Clinical trial NCT06489639: School-based Treatment of Social Anxiety With Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
Official title: School-based Treatment of Social Anxiety: A Randomized and Controlled Study Using Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Social Anxiety Disorder
Social Anxiety
Adolescent - Emotional Problem
Keywords: social anxiety, adolescents, cognitive behavioural therapy
Lead sponsor: Tampere University
Sponsor class: OTHER
Collaborators: name: University of Helsinki
name: Finnish Institute for Health and Welfare
name: University of Eastern Finland
First posted: 2024-07-08
Enrollment: 156
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled study
Primary purpose: TREATMENT

Brief summary: The goal of this randomized controlled trial is to find out whether the brief, 10-session Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD) is more effective than standard counseling (SC) to treat Social Anxiety Disorder (SAD) among 12 to 17-year-old adolescents with SAD.

Potential participants for the study are identified from school health and well-being services (SHWS). The DOCT-SAD is delivered by method-trained school psychologists working in the SHWS. SC will be provided by non-method-trained SHWS professionals (i.e. school nurses, social workers or school psychologists) according to their routine counselling practice.

The main research questions of the study are:

1. Is DOCT-SAD more effective than SC for alleviating symptoms of social anxiety?
2. Is DOCT-SAD more effective than SC to produce diagnostic remission from primary SAD and alleviating symptom severity associated with SAD?
3. Is DOCT-SAD more effective than SC for alleviating co-occurring depressive symptoms, interference in daily functioning due to worry or fears, and for increasing general well-being, positive mental health, and for improving the quality of life among adolescents with SAD?

Researchers will compare DOCT-SAD with SC to see if DOCT-SAD is effective in the treatment of SAD in adolescents.

Participants will:

* be treated either with DOCT-SAD or SC for 10 weeks.
* be followed up and assessed clinically at six-month and twelve-month follow-up points.

Detailed description: Aim:

The aim of this randomized controlled trial is to investigate whether a brief, 10-session intervention, the Developmentally Oriented Cognitive Therapy for Social Anxiety Disorder (DOCT-SAD; in Finnish Tosi minä -treeni) is more effective than standard counseling (SC) for alleviating symptoms of social anxiety and to treat Social Anxiety Disorder (SAD) among adolescents identified from School Health and Well-being Services (SHWS) of mandatory public schools.

Participants:

Participants comprise of students in the grades 7-9 of the public secondary schools, and students in the 1st or 2nd year-course of public high schools and vocational schools in the Tampere area of Finland. They are aged from 12 to 17 years. All participants will present with primary SAD according to DSM-5 criteria. In total, 156 students will be recruited.

Procedure:

Participants are identified by professionals working in the School Health and Welfare Services (SHWS). Recruitment is enhanced by sending information on social anxiety, SAD and the research project to all SHWS professionals of the participating schools using e-mails, online meetings, and pre-recorded online presentations. In addition, families of students in the participating schools are approached with brief informative leaflets about social anxiety and the study via e-mail. Potential participants for the trial will be identified in the schools using a two-stage screening and detection procedure in the SHWS and a SAD detection toolkit.

In the first stage, adolescents with suspected social anxiety are evaluated by SHWS professionals (i.e., school nurses, school social workers and school psychologists) from their current student clients or from their new encounters with students using the SAD detection toolkit. The detection toolkit consists of: 1. symptom measure of social anxiety (SPIN) with instructions on scoring and the clinical cutoff; 2. treatment suitability evaluation checklist consisting of inclusion/exclusion criteria for the study in an abbreviated form, and 3. pictorially enhanced one-page psychoeducation leaflet designed to help in the differentiation between core symptoms of anxiety and depression, and differentiating between different types of anxiety.

In the second stage, the DOCT-SAD-trained school psychologists, who also have been trained in diagnostic evaluation of SAD, act as consultants for other SHWS professionals. Once contacted by non-trained SHWS professional they discuss with them and review all information gathered. The either confrirm or reject a likely diagnosis of primary SAD. These DOCT-trained school psychologists refer the eligble students to the clinical research interview.

