Can We Boost Treatment Adherence to an Online Transdiagnostic Intervention by Adding Self-Enhancement Strategies? Results From a Randomized Controlled Non-inferiority Trial

Andreea Bogdana Isbăşoiu, Bogdan Tudor Tulbure, Andrei Rusu, Florin Alin Sava, Andreea Bogdana Isbăşoiu, Bogdan Tudor Tulbure, Andrei Rusu, Florin Alin Sava

Abstract

Background: Internet-delivered psychotherapy represents an impactful large-scale solution for addressing psychological disorders. In spite of its flexibility and scalability, the fact that the ones in need have to initiate and sustain the curse of the treatment by themselves comes with considerable downsides in terms of treatment adherence. One solution could be to increase the ease of use and attractivity of the strategies and assignments from such programs. The present study aims to address this issue by incorporating a series of self-oriented strategies to the validated internet-delivered short version of the Unified Protocol (UP). By this mean we intend to complement the symptom-focused assignments, which may be more suitable in a therapist assisted context, with ones designed for self-enhancement, which may be easier approached as self-initiated. Based on a randomized controlled non-inferiority trial we compared the modified version of the UP with the standard short version. Method: The trial design was factorial, with two parallel arms and three measurement moments (baseline, post-intervention and 6-months follow-up). A total of 284 participants were randomly assigned to the intervention or the active control groups. The intervention group (baseline n = 142) received the self-enhanced nine modules of the UP (Self-enhanced 9UP) while the active control (baseline n = 142) received the standard nine modules (9UP). The newly added techniques were inspired by the acceptance and commitment therapy and were specific for self-concepts such as self-compassion or unconditional self-acceptance. Both programs lasted for 9 weeks. The non-inferiority of the Self-enhanced 9UP was tested against a margin of d = -0.35, on the following primary outcome measures: Patient Health Questionnaire 9 (PHQ9) - operationalization for depression; Generalized Anxiety Disorder 7 (GAD7) - operationalization for generalized anxiety or worry; Social Phobia Inventory (SPIN) - operationalization for social phobia; and Panic Disorder Severity Scale-Self Report (PDSS-SR) - that showed participants' level of panic. Treatment adherence was assessed through the drop-out analyses and the engagement in completing the homework assignments. Secondary outcome measures included several self-concept measures: Self-Compassion Scale (SCS); Rosenberg Self-Esteem Scale (RSES); Unconditional Self-Acceptance Questionnaire (USAQ); New General Self-Efficacy Scale (NGSE); and Self-Concept Clarity Scale (SCCS). On the secondary outcomes we explored the potential boost of effectiveness produced by the newly added self-enhancement components. Results: The dropout rates were similar in both groups (approximately 45%) and high overall. Adherence to treatment assignments was also modest and similar between groups (on average participants completed approximately half of the tasks), without a statistically significant bias toward the self-enhancement ones. Overall, both the intention-to-treat and completers analyses yielded no significant group by time interactions for any of the post-intervention and follow-up measurements, but a few non-inferiority analyses suggested that the Self-enhanced 9UP had a significantly weaker effectiveness than the standard 9UP. Within-group analyses showed significant alleviations on all the primary and secondary outcomes for both groups. The effect size estimates were mainly medium and high, and their magnitude tended to be kept also at 6-months follow-up. Discussion: We failed to increase treatment adherence, but we found support with some exceptions, for the non-inferiority hypothesis. Hence, the alterations performed to the 9UP protocol, although they did not boost the treatment attractiveness, they also did not decrease the treatment effectiveness as suggested by most non-inferiority analyses. Likewise, the gain on self-concepts was produced by both groups. Hence, the short version of the UP seems to have the potential of effectively alleviating a larger palette of psychological variables associated with mental health symptoms than previously known. Even though our main objective was only partially achieved, these secondary results are insightful and could open new avenues of research. Clinical Trial Registration: This trial has been registered at ClinicalTrials.Gov (NCT03917550; 17 April 2019; https://ichgcp.net/clinical-trials-registry/NCT03917550).

Keywords: anxiety; depression; non-inferiority trial; self-enhance; transdiagnostic; treatment adherence; unified protocol.

Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

Copyright © 2021 Isbăşoiu, Tulbure, Rusu and Sava.

Figures

FIGURE 1
FIGURE 1
The flowchart displaying participants’ cycle throughout the study.

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