Open access of psychological intervention manuals

Open science is a movement aimed at making research methodologies, protocols, tools, data, analyses and reports accessible as early as possible, to facilitate further research ¹ . Open science of psychological treatments is an area that warrants special attention.

Psychological treatments for mental disorders are increasing­ly being investigated globally, with promising results2, 3. This body of research has resulted in recommendations by the World Health Organization (WHO) on a range of psychological interventions, such as cognitive‐behaviour and interpersonal psychotherapies, as first line treatment options for depression ⁴ . There is also substantial evidence that psychological interventions can be delivered effectively not only by specialist mental health providers, but also by general health staff and community workers, who are more easily available ⁵ . One would then expect that psychological treatment manuals underpinning these findings be readily accessible.

The psychological treatment manual is a key element of the research methodology, because it outlines the various aspects of the intervention, including the psychological techniques used, the number and duration of sessions, and the specific content details. The manual is usually carefully designed, revised after piloting, and possibly adapted to local context, before being used in randomized controlled trials (RCTs).

Papers on RCTs typically include a paragraph describing the treatment provided. However, such a brief description – in the absence of a manual – is insufficient for readers to implement the intervention or replicate the study. Also, the limited details often make it difficult to accurately understand the intervention and interpret the results of the study, which becomes a major challenge when conducting and interpreting meta‐analyses of psychological interventions.

We reviewed a database of 27 trials investigating psychological treatments for common mental disorders delivered by non‐specialist providers in low and middle income countries (LMICs) ³ , in order to explore how many treatment manuals used in the studies were cited and how many were open access.

We defined a psychological treatment manual as a structured form of guidance (written material and instructions to be followed). Manuals were coded as being either generic (i.e., the manual was developed for a non‐specific context and had to be adapted before use) or exact (i.e., the manual is exactly the one used). From an open science perspective, the exact manual needs to be accessible.

We operationalized open access of a psychological treatment manual as one of the following: a) the weblink to the exact manual is included in the trial report; b) there is an explicit offer to make the exact manual available from the authors (with their e‐mail address included), or c) the manual is available online so that it can be found without difficulties by searching its name. With respect to the last option, a search was undertaken by entering the name of the programme or the reference in Google search engine. A full version of the manual had to come up within the first 30 hits.

In 19 of the 27 trials, a manual was mentioned in the text of the report, while in the remaining eight there was no mention of the existence of a manual.

Focusing on the 19 trials for which a manual was mentioned, there were eight manuals that were referenced in the paper's bibliography. Six of the references were for the generic manual adapted for the study, while only two were citations of the exact manual used. Of the remaining 11 studies in which a manual was not referenced in the bibliography, six cited another paper as source for the manual but, when searched, that paper did not cite the manual. Four of 11 cited another paper that, when searched, cited a generic manual in the bibliography. Finally, one study cited another paper that, when searched, cited in turn a further paper that, when searched, revealed no citation for the manual. A flow chart summarizing these findings is available up­on request.

When we investigated open access to psychological treatment manuals, no study was found to provide a direct weblink. Seven manuals could be found when using a Google search (of which six were generic and only one ⁶ was the exact manual used). Only in one study ⁷ , access to the exact manual was offered via e‐mail from the authors. Thus, out of 27 trials, a total of only two (7%) exact treatment manuals could be identified that met our definition of open access.

In summary, only two studies (7%) reporting results of a psychological treatment for common mental disorders in LMICs provided citations to the exact manual used in the study, and only two (7%) provided open access to the manual.

Access to treatment manuals for psychological interventions is important for the replication and independent scrutiny of study results and for the dissemination of effective interventions.

Change is not only needed but also feasible. For example, two relevant RCTs of psychological treatments were released around the same time of the systematic review ³ and were thus not included in our analyses. One included a reference to an online version of the exact manual used ⁸ , and the other offered access to a linked training programme to learn the intervention ⁹ .

Accessibility to treatment manuals is a key aspect of open science of psychological treatments. Mental health journals and research funders should consider setting up mechanisms that require authors of RCTs to make the psychological treatment manuals they used open access.