The clinical intake interview:

The clinicical research team evaluates the referred adolescents and assigns clinical diagnoses according DSM-5. The ADIS-5 interview schedule is used for diagnostic assessment of anxiety disorders, and the associated CSR scale for is used to assess the severity of SAD and other anxiety disorders. The K-SADS-PL interview schedule usis used for the diagnostic assessment of other DSM-5 disorders. Subjects who present with primary SAD are asked to participate, and adolescents and their parents who give their written content are taken in to the study.

Randomization:

After intake to the study subjects will be randomized to intervention group (i.e., to receive DOCT-SAD delivered by the school psychologists) or to comparison group (i.e., to receive SC provided by a SHWS professional according to her/his routine professional practice). For DOCT -SAD between 4 and 6 adolescents are recruited to each group randomization is performed during the school term when enough referrals.

Delivery of interventions:

The DOCT-SAD will be delivered by method-trained and weekly supervised school psychologists working in the SHWSs. SC will be provided by non-trained SHWS professionals (i.e. either school nurses, social workers or psychologists) according their routine counselling practice. The school psychologists delivering the DOCT-SAD receive weekly, group-based method supervision.

DOCT-SAD:

The DOCT-SAD is a combined individual/group, ten-session intervention for social anxiety treatment largely based largely on the cognitive therapy program CT-SAD, developed in the University of Oxford, UK. It has been modified and theoretically expanded to address the features and challenges unique to the developmental phase of adolescence. DOCT-SAD consists of four indidual and six group sessions. Parents attend two of the sessions. DOCT-SAD uses the main treatment components from the DOCT-SAD program, derived from the cognitive model of SAD by David M. Clark and Adrian Wells in 1995. These componenets include psychoeducation of SAD, individual/historical symptom formulation according to cognitive model, experiential exercise on the consequences of engaging in safety behaviours, attention training, repeated behavioural experiments, dropping of safety behaviours, imagery rescripting on traumatic memories, and cognitive work on beliefs.

Added theoretical sources of DOCT-SAD include use of the theoretical model of core fears of social anxiety disorder being related to experienced flaws/deficiencies in the self as presented by David Moscovitch in 2009. The development of a acceptable, positive self-identity is seen essential for adolescents, and DOCT-SAD program makes use of original materials instuting therapist and adolescents to work on restructuring dysfunctional thoughts and emotions related to social anxiety in the context of experienced self-image/self-concept. Another theoretical influence is drawn from the reseach on psychotherapeutic use of of self-compassion as an antidote to self-cricism, as developed by Paul Gilbert in 2009, and applied to treatment of social anxiety by Lynne Henderson and colleagues in 2014.

In DOCT-SAD programme emphasis on developmental factors is reflected in the combined individual / group format of the treatment. Positive peer modeling and peer support are encouraged in the group. DOCT-SAD materials are developmentally informed, with much emphasis given to normalization of anxiety, normative fears of being deviant in the eyes of peers, need for being accepted and the normative high priority given to peer opinion. Group and pair exercices and out-of-office behavioural experiments are planned to encourage adolescents to practice abandoning their safety behaviors based on what they believe other people consider acceptable. Brief modules to develop self-compassion are included. As process, adolescents work in DOCT-SAD to progress from negative self-experience, self-criticism and self-concealment to being all the more their authentic self, and lastly to being their authentic self and simultaneously being self-supportive in anxiety inducing social situations. An empahsis is given to finding associations between adolescents' SAD symptoms and their self-experience and perceived flaws and deficiencies in their their self-experience. Repeated pair, group and field practice of dropping of self-concealment as a safety behaviour is performed using behavioral experiments and self-exposuresand home work assignments.

