Behavior Therapy for Adjustment Disorder

Overseen By Stephanie M Hart, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Disqualifiers: Active psychosis, Suicidal ideation, Severe substance use

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

Duration: 6 weeks

150 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that participants have been on stable psychotropic medication (medications affecting mood, perception, or behavior) for at least 4 weeks, so you may not need to stop taking your current medications if they are stable.

What data supports the effectiveness of the treatment Transdiagnostic Behavior Therapy (TBT) for Adjustment Disorder?

Research shows that Transdiagnostic Behavior Therapy (TBT) has been effective in improving symptoms of depression, anxiety, stress, and posttraumatic stress in veterans with affective disorders, suggesting it may also help with Adjustment Disorder. ^{1 2 3 4 5}

Is Transdiagnostic Behavior Therapy (TBT) safe for humans?

The research on Transdiagnostic Behavior Therapy (TBT) for affective disorders in veterans and youths suggests it is generally safe, as no specific safety concerns were reported in the studies. However, more research is needed to fully understand its safety profile. ^{1 2 3 5 6}

How is Transdiagnostic Behavior Therapy (TBT) different from other treatments for adjustment disorder?

Transdiagnostic Behavior Therapy (TBT) is unique because it is designed to treat multiple related disorders with a single approach, rather than focusing on one specific condition. This makes it versatile and potentially more accessible, as it can address symptoms across various disorders, such as depression and anxiety, in one treatment. ^{1 2 5 7 8}

What is the purpose of this trial?

Adjustment Disorder (AjD) is the most common mental health condition diagnosed in Active Duty personnel, and is diagnosed following an extreme stress event such as traumatic loss of a comrade, serious accident or injury, or other intense stress event. Despite its high prevalence, no evidence based treatment for AjD has been subjected to randomized controlled trials. This study seeks to build on the research team's pilot work across several disorders study to benefit service members and Veterans with AjD, a highly prevalent but frequently inadequately treated condition. The investigators will compare the effects of Transdiagnostic Behavior Therapy (TBT) vs treatment as usual which is Moving Forward Problem Solving Therapy (TAU-PST) on AjD symptom outcomes. The investigators hypothesize that TBT will result in greater overall symptom reduction compared to TAU-PST.

Research Team

Ron Acierno, PhD

Principal Investigator

McGovern Medical School at UTHealth Houston

Eligibility Criteria

This trial is for adults over 18 who have served or are serving in the military and have been diagnosed with Adjustment Disorder after a traumatic event. They must be stable on any psychotropic medication for at least four weeks. Those with active psychosis, serious thoughts of suicide, or severe substance use issues cannot participate.

Inclusion Criteria

My mental health medication has not changed in the last 4 weeks.

I have been diagnosed with Adjustment Disorder.

Exclusion Criteria

Suicidal ideation with clear intent

Active psychosis

Severe substance use

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 6 sessions of either Transdiagnostic Behavior Therapy (TBT) or Treatment as Usual-Problem Solving Therapy (TAU-PST)

6 weeks

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Assessments at baseline, post-treatment, 3-month, and 6-month follow-up

Treatment Details

Interventions

• Transdiagnostic Behavior Therapy
• Treatment as Usual-Problem Solving Therapy

Trial Overview The study compares Transdiagnostic Behavior Therapy (TBT) to the usual treatment, which is Moving Forward Problem Solving Therapy (TAU-PST), to see which is more effective in reducing symptoms of Adjustment Disorder in military personnel.

Participant Groups

Group I: Transdiagnostic Behavior Therapy (TBT) Experimental Treatment 1 Intervention

Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.

Group II: Active Comparator: Treatment as Usual-Problem Solving Therapy (TAU-PST) Active Control 1 Intervention

Participants will receive 6, 30-45-minute, manualized, individual therapy sessions.

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

U.S. Army Medical Research and Development Command

Collaborator

Trials

296

Recruited

249,000+

Ralph H. Johnson VA Medical Center

Collaborator

Trials

21

Recruited

5,700+

Findings from Research

Transdiagnostic Behavior Therapy (TBT) was developed and evaluated for veterans with affective disorders, showing significant improvements in symptoms of depression, anxiety, stress, and posttraumatic stress in a study involving 29 participants.

The initial support for TBT was informed by earlier findings from a smaller group of 15 veterans, indicating that a single treatment approach can effectively address multiple related disorders in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and initial evaluation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. Gros, DF.[2021]

Group transdiagnostic behavior therapy (TBT) was found to be feasible and effective for youths aged 16-19 with anxiety disorders, showing significant improvements in anxiety symptoms after 12 sessions.

