NCT03426709

Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care.

Efficacy of a Blended Low Intensity Internet-delivered Psychological Program in Patients With Multimorbidity in Primary Care. A Randomized Clinical Trial.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 196 (actual)
• Sponsor: Javier Garcia Campayo · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to assess the efficacy in Primary Care (PC) of a low intensity psychological intervention applied using Information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and diabetes/low back pain) by a randomized controlled trial (RCT). A protocol will be design that combines face to face intervention with a supporting online program that will be tried in a RCT conducted in 3 different regions (Andalucía, Aragón, y Baleares). Our main hypothesis is that improved usual care combined with psychological therapy applied by ICTs, will be more efficacious to improve the symptomatology of multimorbidity, compared to a group with only improved treatment as usual three months after the end of treatment.

Detailed description

Although multimorbidity is highly prevalent, health care systems are designed for the management individual diseases. New strategies are needed to help general practitioners to provide appropriate personalized care to patients. The World Health Organization (WHO) has included comorbidity between depression and a chronic disease as one of the 10 main priorities in global public health. Studies in meta-analysis confirm that the 2 main interventions of first choice for depression are pharmacotherapy and/or psychotherapy, with similar results in the short term but superior in the long term for psychological treatments. Given the difficulty of delivering face to face psychological treatments (high costs) alternative models of delivering treatments have been proposed, emphasizing the role of technologies like Internet. The aim of this study is to assess the efficacy in Primary Care (PC) of a low intensity psychological intervention (8 weeks) applied using Information and communication technologies (ICTs) for the treatment of multimorbidity in PC (depression and diabetes/low back pain) by a randomized controlled trial (RCT). Our main hypothesis is that improved usual care combined with psychological therapy applied by ICTs, will be more efficacious to improve the symptomatology of multimorbidity, compared to a group with only improved treatment as usual three months after the end of treatment. A protocol will be design that combines face to face intervention with a supporting online program that will be tried in a RCT conducted in 3 different regions (Andalucía, Aragón, y Baleares). 180 participants diagnosed with depression and diabetes/low back pain will participate in the RCT. It´s proposed a coordinated study by 4 highly experienced groups with great possibilities of translation and transference to usual clinical practice.

Conditions

• Depression
• Chronic Disease (Diabetes/Low Back Pain)

Interventions

Type	Name	Description
BEHAVIORAL	Low intensity Internet-delivered psychotherapy	The online intervention will be individual and interactive, which will be supported by multimedia material (videos, sound recordings, etc.) and will have internet support. The estimated duration of the program is 8 weeks. Low Intensity Internet-delivered psychotherapy: Psychoeducation, Healthy living habits, Behavioral activation, Positive Psychology, Mindfulness and Compassion

Timeline

• Start date: 2018-11-26
• Primary completion: 2020-03-20
• Completion: 2020-12-21
• First posted: 2018-02-08
• Last updated: 2023-02-28

Locations

4 sites across 1 country: Spain