the outcomes. This knowledge helps interventionists grasp the significance of the intervention as designed and as operationalized. In fact, when surveyed about parts of intervention manuals most valued, health professionals attached greatest importance to the theoretical overview of the intervention and indicated that this helps them understand the rationale for the intervention (Barry et al., 2008). The intervention theory identifies the resources required for providing the intervention. Awareness of the human and material resources helps in the specification of and making available/accessible: the particular resources needed for providing each session or module; the features and quality required for the appropriate use of the resources during intervention delivery; the number or quantity with which the resources should be available; and the rationale (i.e. why) and the technique (i.e. how, where, when) for using the resources. For instance, the delivery of web‐based health interventions demands the availability of information technology (IT) staff who have expert knowledge and experience in manipulating, monitoring, and regularly checking on the functionality of the technology (which is the medium through which the intervention is given). The staff must have good interpersonal skills and must be accessible, when needed, to assist clients in resolving challenges navigating the system or arising technical difficulties clients may encounter. The theory describes the contextual factors that affect the delivery of the intervention. The factors are identified and strategies to address them are described in the manual. Physical (e.g. room temperature) and psychosocial (e.g. some participants dominating the group discussion) factors inherent in the setting in which the intervention is delivered are highlighted and strategies to manage them are suggested. This information sensitizes the interventionists of their possible occurrence and the importance of attending to these factors in order to enhance the delivery of the intervention. Similarly, physical and psychosocial factors, inherent in the clients’ environment that may affect clients’ engagement and enactment of treatment are listed, and ways to handle them are proposed. In detailing the intervention delivery protocol, interventionists are encouraged to discuss the factors with the clients and involve clients in active problem‐solving. Alternatively, this information forms the basis for formalizing the adaptation of the intervention’s activities and treatment recommendations to fit with the life circumstances of clients who commonly encounter environmental factors. The principles and approaches for adaptations are incorporated in the manual. Interventionists’ personal characteristics (i.e. communication skills, interactional style) represent another set of contextual factors that influence the delivery of an intervention (see Chapter 8). To mitigate their potential influence, the manual describes: For example, in the first intervention session, the interventionists are expected to perform the first, conventionally prescribed, activity, which is to introduce themselves to clients. In a research study, the interventionists are advised to state their first name, to clarify their role (i.e. responsible for delivering the intervention), and to share their qualifications that enable them to provide the intervention. The latter may be related to the interventionists’ personal experience with the health problem and the intervention. Sharing personal experiences is useful to reinforce the interventionists’ qualifications, to provide reassurance to clients, and to develop perceived similarity between the interventionists and the clients. However, interventionists are proscribed from overly disclosing private personal information or experience that is irrelevant, distracting, time consuming, and potentially perceived as shifting the focus away from the clients (Jowers et al., 2019). The theory delineates the active ingredients and the mechanism of action through which the intervention impacts the ultimate outcomes, which helps interventionists appreciate the contribution of the intervention. The theory identifies the components that operationalize the active ingredients as well as the sequence for providing the components, and the dose for providing the intervention. This information is integrated into a plan that outlines the number of sessions or modules, and the components to be offered within and over sessions or modules. The theory specifies the goal, content, activities, treatment recommendations, mode of delivery, and the sequence for performing the activities within each component. This knowledge guides the detailing of what is to be done, how, and when. The “what” represents the specific content to be relayed and the specific actions to be carried out. The “how” reflects the selected mode of delivery and the way in which the content is conveyed and the actions are executed. The “when” illustrates the time, within a session or module, at which the specific activity is done. The detailed guide is generated for each session or module, and describes the step‐by‐step procedure to be followed when offering the sessions or modules. Although essential for guiding intervention delivery, intervention manuals are not well received or favorably perceived by interventionists in the research context and by health professionals in the practice context. The main concern is that manuals are at odds with the client‐centered approach to care that is highly and equally valued by providers and clients. Client‐centered care demands flexibility in intervention delivery, which consists of adapting aspects of the intervention and/or its delivery in order to meet the individual characteristics, concerns, and life circumstances of clients. Flexibility is central to the development and maintenance of a good rapport, therapeutic relationship, or working alliance between interventionists and clients. This rapport contributes to clients’ engagement, enactment, and satisfaction with the intervention, and consequently experience of improved outcomes (Borrelli, 2011; Brose et al., 2015). To address this tension between delivering intervention a) with fidelity, by strictly adhering to the intervention manual, and b) with flexibility by attending and responding to individual clients’ concerns and life circumstances, there are calls to incorporate an additional part in the manual. This part covers principles and methods for adaptations of the intervention’s elements that are within the parameters of the intervention theory (Brose et al., 2015; Lewis et al., 2019). The information in this part of the manual specifies what