Implementation of the Hybrid Treatment in Clinical Care. A SCED.

NCT ID: NCT05082922

Last Updated: 2023-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-01

Study Completion Date

2023-12-31

Brief Summary

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In society today, mental health problems, specifically stress-, anxiety- and depressive disorders, are a primary cause of long-term sick leave, leading to significant societal costs and suffering. One important issue hindering implementation of successful treatments is that there is a marked co-occurrence between these problems and somatic health problems, such as different types of pain. An important key to solving this problem is to develop a more integrated conceptualization of, and treatment model for, these patients' health problems. Specifically, one way to understand the co-occurrence between mental and somatic health problems is offered by the 'transdiagnostic' perspective. The aim of this project is to implement and evaluate the effectiveness of a transdiagnostic emotion-focused treatment protocol in clinical context. The treatment addresses comorbid mental (stress, anxiety- and depressive) and somatic health (pain) problems and targets core emotion regulation processes that are hypothesized to maintain and exacerbate these problems.

Detailed Description

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Conditions

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Emotional Problem Chronic Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

This study employs a sequential single-case experimental AB design with randomized waiting period lengths (4, 5 or 6 weeks). Included in the design is also standardized pre-post and follow up measurement allowing for single group analysis of change. In addition, we collect qualitative data from patients, practitioners and clinical managers, detailing how the treatment and its implementation are experienced.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Data is collected using a secure digital platform. Outcome assessors will be blinded to baseline length allocations.

Study Groups

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No treatment waiting period

Participants are randomized to a 4, 5, or 6 week waiting period. Weekly measurements are collected throughout this period.

Group Type NO_INTERVENTION

No interventions assigned to this group

Hybrid treatment

Hybrid treatment. Weekly measurements are collected throughout treatment.

Group Type EXPERIMENTAL

Hybrid treatment

Intervention Type BEHAVIORAL

Transdiagnostic emotion-focused treatment provided by a psychologist with, when needed, support of a medical doctor (ensuring adherence to medical guidelines) and a physiotherapist (providing assessment and treatment support in exposure for physical activities). Depending on the length of the waiting period (randomly assigned to be either 4, 5 or 6 weeks), the treatment period varies between 14-16 weeks and contains 10-15 sessions.

Interventions

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Hybrid treatment

Transdiagnostic emotion-focused treatment provided by a psychologist with, when needed, support of a medical doctor (ensuring adherence to medical guidelines) and a physiotherapist (providing assessment and treatment support in exposure for physical activities). Depending on the length of the waiting period (randomly assigned to be either 4, 5 or 6 weeks), the treatment period varies between 14-16 weeks and contains 10-15 sessions.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* \> 11 points on the anxiety or depression subscale, Hospital Anxiety and Depression scale
* somatic health problems (pain \> 3 months) with functional impairment (\>3 on question 2 of the Multidimensional Pain Inventory, MPI, OR \> 20 points on question 21-24 of the Örebro Musculoskeletal Pain Questionnaire, ÖMPQ)

Exclusion Criteria

* severe psychiatric problems requiring immediate other treatment
* current psychological treatment
* recently started psychopharmacological treatment for anxiety or depression (\<3 months prior to planned treatment)
* insufficient mastery of the Swedish language
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Center for Health and Medical Psychology

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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HYBRID2.0

Identifier Type: -

Identifier Source: org_study_id

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