While TBT led to moderate reductions in anxiety and stress, the effects on depression and overall impairment were less reliable, suggesting that further research with larger samples is needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary Findings for Group Transdiagnostic Behavior Therapy for Affective Disorders Among Youths. Gros, DF., Merrifield, C., Hewitt, J., et al.[2022]

In a study involving 231 participants with anxiety disorders, combining transdiagnostic group cognitive-behavioral therapy (tCBT) with treatment-as-usual (TAU) significantly reduced anxiety symptoms compared to TAU alone, as measured by the Beck Anxiety Inventory and clinician severity ratings.

The results showed a substantial effect size (Cohen's d = 0.76 for BAI and 0.79 for ADIS-5), indicating that tCBT is an effective addition to standard care for improving anxiety disorder symptoms in community mental health settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Group transdiagnostic cognitive-behavior therapy for anxiety disorders: a pragmatic randomized clinical trial. Roberge, P., Provencher, MD., Gaboury, I., et al.[2022]

A study comparing Acceptance and Commitment Therapy (ACT) and Cognitive Behavioral Therapy (CBT) in a psychiatric day hospital with 253 participants showed that both therapies significantly improved everyday functioning and health-related quality of life, as well as reduced anxiety and depressive symptoms.

The results indicated that ACT-based treatment is as effective as CBT for patients with psychiatric and physical health conditions, making it a valuable option in routine hospital care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptance and commitment-based therapy for patients with psychiatric and physical health conditions in routine general hospital care - Development, implementation and outcomes. Burian, H., Böge, K., Burian, R., et al.[2021]

Transdiagnostic cognitive behavioral therapy (CBT) protocols have been developed to streamline treatment for affective disorders by combining overlapping components from various disorder-specific CBT approaches, potentially reducing the number of protocols needed.

These newer transdiagnostic treatments, such as group CBT for anxiety and the unified protocol for emotional disorders, aim to address multiple symptoms and comorbidities simultaneously, making CBT more accessible and cost-effective for both providers and patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Movement towards transdiagnostic psychotherapeutic practices for the affective disorders. Gros, DF., Allan, NP., Szafranski, DD.[2018]

Transdiagnostic cognitive-behavioral therapy (CBT) is an adaptable treatment that can effectively address a variety of anxiety and emotional disorders, potentially improving accessibility for patients.

Clinical trials and meta-analyses indicate that transdiagnostic CBT is as effective as traditional CBT, and may be particularly beneficial for individuals with multiple anxiety and emotional disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transdiagnostic Therapy. Norton, PJ., Roberge, P.[2018]

Transdiagnostic behavior therapy (TBT) was effective in reducing various forms of avoidance in 44 veterans with emotional disorders, showing moderate-to-large effect sizes for situational, thought, and positive emotional avoidance.

The study highlights TBT's potential to address transdiagnostic symptoms across different emotional disorders, contributing valuable insights to the effectiveness of transdiagnostic treatment approaches.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of transdiagnostic behavior therapy on transdiagnostic avoidance in veterans with emotional disorders. Gros, DF., Shapiro, MO., Allan, NP.[2023]

In a study involving 109 participants with affective disorders, group Transdiagnostic Behaviour Therapy (TBT) showed significant improvements in psychiatric symptoms and transdiagnostic impairment, suggesting its effectiveness as a treatment option.

While TBT did not statistically outperform disorder-specific group therapies in all symptoms, it demonstrated about twice the treatment effect size in reducing transdiagnostic impairment and significantly improved comorbid depressive symptoms in patients with social anxiety disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Naturalistic Comparison of Group Transdiagnostic Behaviour Therapy (TBT) and Disorder-Specific Cognitive Behavioural Therapy Groups for the Affective Disorders. Gros, DF., Merrifield, C., Rowa, K., et al.[2019]

References

1. Ireland pubmed.ncbi.nlm.nih.gov

Development and initial evaluation of Transdiagnostic Behavior Therapy (TBT) for veterans with affective disorders. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Preliminary Findings for Group Transdiagnostic Behavior Therapy for Affective Disorders Among Youths. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Group transdiagnostic cognitive-behavior therapy for anxiety disorders: a pragmatic randomized clinical trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Acceptance and commitment-based therapy for patients with psychiatric and physical health conditions in routine general hospital care - Development, implementation and outcomes. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Movement towards transdiagnostic psychotherapeutic practices for the affective disorders. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Transdiagnostic Therapy. [2018]

7. United States pubmed.ncbi.nlm.nih.gov

Efficacy of transdiagnostic behavior therapy on transdiagnostic avoidance in veterans with emotional disorders. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

A Naturalistic Comparison of Group Transdiagnostic Behaviour Therapy (TBT) and Disorder-Specific Cognitive Behavioural Therapy Groups for the Affective Disorders. [2019]