content, activity, treatment recommendation, and mode of delivery can be modified and how, without altering the intervention’s active ingredients. The intervention manual provides directions for delivering health interventions, in the selected mode, and at the specified dose. It is highly recommended to develop a manual for any intervention, whether comprised of a single or multiple components, and whether using a standardized or tailored approach to delivery. It is advisable to generate a comprehensive manual that gives an overview of the intervention, lists the resources required to deliver the intervention as designed, details the step‐by‐step procedure for carrying out the activities planned for each intervention session or module, and indicates possible adaptations to address frequently encountered clients’ individual needs, concerns, or life circumstances (Barry et al., 2008; Hardeman et al., 2008). Whether available in hard or electronic copy, the intervention manual contains separate sections covering: overview of the intervention, required resources, the procedure for carrying out the intervention activities planned for each session, adaptations, and appendices. The content of these sections is described next and illustrated with examples from the manual for delivering the stimulus control therapy for insomnia. The first section of the manual gives an overview of the intervention theory and of the intervention. The overview of the intervention theory is described in the text and summarized in a logic model, as mentioned in Chapter 5. The description covers: (1) the definition of the health problem; the aspects of the problem targeted by the intervention; client, interventionist and setting or environmental factors that influence directly or indirectly (moderate) the intervention delivery and outcomes; the immediate and intermediate outcomes that mediate the intervention’s effects; and the ultimate outcomes; (2) the specification of the intervention’s active ingredients and the respective components, mode and dose of delivery; and (3) the proposed relationships among the contextual factors, intervention, and outcomes. The description is supported by relevant theoretical literature and empirical evidence. Bibliography and additional readings are also cited and referenced (Barry et al., 2008). The overview of the intervention theory serves as a general orientation about what the intervention is about, who receives it, why and how it works. It also identifies the specific components that operationalize the intervention’s active ingredients and that should be absolutely provided (under any circumstance) in order to claim the intervention, as designed, is actually given to clients. The overview of the intervention reiterates the overall goals of the intervention, reviews the components constituting the intervention, and its mode and dose of delivery. The goals and activities characterizing each component are specified. This information is important to clarify the operationalization of the intervention, making explicit the correspondence between the active ingredients and the components. The intervention elements to describe in the overview are illustrated for the stimulus control therapy for insomnia in Table 7.1. TABLE 7.1 Overview of stimulus control therapy. The second section of the manual presents a list of the resources required to carry out the activities planned for each session, in the selected mode. The list includes human and material resources. Human resources relate to persons other than the interventionist who are involved in:
CHAPTER 7
Development of Intervention Manual
7.1 APPROACH FOR DEVELOPING THE INTERVENTION MANUAL
7.2 CONTENT OF AN INTERVENTION MANUAL
7.2.1 Section 1: Overview of the Intervention
Element to describe
Specific element
Example
Name of intervention
Stimulus control therapy
Goals of intervention
Ultimate goals
To reduce the severity of insomnia and promote sleep in clients presenting with chronic insomnia
Desired changes (immediate and intermediate outcomes) mediating intervention’s effects on ultimate outcomes
Enhanced understanding of sleep and of factors that influence sleep
Increased awareness of behaviors that promote sleep and that interfere with sleep
Reassociation of the bed and the bedroom with sleepiness
Development of a consistent sleep pattern
Components and activities
Component 1: Sleep education
Goal: Inform clients about sleep and about factors that influence sleep.
Activities:
Discuss the following topics:
What is sleep and why do we sleep?
What is insomnia and what keeps insomnia going?
What factors influence sleep?
Component 2: Sleep hygiene
Goal: Identify behaviors that promote or interfere with sleep.
Activities:
Discuss the general behaviors that affect sleep (i.e. those related to physical activity, fluid and food intake, and use of caffeine and nicotine).
Explain recommendations to address the behaviors
Encourage clients to reflect on personal performance of these behaviors and to apply the treatment recommendations that are consistent with their performance.
Component 3: Stimulus control instructions
Goal: Reassociate the bed and bedroom with sleepiness and acquire a consistent sleep–wake pattern.
Activities:
Present the instructions related to going to bed only when sleepy, using the bed only for sleep, getting out of bed if cannot sleep and engaging in a quiet activity until sleepy, and waking up at the same time every day; explain reasons for these instructions; and involve clients in finding ways to carry out the instructions.
Discuss how each instruction works
Engage clients in generating strategies to promote application of the instructions
Mode of delivery
Group format involving four to six persons
Use combination of written and oral presentation and group discussion
Written presentation:
Distribute booklet summarizing content pertaining to sleep education and hygiene and stimulus control instructions, for clients to follow through during verbal presentation and for future reference
Verbal presentation: Use simple terms to relay information on sleep education and hygiene and stimulus control instructions
Discussion: Ask questions to get clients to reflect on their beliefs and behaviors, how they relate to insomnia, and what they can do to change general behaviors and sleep habits; assist clients in tailoring instructions to their personal context; explore issues of adherence; involve all clients in responding; and provide feedback to reinforce changes in sleep related behaviors
Dose
Two sessions.
Each session is of 90‐minute duration; given once every other week, over a four‐week treatment period
7.2.2 Section 2: Required Resources
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