Accessibility and public availability of treatment protocols and manuals for evidence-based psychological interventions for severe mental disorders: A systematic survey of randomized trials
Authors: Blithikioti Chrysanthi , Tomei Giuliano , Visconti Fabrizio , Gómez Gómez Irene , Cristea Ioana Alina 
Published: December 2024

Question

The components of evidence-based psychological interventions for mental disorders are described in protocols and manuals, but are these resources accessible or publicly available?

Study selection and analysis

We surveyed randomized controlled trials (RCTs) from six large network meta-analyses of psychological interventions for severe mental disorders (psychotic, borderline personality disorder, substance use disorder, bipolar disorder, anorexia nervosa, bulimia nervosa). Between January and December 2024, we searched for protocols and manuals with a multipronged approach (published protocol, trial registries, author contact, commercial availability. We report the proportion of trials and intervention arms for which protocols or manuals were (1) accessible, i.e., retrievable by any method, and (2) publicly available.

Findings

We included 260 RCTs, with 401 active intervention arms. We retrieved published protocols for 20 RCTs (8%, 95% confidence interval/CI 5% to 12%). For the remaining 240 trials, we contacted 450 authors. Authors shared protocols for 43 trials (18%, 95% CI 13% to 23%), refused to share for 73 (30%, 95% CI 25% to 37%) and did not respond for 101 (42%, 95% CI 36% to 49%). Protocols or manuals were retrievable for 318 (79%, 95% CI 75% to 83%) and publicly available for 88 (22%, 95% CI 18% to 26%) active intervention arms, respectively.

Conclusions

Access to detailed descriptions of psychological interventions, even using multiple methods, is difficult, hampering examinations of treatment components. Relying only on open-access resources and sharing from authors allows access to about one third of trial protocols or manuals.

Funding

European Union (European Research Council)

Key messages

What is already known on this topic

Access to treatment protocols or manuals, which detail the ingredients of psychological interventions and conditions of application, is paramount to evaluating these treatments. There is no previous systematic overview of the accessibility of protocols and manuals.

What this study adds

In a large-scale evaluation of 401 evidence-based psychological interventions for severe mental disorders, studied in 260 randomized trials, sourced from 6 large network meta-analyses, we could retrieve a detailed intervention description, operationalized as a protocol or manual, for about 80% of the active interventions. Almost half of the protocols or manuals were only available commercially, and only around a fifth were publicly available. The retrieval rates are based on a resource-intensive, multipronged approach, through searching multiple sources (papers, trials registries, Google for commercially available manuals) and extensive author contact.

How this study might affect research, practice or policy

Our findings invite to reflection on the utility of developing and evaluating treatments for which the full list of ingredients and conditions of application (the equivalent of the label in drug regulation) are largely inaccessible to the public and difficult to access by other researchers. To improve dissemination of effective psychological treatments-a global mental health priority, public availability of treatment manuals is crucial. Funders, journals, and trial registries could require sharing of treatment protocols, at least for research purposes.