SC:

Standard Counseling (SC) is an intervention consisting of counseling sessions delivered by a school health and welfare (SHWS) professional (i.e., school nurse, school social worker, or school psychologist) to support a student with social anxiety. The defined length of intervention is ten weeks. In SC, routine professional working methods and procedures available to the SHWS professional delivering the intervention are used in the counseling.

In addition to methods, number of sessions, treatment goals, and possible involvement of parents are agreed between the counselor, adolescent and parent in the same way as they are routinely agreed by the SHWS professional in her/his work with the students.

Thus, SC represents an intervention that is routinely delivered by a SHWS professional with a student with social anxiety.

Evaluation of outcomes:

The design of this trial is randomized, controlled trial. Participants in both intervention arms are evaluated prior to treatment, at post-treatment (2,5 months), and at 6-month and 12-month follow-up points aftter the intervention with the same methods and measures.

Clinical change:

Both self-report instuments (SPIN, SAFE, PHQ-9, CALIS-C, CALIS-P, YP-CORE, SWEMWBS, WHOQOL-BREF) and clinical interviews (ADIS-5, with associated CSR scale, K-SADS-PL) are used for assessing clinical change.

Feasibility of DOCT-SAD and SC:

Feasibility of both DOCT-SAD and SC as interventions for the participants, for their parents, and for the professionals delivering the interventions is evaluated after both interventions using a structured interview schedule.

Economic evaluation and additional service use:

An economic evaluation of DOCT-SAD and SC includes an assessment of professionals' time resource allocated for the intervention during the ten weeks, and an evaluation of additional service use of the particpiants in both intervention groups. The professionals delivering DOCT-SAD and SC are interviewed on the total time they have allocated to the intervention using a structured questonnaire. Participants' use of additional (i.e., other than DOCT-SAD or SC) healthcare and counseling services during past six months are evaluated twice: first at the intake interview for the study and for the second time at 12-month follow-up point. A structured survey form is used to collect the service use data.

Eligibility criteria: Inclusion criteria:

* age 13-17 years
* diagnosis of DSM-5 SAD (Social Anxiety Disorder)
* SAD is the primary mental health disorder
* motivation of the adolescent and parent to attend DOCT-SAD / SC as described in the study protocol
* good command of the Finnish language.

Exclusion criteria:

* intellectual deficit
* presence of primary autism spectrum disorder
* marked psychotic symptoms or psyhotic disorder
* severe eating disorder, depression or primary other anxiety disorder requiring acute treatment which need to be prioritized above treatment of social anxiety
* acute suicidality or suicide risk
* substance use or substance use disorder requiring child protection measures
* presence of contextual/environmental risk factors in the participants surroundings which require child protection measures

Primary outcomes:
measure: Self-reported social anxiety symptoms
timeFrame: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up point, and to 12-month follow-up point
measure: Diagnostic status of SAD
timeFrame: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up point, and to 12-month follow-up point
measure: Clinical severity of SAD symptoms
timeFrame: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up
Secondary outcomes:
measure: Self-reported safety behaviours associated with SAD
timeFrame: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up
measure: Self-reported depressive symptoms
timeFrame: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up
measure: Self-reported life interference due to fears and worries
timeFrame: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up
measure: Parent-reported life interference due to adolescent's fears and worries
timeFrame: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up
measure: Self-reported general well-being
timeFrame: From treatment startpoint to treatment endpoint (2,5 months), to 6-month follow-up, and to 12-month follow-up
measure: Self-reported positive mental health
timeFrame: From treatment startpoint to the end of the follow-up period (12 months)
measure: Self-reported quality of life
timeFrame: From treatment startpoint to the end of the follow-up period (12 months)
Other outcomes:
measure: Use of healthcare and consulting services during prior six months
timeFrame: From treatment startpoint to the end of the follow-up period (12 months)
Locations:
city: Tampere
country: Finland
facility: Tampere University
state: Pirkanmaa
Study officials:
affiliation: Tampere University
name: Klaus Ranta, MD, PhD
role: STUDY_DIRECTOR
References: